Gastroparesis
Conditions
Keywords
gastroparesis, nausea, vomiting
Brief summary
The principal objective of this multicenter, randomized, placebo-controlled trial is to evaluate whether 4 weeks of treatment with aprepitant will improve nausea as compared with placebo in patients with symptoms of chronic nausea and vomiting of presumed gastric origin.
Detailed description
APRON is a multicenter, randomized, double-masked, placebo controlled trial of 4 weeks of treatment with aprepitant or placebo for patients with symptoms of gastroparesis and related disorders. Screening for eligibility and collection of baseline data will span up to 4 weeks after obtaining informed consent and registration. Eligible patients will consist of patients with symptoms of gastroparesis and will be randomized to either aprepitant (125 mg per day) or placebo for 4 weeks. The symptoms will be measured with the Gastroparesis Cardinal Symptom Index Daily Diary (GCSIDD) for one week at baseline and for four weeks after randomization. In addition, the nausea symptom will be measured daily on a 0 to 100 mm visual analog scale (VAS) for one week at baseline and daily for four weeks after randomization. There will be a 2 week washout period at the end of the treatment to ensure patient safety following the end of treatment.
Interventions
DRUGAprepitant
Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
DRUGPlacebo
Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older at registration * Gastric emptying scintigraphy within 2 years of registration * Normal upper endoscopy or upper GI series within 2 years of registration * Symptoms of chronic nausea or vomiting compatible with gastroparesis or other functional gastric disorder for at least 6 months (does not have to be contiguous) prior to registration with Gastroparesis Cardinal Symptom Index (GCSI) score of greater than or equal to 21 * Significant nausea defined with a visual analog scale (VAS) score of greater than or equal to 25 mm on a 0 to 100 mm scale
Exclusion criteria
* Another active disorder which could explain symptoms in the opinion of the investigator * Use of narcotics more than 3 days per week * Significant hepatic injury as defined by significant alanine aminotransferase (ALT) and aspartate aminotransferase (AST) elevations of greater than 2x the upper limit of normal (ULN) or a Child-Pugh score of 10 or greater * Contraindications to aprepitant such as hypersensitivity or allergy * Concurrent use of warfarin, pimozide, terfenadine, astemizole, or cisapride * Pregnancy or nursing * Any other condition, which in the opinion of the investigator would impede compliance or hinder the completion of the study * Failure to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Improvement in Nausea | 4 weeks | The primary outcome measure is a binary (0,1) variable indicating improvement in nausea or not in the mean of available visual analog scale (VAS) scores over the 28 day treatment period compared to the mean of VAS scores during the 7 day baseline period. The criteria for improvement are either a 25 mm or more reduction in mean VAS or attaining a mean VAS during the treatment period of \< 25 mm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Vomiting (No. Episodes) | 4 weeks | Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Vomiting is the participant's assessment of the number of episodes of vomiting experienced in the past 24 hours. The outcome is the change from baseleine in number of times vomited, where negative numbers indicate improvement in vomiting frequency, and positive numbers indicate worsening in vomiting frequency. |
| Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Retching (No. Episodes) | 4 weeks | Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Retching is the participant's assessment of the number of episodes of retching (heaving as if to vomit, but nothing comes up) experienced in the past 24 hours. The outcome is the change from baseline in the number of retching episodes, where negative numbers indicate improvement in retching frequency, and positive numbers indicate worsening in retching frequency. |
| Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): GCSI Total Score | 4 weeks | The Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): GCSI total score is the average of 3 subscores: Nausea (average of two items: nausea and vomiting), Early Satiety (average of two items: not able to finish normal size meal and feeling excessively full after meals), and Bloating (feeling like you need to loosen your clothes). Each item is the participant's assessment of severity of the symptom during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in GCSI total score, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. |
| Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Nausea Severity | 4 weeks | Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Nausea severity is the participant's assessment of nausea (feeling sick to your stomach as if you were going to vomit or throw up) during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in GCSI score, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. |
| Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Vomiting Severity | 4 weeks | Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Vomiting Severity is the participant's assessment of vomiting during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Vomiting Severity, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. |
| Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Upper Abdominal Pain Severity | 4 weeks | Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Upper Abdominal Pain Severity is the participant's assessment of upper abdominal pain (above the navel) during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Upper Abdominal Pain Severity, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. |
| Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Excessive Fullness Severity | 4 weeks | Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Excessive Fullness Severity is the participant's assessment of excessive fullness (feeling excessively full after meals) during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Excessive Fullness Severity, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. |
| Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Early Satiety Severity | 4 weeks | Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Early Satiety Severity is the participant's assessment of early satiety (not able to finish normal-size meal) during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Early Satiety Severity, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. |
| Platelet Count | 4 weeks | Change from baseline in platelet count |
| Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Bloating Severity | 4 weeks | Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Bloating Severity is the participant's assessment of bloating (feeling like you need to loosen your clothes) during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Bloating Severity, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. |
| Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Overall Symptom Severity | 4 weeks | Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Overall Symptom Severity is the participant's assessment of overall severity of gastroparesis symptoms during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome, change from baseline in Overall Symptom Severity score, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. |
| Clinical Global Patient Impression Score (Patient-rated) | 4 weeks | The Clinical Global Patient Impression Score quantifies the overall relief of the patient's symptom, by asking the participant to consider how they felt over the past week in regard to stomach symptoms and overall well-being, and rate relief of symptoms in comparison to how they felt before entering the study. Possible scores are: -3=very considerably worse, -2=considerably worse, -1=somewhat worse, 0=unchanged, 1=somewhat better, 2=considerably better, 3=completely better. The range of scores is -3 to 3, where higher scores are considered a better outcome. The outcome measure, change from baseline in Clinical Global Patient Impression Score, has a possible range of -6 to +6, with positive values indicating a better outcome (improvement) and negative values indicating a worse outcome. |
| Liver Enzymes and Proteins: Alanine Aminotransferase (ALT) | 4 weeks | Change from baseline in serum alanine aminotransferase (ALT), U/L |
| Liver Enzymes and Proteins: Aspartate Aminotransferase (AST) | 4 weeks | Change from baseline in aspartate aminotransferase (AST), U/L |
| Liver Enzymes and Proteins: Total Protein | 4 weeks | Change from baseline in total protein (g/dL) |
| Hemoglobin A1c (HbA1c) | 4 weeks | Change from baseline in hemoglobin A1c (HbA1c) (%) |
| Glucose | 4 weeks | Change from baseline in glucose (mg/dL) |
| Liver Enzymes and Proteins: Albumin | 4 weeks | Change from baseline in albumin (g/dL) |
| Hemoglobin | 4 weeks | Change from baseline in hemoglobin (g/dL) |
| Hematocrit | 4 weeks | Change from baseline in hematocrit |
| White Blood Cell Count (WBC) | 4 weeks | Change from baseline in white blood cell count (WBC) |
| Red Blood Cell Count (RBC) | 4 weeks | Change from baseline in red blood cell count (RBC) |
| Carbon Dioxide | 4 weeks | Change from baseline in carbon dioxide (mEg/L) |
| Chloride | 4 weeks | Change from baseline in chloride (mEq/L) |
| Sodium | 4 weeks | Change from baseline in sodium (mEq/L) |
| Potassium | 4 weeks | Change from baseline in potassium (mEq/L) |
| Calcium | 4 weeks | Change from baseline in calcium (mg/dL) |
| Blood Urea Nitrogen (BUN) | 4 weeks | Change from baseline in blood urea nitrogen (BUN) (mg/dL) |
| Magnesium | 4 weeks | Change from baseline in magnesium (mg/dL) |
| Creatinine | 4 weeks | Change from baseline in creatinine (mg/dL) |
| PAGI-SYM Severity Index: Gastroparesis Cardinal Symptom Index (GCSI) Score | 4 weeks | PAGI-SYM Severity index: Gastroparesis Cardinal Symptom Index (GCSI) score is the average of 3 subscores: Nausea (average of 3 items: nausea, retching, and vomiting), Fullness/Early Satiety (average of 4 items: stomach fullness, not able to finish normal size meal, feeling excessively full after meals, and loss of appetite), and Bloating (average if 2 items: bloating and stomach visibly larger). Each item is the participant's assessment of severity of the symptom during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The outcome measure, change from baseline in GCSI score, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. |
| PAGI-SYM Severity Index: Nausea/Vomiting Severity Subscore | 4 weeks | The PAGI-SYM Severity index: Nausea/vomiting severity subscore is the average of 3 items: nausea, retching, and vomiting. Each item is the participant's assessment of severity of the symptom during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Nausea/vomiting severity subscore, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. |
| PAGI-SYM Severity Index: Fullness/Early Satiety Subscore | 4 weeks | The PAGI-SYM Severity index: Fullness/Early Satiety Subscore is the average of 4 items: stomach fullness, not able to finish normal size meal, felling excessively full after meals, and loss of appetite. Each item is the participant's assessment of severity of the symptom during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Fullness/Early Satiety Subscore, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. |
| PAGI-SYM Severity Index: Bloating Subscore | 4 weeks | The PAGI-SYM Severity index: Bloating Subscore is the average of 2 items: bloating (feeling like you need to loosen your clothes) and stomach visibly larger. Each item is the participant's assessment of severity of the symptom during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The outcome measure, change from baseline in Bloating Subscore, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. |
| PAGI-SYM Severity Index: Upper Abdominal Pain Subscore | 4 weeks | The PAGI-SYM Severity index: Upper Abdominal Pain subscore is the average of 2 items (upper abdominal pain, upper abdominal discomfort). Each item is the participant's assessment of severity of the symptom during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Upper Abdominal Pain Subscore, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. |
| PAGI-SYM Severity Index: GERD Subscore | 4 weeks | PAGI-SYM Severity index: Gastroesophageal Reflux (GERD) Subscore is the average of 7 items (heartburn during day, heartburn lying down, chest discomfort day, chest discomfort during sleep, regurgitation during day, regurgitation lying down, bitter taste in mouth). Each item is the participant's assessment of severity of the symptom, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in GERD Subscore, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. |
| PAGI-SYM Severity Index: Nausea Severity | 4 weeks | The PAGI-SYM Severity index: Nausea severity is the participant's assessment of nausea (feeling sick to your stomach as if you were going to vomit or throw up) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Nausea Severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. |
| PAGI-SYM Severity Index: Vomiting Severity | 4 weeks | The PAGI-SYM Severity index: Vomiting Severity is the participant's assessment of vomiting during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Vomiting Severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. |
| PAGI-SYM Severity Index: Retching Severity | 4 weeks | The PAGI-SYM Severity index: Retching Severity is the participant's assessment of retching (heaving as if to vomit, but nothing comes up) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Retching Severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. |
| PAGI-SYM Severity Index: Stomach Fullness Severity | 4 weeks | PAGI-SYM Severity index: Stomach Fullness severity is the participant's assessment of stomach fullness during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Stomach Fullness severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. |
| PAGI-SYM Severity Index: Unable to Finish Meal Severity | 4 weeks | PAGI-SYM Severity index: Unable to Finish Meal severity is the participant's assessment of being unable to finish a normal size meal during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Unable to Finish Meal severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. |
| PAGI-SYM Severity Index: Excessive Fullness Severity | 4 weeks | PAGI-SYM Severity index: Excessive fullness severity is the participant's assessment of feeling excessively full after meals during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Excessive Fullness severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. |
| PAGI-SYM Severity Index: Loss of Appetite Severity | 4 weeks | PAGI-SYM Severity index: Loss of appetite severity is the participant's assessment of loss of appetite during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Loss of appetite severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. |
| PAGI-SYM Severity Index: Bloating Severity | 4 weeks | The PAGI-SYM Severity index: Bloating Severity is the participant's assessment of bloating (feel like you need to loosen your clothes) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Bloating Severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. |
| PAGI-SYM Severity Index: Stomach Distention Severity | 4 weeks | The PAGI-SYM Severity index: Stomach distention severity is the participant's assessment of stomach distention (stomach or belly visibly larger) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Stomach Distention severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. |
| PAGI-SYM Severity Index: Upper Abdominal Pain Severity | 4 weeks | The PAGI-SYM Severity index: Upper Abdominal Pain severity is the participant's assessment of upper abdominal pain (above the navel) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Upper Abdominal Pain severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. |
| PAGI-SYM Severity Index: Upper Abdominal Discomfort Severity | 4 weeks | The PAGI-SYM Severity index: Upper Abdominal Discomfort severity is the participant's assessment of upper abdominal discomfort (above the navel) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Upper Abdominal Discomfort severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. |
| PAGI-SYM Severity Index: Lower Abdominal Pain Severity | 4 weeks | The PAGI-SYM Severity index: Lower Abdominal Pain severity is the participant's assessment of lower abdominal pain (below the navel) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Lower Abdominal Pain severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. |
| PAGI-SYM Severity Index: Lower Abdominal Discomfort Severity | 4 weeks | The PAGI-SYM Severity index: Lower Abdominal Discomfort severity is the participant's assessment of lower abdominal discomfort (below the navel) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Lower Abdominal Discomfort severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. |
| PAGI-SYM Severity Index: Heartburn During the Day Severity | 4 weeks | The PAGI-SYM Severity index: Heartburn during the day severity is the participant's assessment of heartburn (burning pain rising in your chest or throat) during the day over the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Heartburn During the Day severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. |
| PAGI-SYM Severity Index: Heartburn When Lying Down Severity | 4 weeks | The PAGI-SYM Severity index: Heartburn when lying down severity is the participant's assessment of heartburn (burning pain rising in your chest or throat) when lying down over the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Heartburn When Lying Down severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. |
| PAGI-SYM Severity Index: Chest Discomfort During the Day Severity | 4 weeks | The PAGI-SYM Severity index: Chest discomfort during the day severity is the participant's assessment of feeling of discomfort inside the chest during the day over the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Chest Discomfort During the Day severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. |
| PAGI-SYM Severity Index: Chest Discomfort During Sleep Time Severity | 4 weeks | The PAGI-SYM Severity index: Chest discomfort during sleep severity is the participant's assessment of feeling of discomfort inside the chest at night (during sleep time) over the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Chest Discomfort During Sleep Time severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. |
| PAGI-SYM Severity Index: Regurgitation During the Day Severity | 4 weeks | The PAGI-SYM Severity index: Regurgitation during the day severity is the participant's assessment of regurgitation or reflux (fluid or liquid from your stomach coming up into throat) during the day over the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Regurgitation During the Day severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. |
| PAGI-SYM Severity Index: Regurgitation When Lying Down Severity | 4 weeks | The PAGI-SYM Severity index: Regurgitation when lying down severity is the participant's assessment of regurgitation or reflux (fluid or liquid from your stomach coming up into throat) when lying down over the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Regurgitation When Lying Down severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. |
| PAGI-SYM Severity: Bitter Taste Severity | 4 weeks | The PAGI-SYM Severity index: Bitter Taste severity is the participant's assessment of bitter, acid, or sour taste in mouth during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Bitter Taste Severity score, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. |
| PAGI-SYM Severity Index: Constipation Severity | 4 weeks | The PAGI-SYM Severity index: Constipation severity is the participant's assessment of constipation during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Constipation Severity score, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. |
| PAGI-SYM Severity Index: Diarrhea Severity | 4 weeks | The PAGI-SYM Severity index: Diarrhea severity is the participant's assessment of constipation during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Diarrhea Severity score, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. |
| Gastrointestinal Symptom Rating Scale (GSRS): Total Score | 4 weeks | The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item questionnaire for participants with gastrointestinal discomfort. The GSRS Total Score is the average of the 15 items. Each item is rated on a 0 to 7 scale, where 0 indicates no discomfort and 7 indicates very severe discomfort. The range of scores is 0 to 7, where higher scores are considered a worse outcome.The outcome measure, change from baseline in GSRS Total Score, has a possible range from -7 to +7, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. |
| Gastrointestinal Symptom Rating Scale (GSRS): Reflux Score | 4 weeks | The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item questionnaire for participants with gastrointestinal discomfort. The GSRS Reflux Score is a measure of how bothered the participant has been by acid reflux during the past week. The range of scores is 0 to 7, where 0 indicates no discomfort and 7 indicates very severe discomfort. Higher scores are considered a worse outcome.The outcome measure, change from baseline in GSRS Reflux Score, has a possible range from -7 to +7, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. |
| Gastrointestinal Symptom Rating Scale (GSRS): Abdominal Pain Score | 4 week | The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item questionnaire for participants with gastrointestinal discomfort. The GSRS Abdominal Pain Score is a measure of how bothered the participant has been by pain or discomfort in the upper abdomen or pit of the stomach during the past week. The range of scores is 0 to 7, where 0 indicates no discomfort and 7 indicates very severe discomfort. Higher scores are considered a worse outcome.The outcome measure, change from baseline in GSRS Abdominal Pain Score, has a possible range from -7 to +7, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. |
| Gastrointestinal Symptom Rating Scale (GSRS): Indigestion Score | 4 weeks | The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item questionnaire for participants with gastrointestinal discomfort. The GSRS Indigestion Score is a measure of how bothered the participant has been by indigestion during the past week. The range of scores is 0 to 7, where 0 indicates no discomfort and 7 indicates very severe discomfort. Higher scores are considered a worse outcome.The outcome measure, change from baseline in GSRS Indigestion Score, has a possible range from -7 to +7, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. |
| Gastrointestinal Symptom Rating Scale (GSRS): Diarrhea Score | 4 weeks | The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item questionnaire for participants with gastrointestinal discomfort. The GSRS Diarrhea Score is a measure of how bothered the participant has been by diarrhea during the past week. The range of scores is 0 to 7, where 0 indicates no discomfort and 7 indicates very severe discomfort. Higher scores are considered a worse outcome.The outcome measure, change from baseline in GSRS Diarrhea Score, has a possible range from -7 to +7, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. |
| Gastrointestinal Symptom Rating Scale (GSRS): Constipation Score | 4 weeks | The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item questionnaire for participants with gastrointestinal discomfort. The GSRS Constipation Score is a measure of how bothered the participant has been by constipation during the past week. The range of scores is 0 to 7, where 0 indicates no discomfort and 7 indicates very severe discomfort. Higher scores are considered a worse outcome.The outcome measure, change from baseline in GSRS Constipation Score, has a possible range from -7 to +7, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. |
| Brief Pain Inventory: Severity Score | 4 weeks | The Brief Pain Inventory: Severity Score is the average of four questions in which the participant rates his or her pain: the worse pain in the past 24 hours, the least pain in the past 24 hours, average pain, and pain right now. The range of possible scores is 0 to 10, with higher scores indicating more severe pain. The outcome measure, change from baseline in Brief Pain Inventory Severity Score, has a possible range from -10 to +10, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. |
| Brief Pain Inventory: Interference Score | 4 weeks | The Brief Pain Inventory: Interference Score is the average of seven questions in which the participant rates the degree to which his or her pain interferes with daily functions and mood: general activity, mood, walking ability, normal work, relationships, sleep, enjoyment of life. The range of possible scores is 0 to 10, with higher scores indicating more interference caused by pain. The outcome measure, change from baseline in Brief Pain Inventory Interference Score, has a possible range from -10 to +10, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. |
| Beck Depression Inventory (BDI) Score | 4 weeks | The Beck Depression Inventory (BDI) survey is comprised of 21 multiple choice questions that relate to depression, cognition, and physical well-being and is used to quantify depression. The BDI total score is the sum of the 21 items, where each item ranges from 0 to 3 (lower scores are less severe, higher scores are more severe). The range for the BDI total score is 0 to 63, where lower scores indicate less depression and higher scores indicate more severe depression. The outcome measure, change from baseline in BDI score, has a possible range from -63 to +63, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. |
| State-Trait Anxiety Inventory (STAI): State Anxiety Score | 4 weeks | The State-Trait Anxiety Inventory (STAI): State anxiety score is the sum of scores from 20 questions relating to state anxiety, which is a temporary state varying in intensity. The possible range of scores is from 20 to 80, with increasing scores considered a worse outcome. The outcome measure, change from baseline in STAI State Anxiety score, has a possible range from -60 to +60, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. |
| Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Nausea (Hours) | 4 weeks | Measure Description: Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Nausea is the participant's assessment of the number of hours of nausea experienced in the past 24 hours. The range is 0 to 24 hours. The outcome measure, change from baseline in number of hours of nausea, has a possible range from -24 to +24, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. |
| Satiety Test, Volume Consumed | 4 weeks | The Satiety Test measures the total volume of liquid (Ensure) that the participant is able to consume. The participant drinks 150 mL of Ensure every 5 minutes until he/she is completely full. The outcome measure is the change from baseline in volume of liquid (Ensure) consumed (mL), where positive values indicate a positive outcome (improvement). |
| Electrogastrography (EGG): Bradygastria (1-<2.5 Cpm) at 4 Weeks, Baseline Measurement | 4 weeks | Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. Normal pacing is considered 2.5-3.7 cycles per minute (cpm). Bradygastria is when the rate of electrical activity in the stomach is \<2.5 cycles per minute for at least 1 minute (a decrease in electrical activity in the stomach). The average power in frequency region is the percentage of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (here, baseline refers to the test performed during screening, not the baseline value of the EGG test) in percent of time with frequencies in the ranges, where negative values for bradygastria indicate improvement (less time in a dysrhythmic state). |
| Electrogastrography (EGG): Bradygastria (1-<2.5 Cpm) at 4 Weeks, 0-30 Post-satiety Measurement | 4 weeks | Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. The 0-30 post-satiety measurement of the test is that taken 30 minutes after the participant consumes Ensure until feeling completely full. Normal pacing is considered 2.5-3.7 cycles per minute (cpm). Bradygastria is when the rate of electrical activity in the stomach is \<2.5 cycles per minute for at least 1 minute. Average power in frequency region is the % of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (baseline refers to test performed during screening, not baseline value of the EGG test) in % of time with frequencies in the ranges. Negative values for bradygastria indicate improvement (less time in a dysrhythmic state). |
| Electrogastrography (EGG): Normogastria (2.5-<3.8 Cpm) at 4 Weeks, Baseline Measurement | 4 weeks | Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. Normal pacing (normogastria) is considered 2.5-3.7 cycles per minute (cpm). The average power in frequency region is the percentage of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (here, baseline refers to the test performed during screening, not the baseline value of the EGG test) in percent of time with frequencies in the ranges, where positive values for normal rates indicate an increase in the normal pacing (improvement). |
| Electrogastrography (EGG): Normogastria (2.5-<3.8 Cpm) at 4 Weeks, 0-30 Post-satiety Measurement | 4 weeks | Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. The 0-30 post-satiety measurement that taken 30 minutes after the participant consumes Ensure until feeling completely full. Normal pacing (normogastria) is considered 2.5-3.7 cycles per minute (cpm). The average power in frequency region is the percentage of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (baseline refers to the test performed during screening, not the baseline value of the EGG test) in percent of time with frequencies in the ranges, where positive values for normal rates indicate an increase in the normal pacing (improvement). |
| Electrogastrography (EGG): Duodenal (>10-15 Cpm) at 4 Weeks, Baseline Measurement | 4 weeks | Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. Normal pacing is considered 2.5-3.7 cycles per minute (cpm). Duodenal is when the rate of electrical activity in the stomach is \>10-15 cycles per minute for at least 1 minute. The average power in frequency region is the percentage of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (here, baseline refers to the test performed during screening, not the baseline value of the EGG test) in percent of time with frequencies in the ranges, where negative values for duodenal indicate improvement (less time in a dysrhythmic state). |
| Electrogastrography (EGG): Tachygastria (3.8-10 Cpm) at 4 Weeks, Baseline Measurement | 4 weeks | Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. Normal pacing is considered 2.5-3.7 cycles per minute (cpm). Tachygastria is when the rate of electrical activity in the stomach is 3.8-10 cycles per minute for at least 1 minute (an increase in electrical activity in the stomach). The average power in frequency region is the percentage of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (here, baseline refers to the test performed during screening, not the baseline value of the EGG test) in percent of time with frequencies in the ranges, where negative values for tachygastria indicate improvement (less time in a dysrhythmic state). |
| Electrogastrography (EGG): Tachygastria (3.8-10 Cpm) at 4 Weeks, 0-30 Post-satiety Measurement | 4 weeks | Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. The 0-30 post-satiety measurement that taken 30 minutes after the participant consumes Ensure until feeling completely full. Normal pacing is considered 2.5-3.7 cycles per minute (cpm). Tachygastria is when the rate of electrical activity in the stomach is 3.8-10 cycles per minute for at least 1 minute (an increase in electrical activity in the stomach). The average power in frequency region is the percentage of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (here, baseline refers to the test performed during screening, not the baseline value of the EGG test) in percent of time with frequencies in the ranges, where negative values for tachygastria indicate improvement (less time in a dysrhythmic state). |
| Electrogastrography (EGG): Duodenal (>10-15 Cpm) at 4 Weeks, 0-30 Post-satiety Measurement | 4 weeks | Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. The 0-30 post-satiety measurement that taken 30 minutes after the participant consumes Ensure until feeling completely full. Normal pacing is considered 2.5-3.7 cycles per minute (cpm). Duodenal is when the rate of electrical activity in the stomach is \>10-15 cycles per minute for at least 1 minute. The average power in frequency region is the percentage of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (here, baseline refers to the test performed during screening, not the baseline value of the EGG test) in percent of time with frequencies in the ranges, where negative values for duodenal indicate improvement (less time in a dysrhythmic state). |
| State-Trait Anxiety Inventory (STAI): Trait Anxiety Score | 4 weeks | The State-Trait Anxiety Inventory (STAI): Trait anxiety score is the sum of scores from 20 questions pertaining to trait anxiety, which is a general propensity to be anxious. The possible range of scores is from 20 to 80, with increasing scores considered a worse outcome. The outcome measure, change from baseline in STAI Trait Anxiety score, has a possible range from -60 to +60, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. |
Countries
United States
Participant flow
Recruitment details
Between April 2013 and July 2015, 126 patients were enrolled at eight participating medical centers, of whom 63 were randomized to aprepitant and 63 to placebo
Pre-assignment details
Adults, 18 years or older, with symptoms compatible with gastroparesis for 6 months, who had a 4-hour gastric emptying scintigraphy test and a total score \>21 on the Gastroparesis Cardinal Symptom Index (GCSI) and a visual analog scale (VAS) mean score of nausea after 7 days of \>25 mm on a 0 to 100 mm scale were considered for enrollment.
Participants by arm
| Arm | Count |
|---|---|
| Aprepitant Aprepitant 125 mg per day
Aprepitant: Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks | 63 |
| Aprepitant-placebo Placebo aprepitant 125mg per day
Placebo: Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks | 63 |
| Total | 126 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 6 | 3 |
Baseline characteristics
| Characteristic | Aprepitant | Aprepitant-placebo | Total |
|---|---|---|---|
| 7-day nausea visual analog scale (VAS) score | 63.0 units on a scale STANDARD_DEVIATION 21.5 | 64.1 units on a scale STANDARD_DEVIATION 20.2 | 63.6 units on a scale STANDARD_DEVIATION 20.8 |
| Age, Continuous | 42.9 years STANDARD_DEVIATION 14.8 | 46.8 years STANDARD_DEVIATION 13.5 | 44.8 years STANDARD_DEVIATION 14.3 |
| Beck Depression Inventory (BDI): Severe depression, No. Do not have severe depression | 52 participants | 53 participants | 105 participants |
| Beck Depression Inventory (BDI): Severe depression, No. Have severe depression | 11 participants | 10 participants | 21 participants |
| Beck Depression Inventory (BDI): Total score | 18.0 units on a scale STANDARD_DEVIATION 11.8 | 18.3 units on a scale STANDARD_DEVIATION 12.6 | 18.2 units on a scale STANDARD_DEVIATION 12.1 |
| Body mass index (BMI) | 27.8 kg/m^2 STANDARD_DEVIATION 8.3 | 28.0 kg/m^2 STANDARD_DEVIATION 7.5 | 27.9 kg/m^2 STANDARD_DEVIATION 7.9 |
| Brief Pain Inventory: Interference score | 4.4 units on a scale STANDARD_DEVIATION 3.1 | 5.4 units on a scale STANDARD_DEVIATION 3 | 4.9 units on a scale STANDARD_DEVIATION 3.1 |
| Brief Pain Inventory: severity score | 4.7 units on a scale STANDARD_DEVIATION 2.5 | 4.6 units on a scale STANDARD_DEVIATION 2.5 | 4.6 units on a scale STANDARD_DEVIATION 2.5 |
| Clinical Global Patient Impression Score (patient-rated) | -0.6 units on a scale STANDARD_DEVIATION 1.1 | -0.7 units on a scale STANDARD_DEVIATION 1.1 | -0.6 units on a scale STANDARD_DEVIATION 1.1 |
| Diabetes type 1 or type 2, No. Do not have diabetes type 1 or type 2 | 39 participants | 50 participants | 89 participants |
| Diabetes type 1 or type 2, No. Have diabetes type 1 or type 2 | 24 participants | 13 participants | 37 participants |
| Diastolic blood pressure | 73.6 mmHg STANDARD_DEVIATION 11.6 | 75.0 mmHg STANDARD_DEVIATION 11.3 | 74.3 mmHg STANDARD_DEVIATION 11.4 |
| Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Bloating severity | 2.2 units on a scale STANDARD_DEVIATION 1.4 | 2.6 units on a scale STANDARD_DEVIATION 1.1 | 2.4 units on a scale STANDARD_DEVIATION 1.2 |
| Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Early satiety severity | 2.6 units on a scale STANDARD_DEVIATION 1.1 | 2.7 units on a scale STANDARD_DEVIATION 0.9 | 2.6 units on a scale STANDARD_DEVIATION 1 |
| Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Excessive fullness severity | 2.7 units on a scale STANDARD_DEVIATION 1.1 | 2.8 units on a scale STANDARD_DEVIATION 0.9 | 2.7 units on a scale STANDARD_DEVIATION 1 |
| Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): GCSI total score | 2.2 units on a scale STANDARD_DEVIATION 0.9 | 2.3 units on a scale STANDARD_DEVIATION 0.7 | 2.3 units on a scale STANDARD_DEVIATION 0.8 |
| Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Nausea | 9.0 hours of nausea STANDARD_DEVIATION 7 | 9.3 hours of nausea STANDARD_DEVIATION 7.1 | 9.2 hours of nausea STANDARD_DEVIATION 7.1 |
| Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Nausea severity | 2.6 units on a scale STANDARD_DEVIATION 0.8 | 2.6 units on a scale STANDARD_DEVIATION 0.8 | 2.6 units on a scale STANDARD_DEVIATION 0.8 |
| Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Overall symptom severity | 2.5 units on a scale STANDARD_DEVIATION 0.8 | 2.6 units on a scale STANDARD_DEVIATION 0.7 | 2.6 units on a scale STANDARD_DEVIATION 0.8 |
| Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Retching (No. episodes) | 2.0 number of episodes STANDARD_DEVIATION 2.5 | 2.3 number of episodes STANDARD_DEVIATION 2.8 | 2.1 number of episodes STANDARD_DEVIATION 2.6 |
| Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Upper abdominal pain severity | 2.3 units on a scale STANDARD_DEVIATION 1.2 | 2.3 units on a scale STANDARD_DEVIATION 1 | 2.3 units on a scale STANDARD_DEVIATION 1.1 |
| Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Vomiting (No. episodes) | 1.3 number of episodes STANDARD_DEVIATION 1.6 | 1.1 number of episodes STANDARD_DEVIATION 1.5 | 1.2 number of episodes STANDARD_DEVIATION 1.5 |
| Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Vomiting severity | 1.0 units on a scale STANDARD_DEVIATION 1 | 0.9 units on a scale STANDARD_DEVIATION 1 | 1.0 units on a scale STANDARD_DEVIATION 1 |
| Medications in past month: antiemetic Did not take medication | 19 participants | 14 participants | 33 participants |
| Medications in past month: antiemetic Took medication | 44 participants | 49 participants | 93 participants |
| Medications in past month: benzodiazepine or anxiolytic Did not take medication | 50 participants | 36 participants | 86 participants |
| Medications in past month: benzodiazepine or anxiolytic Took medication | 13 participants | 27 participants | 40 participants |
| Medications in past month: narcotic Did not take medication | 57 participants | 59 participants | 116 participants |
| Medications in past month: narcotic Took medication | 6 participants | 4 participants | 10 participants |
| Medications in past month: neuropathic or pain modulator... Did not take medication | 36 participants | 34 participants | 70 participants |
| Medications in past month: neuropathic or pain modulator... Took medication | 27 participants | 29 participants | 56 participants |
| Medications in past month: other antidepressant Did not take medication | 51 participants | 53 participants | 104 participants |
| Medications in past month: other antidepressant Took medication | 12 participants | 10 participants | 22 participants |
| Medications in past month: prokinetic Did not take medication | 38 participants | 45 participants | 83 participants |
| Medications in past month: prokinetic Took medication | 25 participants | 18 participants | 43 participants |
| Medications in past month: proton pump inhibitors Did not take medication | 21 participants | 12 participants | 33 participants |
| Medications in past month: proton pump inhibitors Took medication | 42 participants | 51 participants | 93 participants |
| Medications in past month: selective serotonin reuptake inhibitors (SSRI) Did not take medication | 54 participants | 45 participants | 99 participants |
| Medications in past month: selective serotonin reuptake inhibitors (SSRI) Took medication | 9 participants | 18 participants | 27 participants |
| Medications in past month: tricyclic antidepressant (TCA) Did not take medication | 52 participants | 47 participants | 99 participants |
| Medications in past month: tricyclic antidepressant (TCA) Took medication | 11 participants | 16 participants | 27 participants |
| PAGI-SYM Severity index: Bloating subscore | 3.3 units on a scale STANDARD_DEVIATION 1.4 | 3.4 units on a scale STANDARD_DEVIATION 1.4 | 3.4 units on a scale STANDARD_DEVIATION 1.4 |
| PAGI-SYM Severity index: Constipation severity | 2.9 units on a scale STANDARD_DEVIATION 1.7 | 2.6 units on a scale STANDARD_DEVIATION 1.8 | 2.8 units on a scale STANDARD_DEVIATION 1.8 |
| PAGI-SYM Severity index: Diarrhea severity | 1.6 units on a scale STANDARD_DEVIATION 1.7 | 1.8 units on a scale STANDARD_DEVIATION 1.7 | 1.7 units on a scale STANDARD_DEVIATION 1.7 |
| PAGI-SYM Severity index: Fullness/early satiety subscore | 3.7 units on a scale STANDARD_DEVIATION 1 | 3.7 units on a scale STANDARD_DEVIATION 0.8 | 3.7 units on a scale STANDARD_DEVIATION 0.9 |
| PAGI-SYM Severity index: Gastroesophageal Reflux (GERD) subscore | 2.4 units on a scale STANDARD_DEVIATION 1.4 | 2.3 units on a scale STANDARD_DEVIATION 1.4 | 2.3 units on a scale STANDARD_DEVIATION 1.4 |
| PAGI-SYM Severity index: Gastroparesis Cardinal Symptom Index (GCSI), total score | 3.4 units on a scale STANDARD_DEVIATION 0.9 | 3.3 units on a scale STANDARD_DEVIATION 0.7 | 3.4 units on a scale STANDARD_DEVIATION 0.8 |
| PAGI-SYM Severity index: Lower abdominal discomfort | 2.5 units on a scale STANDARD_DEVIATION 1.6 | 2.6 units on a scale STANDARD_DEVIATION 1.4 | 2.6 units on a scale STANDARD_DEVIATION 1.5 |
| PAGI-SYM Severity index: Lower abdominal pain | 2.4 units on a scale STANDARD_DEVIATION 1.6 | 2.5 units on a scale STANDARD_DEVIATION 1.4 | 2.5 units on a scale STANDARD_DEVIATION 1.5 |
| PAGI-SYM Severity index: Nausea severity | 4.2 units on a scale STANDARD_DEVIATION 0.8 | 4.0 units on a scale STANDARD_DEVIATION 0.9 | 4.1 units on a scale STANDARD_DEVIATION 0.9 |
| PAGI-SYM Severity index: Nausea/vomiting predominant symptom, No. Nausea/vomiting not predominant symptom | 25 participants | 24 participants | 49 participants |
| PAGI-SYM Severity index: Nausea/vomiting predominant symptom, No. Nausea/vomiting predominant symptom | 38 participants | 39 participants | 77 participants |
| PAGI-SYM Severity index: Nausea/vomiting severity subscore | 3.3 units on a scale STANDARD_DEVIATION 1.1 | 2.8 units on a scale STANDARD_DEVIATION 0.9 | 3.0 units on a scale STANDARD_DEVIATION 1.1 |
| PAGI-SYM Severity index: Retching severity | 3.0 units on a scale STANDARD_DEVIATION 1.6 | 2.6 units on a scale STANDARD_DEVIATION 1.3 | 2.8 units on a scale STANDARD_DEVIATION 1.5 |
| PAGI-SYM Severity index: Upper abdominal pain subscore | 3.4 units on a scale STANDARD_DEVIATION 1.3 | 3.3 units on a scale STANDARD_DEVIATION 1.3 | 3.4 units on a scale STANDARD_DEVIATION 1.3 |
| PAGI-SYM Severity index: Vomiting severity | 2.6 units on a scale STANDARD_DEVIATION 1.8 | 1.9 units on a scale STANDARD_DEVIATION 1.6 | 2.2 units on a scale STANDARD_DEVIATION 1.7 |
| Race/Ethnicity, Customized Black | 8 participants | 2 participants | 10 participants |
| Race/Ethnicity, Customized Other | 2 participants | 2 participants | 4 participants |
| Race/Ethnicity, Customized White | 53 participants | 59 participants | 112 participants |
| Region of Enrollment United States | 63 participants | 63 participants | 126 participants |
| Scintigraphic gastric emptying (GES): Delayed gastric emptying, No. Do not have delayed gastric emptying | 34 participants | 20 participants | 54 participants |
| Scintigraphic gastric emptying (GES): Delayed gastric emptying, No. Have delayed gastric emptying | 29 participants | 43 participants | 72 participants |
| Scintigraphic gastric emptying (GES): Percent gastric retention at 1 hour | 69.7 percent retention STANDARD_DEVIATION 20 | 73.0 percent retention STANDARD_DEVIATION 19.3 | 71.3 percent retention STANDARD_DEVIATION 19.6 |
| Scintigraphic gastric emptying (GES): Percent gastric retention at 2 hours | 45.6 percent retention STANDARD_DEVIATION 24.9 | 53.1 percent retention STANDARD_DEVIATION 23.4 | 49.4 percent retention STANDARD_DEVIATION 24.4 |
| Scintigraphic gastric emptying (GES): Percent gastric retention at 4 hours | 17.8 percent retention STANDARD_DEVIATION 21.8 | 20.4 percent retention STANDARD_DEVIATION 17.5 | 19.1 percent retention STANDARD_DEVIATION 19.7 |
| Scintigraphic gastric emptying (GES): Rapid gastric emptying, No. Do not have rapid gastric emptying | 59 participants | 61 participants | 120 participants |
| Scintigraphic gastric emptying (GES): Rapid gastric emptying, No. Have rapid gastric emptying | 4 participants | 2 participants | 6 participants |
| Sex: Female, Male Female | 49 Participants | 52 Participants | 101 Participants |
| Sex: Female, Male Male | 14 Participants | 11 Participants | 25 Participants |
| SF-36 Quality of Life (QOL): Mental component summary score | 41.4 units on a scale STANDARD_DEVIATION 14.3 | 40.5 units on a scale STANDARD_DEVIATION 13.5 | 40.9 units on a scale STANDARD_DEVIATION 13.9 |
| SF-36 Quality of Life (QOL): Physical component summary score | 33.5 units on a scale STANDARD_DEVIATION 9.5 | 29.8 units on a scale STANDARD_DEVIATION 8.8 | 31.6 units on a scale STANDARD_DEVIATION 9.4 |
| State-Trait Anxiety Inventory: Severe trait anxiety, No. Do not have severe trait anxiety | 46 participants | 44 participants | 90 participants |
| State-Trait Anxiety Inventory: Severe trait anxiety, No. Have severe trait anxiety | 17 participants | 19 participants | 36 participants |
| State-Trait Anxiety Inventory (STAI): Severe state anxiety, No. Do not have severe state anxiety | 48 participants | 44 participants | 92 participants |
| State-Trait Anxiety Inventory (STAI): Severe state anxiety, No. Have severe state anxiety | 15 participants | 19 participants | 34 participants |
| State-Trait Anxiety Inventory (STAI): State anxiety score | 39.6 units on a scale STANDARD_DEVIATION 13.9 | 41.9 units on a scale STANDARD_DEVIATION 13.9 | 40.7 units on a scale STANDARD_DEVIATION 13.9 |
| State-Trait Anxiety Inventory (STAI): Trait anxiety score | 40.3 units on a scale STANDARD_DEVIATION 14.2 | 43.0 units on a scale STANDARD_DEVIATION 13.2 | 41.6 units on a scale STANDARD_DEVIATION 13.7 |
| Systolic blood pressure | 121.1 mmHg STANDARD_DEVIATION 17.8 | 122.1 mmHg STANDARD_DEVIATION 15 | 121.6 mmHg STANDARD_DEVIATION 16.4 |
| Waist circumference | 90.9 cm STANDARD_DEVIATION 17.2 | 91.3 cm STANDARD_DEVIATION 18 | 91.1 cm STANDARD_DEVIATION 17.5 |
| Waist to hip ratio | 0.9 ratio STANDARD_DEVIATION 0.1 | 0.9 ratio STANDARD_DEVIATION 0.1 | 0.9 ratio STANDARD_DEVIATION 0.1 |
| Weight | 75.4 kg STANDARD_DEVIATION 22.8 | 75.1 kg STANDARD_DEVIATION 20.6 | 75.2 kg STANDARD_DEVIATION 21.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 63 | 0 / 63 |
| other Total, other adverse events | 21 / 63 | 11 / 63 |
| serious Total, serious adverse events | 1 / 63 | 0 / 63 |
Outcome results
Primary
Number of Participants With Improvement in Nausea
The primary outcome measure is a binary (0,1) variable indicating improvement in nausea or not in the mean of available visual analog scale (VAS) scores over the 28 day treatment period compared to the mean of VAS scores during the 7 day baseline period. The criteria for improvement are either a 25 mm or more reduction in mean VAS or attaining a mean VAS during the treatment period of \< 25 mm.
Time frame: 4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aprepitant | Number of Participants With Improvement in Nausea | 29 participants |
| Aprepitant-placebo | Number of Participants With Improvement in Nausea | 25 participants |
Comparison: Either 1) improvement in mean of available nausea VAS scores over 28-day treatment period compared to means of VAS during the 7-day baseline (BL) period being ≤ -25 mm, or 2) mean VAS after 28-days of treatment was \< 25 mm.p-value: 0.4395% CI: [0.8, 1.7]Cochran-Mantel-Haenszel
Secondary
Beck Depression Inventory (BDI) Score
The Beck Depression Inventory (BDI) survey is comprised of 21 multiple choice questions that relate to depression, cognition, and physical well-being and is used to quantify depression. The BDI total score is the sum of the 21 items, where each item ranges from 0 to 3 (lower scores are less severe, higher scores are more severe). The range for the BDI total score is 0 to 63, where lower scores indicate less depression and higher scores indicate more severe depression. The outcome measure, change from baseline in BDI score, has a possible range from -63 to +63, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | Beck Depression Inventory (BDI) Score | -4.6 units on a scale | Standard Deviation 8.5 |
| Aprepitant-placebo | Beck Depression Inventory (BDI) Score | -2.4 units on a scale | Standard Deviation 5.9 |
p-value: 0.0995% CI: [-4.7, 0.4]ANCOVA
Secondary
Blood Urea Nitrogen (BUN)
Change from baseline in blood urea nitrogen (BUN) (mg/dL)
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | Blood Urea Nitrogen (BUN) | -0.9 mg/dL | Standard Deviation 4.6 |
| Aprepitant-placebo | Blood Urea Nitrogen (BUN) | -0.3 mg/dL | Standard Deviation 3.3 |
p-value: 0.4595% CI: [-2, 0.9]ANCOVA
Secondary
Brief Pain Inventory: Interference Score
The Brief Pain Inventory: Interference Score is the average of seven questions in which the participant rates the degree to which his or her pain interferes with daily functions and mood: general activity, mood, walking ability, normal work, relationships, sleep, enjoyment of life. The range of possible scores is 0 to 10, with higher scores indicating more interference caused by pain. The outcome measure, change from baseline in Brief Pain Inventory Interference Score, has a possible range from -10 to +10, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | Brief Pain Inventory: Interference Score | -1.1 units on a scale | Standard Deviation 2.6 |
| Aprepitant-placebo | Brief Pain Inventory: Interference Score | -1.0 units on a scale | Standard Deviation 2.6 |
p-value: 0.3895% CI: [-1.3, 0.5]ANCOVA
Secondary
Brief Pain Inventory: Severity Score
The Brief Pain Inventory: Severity Score is the average of four questions in which the participant rates his or her pain: the worse pain in the past 24 hours, the least pain in the past 24 hours, average pain, and pain right now. The range of possible scores is 0 to 10, with higher scores indicating more severe pain. The outcome measure, change from baseline in Brief Pain Inventory Severity Score, has a possible range from -10 to +10, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | Brief Pain Inventory: Severity Score | -1.0 units on a scale | Standard Deviation 2.6 |
| Aprepitant-placebo | Brief Pain Inventory: Severity Score | -0.7 units on a scale | Standard Deviation 2.3 |
p-value: 0.5395% CI: [-1.1, 0.6]ANCOVA
Secondary
Calcium
Change from baseline in calcium (mg/dL)
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | Calcium | -0.1 mg/dL | Standard Deviation 0.4 |
| Aprepitant-placebo | Calcium | -0.1 mg/dL | Standard Deviation 0.4 |
p-value: 0.7695% CI: [-0.1, 0.1]ANCOVA
Secondary
Carbon Dioxide
Change from baseline in carbon dioxide (mEg/L)
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | Carbon Dioxide | -0.4 mEq/L | Standard Deviation 2.5 |
| Aprepitant-placebo | Carbon Dioxide | 0.4 mEq/L | Standard Deviation 2.4 |
p-value: 0.0795% CI: [-1.5, 0]ANCOVA
Secondary
Chloride
Change from baseline in chloride (mEq/L)
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | Chloride | 0.6 mEq/L | Standard Deviation 3 |
| Aprepitant-placebo | Chloride | -0.2 mEq/L | Standard Deviation 2.9 |
p-value: 0.5395% CI: [-0.7, 1.3]ANCOVA
Secondary
Clinical Global Patient Impression Score (Patient-rated)
The Clinical Global Patient Impression Score quantifies the overall relief of the patient's symptom, by asking the participant to consider how they felt over the past week in regard to stomach symptoms and overall well-being, and rate relief of symptoms in comparison to how they felt before entering the study. Possible scores are: -3=very considerably worse, -2=considerably worse, -1=somewhat worse, 0=unchanged, 1=somewhat better, 2=considerably better, 3=completely better. The range of scores is -3 to 3, where higher scores are considered a better outcome. The outcome measure, change from baseline in Clinical Global Patient Impression Score, has a possible range of -6 to +6, with positive values indicating a better outcome (improvement) and negative values indicating a worse outcome.
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | Clinical Global Patient Impression Score (Patient-rated) | 1.3 units on a scale | Standard Deviation 1.4 |
| Aprepitant-placebo | Clinical Global Patient Impression Score (Patient-rated) | 1.0 units on a scale | Standard Deviation 1.4 |
p-value: 0.1795% CI: [-0.1, 0.7]ANCOVA
Secondary
Creatinine
Change from baseline in creatinine (mg/dL)
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | Creatinine | -0.1 mg/dL | Standard Deviation 0.2 |
| Aprepitant-placebo | Creatinine | 0.0 mg/dL | Standard Deviation 0.2 |
p-value: 0.00895% CI: [-0.2, 0]ANCOVA
Secondary
Electrogastrography (EGG): Bradygastria (1-<2.5 Cpm) at 4 Weeks, 0-30 Post-satiety Measurement
Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. The 0-30 post-satiety measurement of the test is that taken 30 minutes after the participant consumes Ensure until feeling completely full. Normal pacing is considered 2.5-3.7 cycles per minute (cpm). Bradygastria is when the rate of electrical activity in the stomach is \<2.5 cycles per minute for at least 1 minute. Average power in frequency region is the % of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (baseline refers to test performed during screening, not baseline value of the EGG test) in % of time with frequencies in the ranges. Negative values for bradygastria indicate improvement (less time in a dysrhythmic state).
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | Electrogastrography (EGG): Bradygastria (1-<2.5 Cpm) at 4 Weeks, 0-30 Post-satiety Measurement | 2.1 average power in frequency region, % | Standard Deviation 17.7 |
| Aprepitant-placebo | Electrogastrography (EGG): Bradygastria (1-<2.5 Cpm) at 4 Weeks, 0-30 Post-satiety Measurement | 0.5 average power in frequency region, % | Standard Deviation 19.4 |
p-value: 0.4795% CI: [-4.1, 8.9]ANCOVA
Secondary
Electrogastrography (EGG): Bradygastria (1-<2.5 Cpm) at 4 Weeks, Baseline Measurement
Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. Normal pacing is considered 2.5-3.7 cycles per minute (cpm). Bradygastria is when the rate of electrical activity in the stomach is \<2.5 cycles per minute for at least 1 minute (a decrease in electrical activity in the stomach). The average power in frequency region is the percentage of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (here, baseline refers to the test performed during screening, not the baseline value of the EGG test) in percent of time with frequencies in the ranges, where negative values for bradygastria indicate improvement (less time in a dysrhythmic state).
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | Electrogastrography (EGG): Bradygastria (1-<2.5 Cpm) at 4 Weeks, Baseline Measurement | -4.6 average power in frequency region, % | Standard Deviation 24.6 |
| Aprepitant-placebo | Electrogastrography (EGG): Bradygastria (1-<2.5 Cpm) at 4 Weeks, Baseline Measurement | 2.8 average power in frequency region, % | Standard Deviation 21.5 |
p-value: 0.2895% CI: [-12, 3.5]ANCOVA
Secondary
Electrogastrography (EGG): Duodenal (>10-15 Cpm) at 4 Weeks, 0-30 Post-satiety Measurement
Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. The 0-30 post-satiety measurement that taken 30 minutes after the participant consumes Ensure until feeling completely full. Normal pacing is considered 2.5-3.7 cycles per minute (cpm). Duodenal is when the rate of electrical activity in the stomach is \>10-15 cycles per minute for at least 1 minute. The average power in frequency region is the percentage of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (here, baseline refers to the test performed during screening, not the baseline value of the EGG test) in percent of time with frequencies in the ranges, where negative values for duodenal indicate improvement (less time in a dysrhythmic state).
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | Electrogastrography (EGG): Duodenal (>10-15 Cpm) at 4 Weeks, 0-30 Post-satiety Measurement | -0.8 average power in frequency region, % | Standard Deviation 7.3 |
| Aprepitant-placebo | Electrogastrography (EGG): Duodenal (>10-15 Cpm) at 4 Weeks, 0-30 Post-satiety Measurement | -0.5 average power in frequency region, % | Standard Deviation 5.5 |
p-value: 0.3495% CI: [-2.6, 1]ANCOVA
Secondary
Electrogastrography (EGG): Duodenal (>10-15 Cpm) at 4 Weeks, Baseline Measurement
Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. Normal pacing is considered 2.5-3.7 cycles per minute (cpm). Duodenal is when the rate of electrical activity in the stomach is \>10-15 cycles per minute for at least 1 minute. The average power in frequency region is the percentage of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (here, baseline refers to the test performed during screening, not the baseline value of the EGG test) in percent of time with frequencies in the ranges, where negative values for duodenal indicate improvement (less time in a dysrhythmic state).
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week followup visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | Electrogastrography (EGG): Duodenal (>10-15 Cpm) at 4 Weeks, Baseline Measurement | 2.1 average power in frequency region, % | Standard Deviation 13.5 |
| Aprepitant-placebo | Electrogastrography (EGG): Duodenal (>10-15 Cpm) at 4 Weeks, Baseline Measurement | -0.2 average power in frequency region, % | Standard Deviation 13.4 |
p-value: 0.5795% CI: [-3.4, 6.1]ANCOVA
Secondary
Electrogastrography (EGG): Normogastria (2.5-<3.8 Cpm) at 4 Weeks, 0-30 Post-satiety Measurement
Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. The 0-30 post-satiety measurement that taken 30 minutes after the participant consumes Ensure until feeling completely full. Normal pacing (normogastria) is considered 2.5-3.7 cycles per minute (cpm). The average power in frequency region is the percentage of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (baseline refers to the test performed during screening, not the baseline value of the EGG test) in percent of time with frequencies in the ranges, where positive values for normal rates indicate an increase in the normal pacing (improvement).
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | Electrogastrography (EGG): Normogastria (2.5-<3.8 Cpm) at 4 Weeks, 0-30 Post-satiety Measurement | 1.0 average power in frequency region, % | Standard Deviation 15.8 |
| Aprepitant-placebo | Electrogastrography (EGG): Normogastria (2.5-<3.8 Cpm) at 4 Weeks, 0-30 Post-satiety Measurement | 0.8 average power in frequency region, % | Standard Deviation 15.1 |
p-value: 0.4895% CI: [-3.6, 7.6]ANCOVA
Secondary
Electrogastrography (EGG): Normogastria (2.5-<3.8 Cpm) at 4 Weeks, Baseline Measurement
Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. Normal pacing (normogastria) is considered 2.5-3.7 cycles per minute (cpm). The average power in frequency region is the percentage of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (here, baseline refers to the test performed during screening, not the baseline value of the EGG test) in percent of time with frequencies in the ranges, where positive values for normal rates indicate an increase in the normal pacing (improvement).
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | Electrogastrography (EGG): Normogastria (2.5-<3.8 Cpm) at 4 Weeks, Baseline Measurement | 1.0 average power in frequency region, % | Standard Deviation 19.9 |
| Aprepitant-placebo | Electrogastrography (EGG): Normogastria (2.5-<3.8 Cpm) at 4 Weeks, Baseline Measurement | -1.0 average power in frequency region, % | Standard Deviation 16.5 |
p-value: 0.6895% CI: [-4.5, 6.9]ANCOVA
Secondary
Electrogastrography (EGG): Tachygastria (3.8-10 Cpm) at 4 Weeks, 0-30 Post-satiety Measurement
Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. The 0-30 post-satiety measurement that taken 30 minutes after the participant consumes Ensure until feeling completely full. Normal pacing is considered 2.5-3.7 cycles per minute (cpm). Tachygastria is when the rate of electrical activity in the stomach is 3.8-10 cycles per minute for at least 1 minute (an increase in electrical activity in the stomach). The average power in frequency region is the percentage of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (here, baseline refers to the test performed during screening, not the baseline value of the EGG test) in percent of time with frequencies in the ranges, where negative values for tachygastria indicate improvement (less time in a dysrhythmic state).
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | Electrogastrography (EGG): Tachygastria (3.8-10 Cpm) at 4 Weeks, 0-30 Post-satiety Measurement | -2.1 average power in frequency region, % | Standard Deviation 9.7 |
| Aprepitant-placebo | Electrogastrography (EGG): Tachygastria (3.8-10 Cpm) at 4 Weeks, 0-30 Post-satiety Measurement | -0.8 average power in frequency region, % | Standard Deviation 14.1 |
p-value: 0.0195% CI: [-8.5, -1.2]ANCOVA
Secondary
Electrogastrography (EGG): Tachygastria (3.8-10 Cpm) at 4 Weeks, Baseline Measurement
Electrogastrography (EGG) is a test which records the electrical pacemaking signals that travel through the stomach muscles and control the muscles' contractions. Normal pacing is considered 2.5-3.7 cycles per minute (cpm). Tachygastria is when the rate of electrical activity in the stomach is 3.8-10 cycles per minute for at least 1 minute (an increase in electrical activity in the stomach). The average power in frequency region is the percentage of time that the dominant EGG frequencies are in a given frequency: bradygastria, normal, tachygastria, or duodenal. The outcome measure is the change from baseline (here, baseline refers to the test performed during screening, not the baseline value of the EGG test) in percent of time with frequencies in the ranges, where negative values for tachygastria indicate improvement (less time in a dysrhythmic state).
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | Electrogastrography (EGG): Tachygastria (3.8-10 Cpm) at 4 Weeks, Baseline Measurement | 1.5 average power in frequency region, % | Standard Deviation 12.3 |
| Aprepitant-placebo | Electrogastrography (EGG): Tachygastria (3.8-10 Cpm) at 4 Weeks, Baseline Measurement | -1.6 average power in frequency region, % | Standard Deviation 12 |
p-value: 0.4395% CI: [-2.2, 5.1]ANCOVA
Secondary
Gastrointestinal Symptom Rating Scale (GSRS): Abdominal Pain Score
The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item questionnaire for participants with gastrointestinal discomfort. The GSRS Abdominal Pain Score is a measure of how bothered the participant has been by pain or discomfort in the upper abdomen or pit of the stomach during the past week. The range of scores is 0 to 7, where 0 indicates no discomfort and 7 indicates very severe discomfort. Higher scores are considered a worse outcome.The outcome measure, change from baseline in GSRS Abdominal Pain Score, has a possible range from -7 to +7, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time frame: 4 week
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | Gastrointestinal Symptom Rating Scale (GSRS): Abdominal Pain Score | -1.3 units on a scale | Standard Deviation 1.1 |
| Aprepitant-placebo | Gastrointestinal Symptom Rating Scale (GSRS): Abdominal Pain Score | -0.7 units on a scale | Standard Deviation 1 |
p-value: 0.00195% CI: [-1, -0.2]ANCOVA
Secondary
Gastrointestinal Symptom Rating Scale (GSRS): Constipation Score
The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item questionnaire for participants with gastrointestinal discomfort. The GSRS Constipation Score is a measure of how bothered the participant has been by constipation during the past week. The range of scores is 0 to 7, where 0 indicates no discomfort and 7 indicates very severe discomfort. Higher scores are considered a worse outcome.The outcome measure, change from baseline in GSRS Constipation Score, has a possible range from -7 to +7, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | Gastrointestinal Symptom Rating Scale (GSRS): Constipation Score | -0.8 units on a scale | Standard Deviation 1.3 |
| Aprepitant-placebo | Gastrointestinal Symptom Rating Scale (GSRS): Constipation Score | -0.4 units on a scale | Standard Deviation 1.5 |
p-value: 0.0895% CI: [-0.9, 0.1]ANCOVA
Secondary
Gastrointestinal Symptom Rating Scale (GSRS): Diarrhea Score
The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item questionnaire for participants with gastrointestinal discomfort. The GSRS Diarrhea Score is a measure of how bothered the participant has been by diarrhea during the past week. The range of scores is 0 to 7, where 0 indicates no discomfort and 7 indicates very severe discomfort. Higher scores are considered a worse outcome.The outcome measure, change from baseline in GSRS Diarrhea Score, has a possible range from -7 to +7, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | Gastrointestinal Symptom Rating Scale (GSRS): Diarrhea Score | -0.5 units on a scale | Standard Deviation 1.6 |
| Aprepitant-placebo | Gastrointestinal Symptom Rating Scale (GSRS): Diarrhea Score | 0.1 units on a scale | Standard Deviation 1.3 |
p-value: 0.0595% CI: [-1, 0]ANCOVA
Secondary
Gastrointestinal Symptom Rating Scale (GSRS): Indigestion Score
The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item questionnaire for participants with gastrointestinal discomfort. The GSRS Indigestion Score is a measure of how bothered the participant has been by indigestion during the past week. The range of scores is 0 to 7, where 0 indicates no discomfort and 7 indicates very severe discomfort. Higher scores are considered a worse outcome.The outcome measure, change from baseline in GSRS Indigestion Score, has a possible range from -7 to +7, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time frame: 4 weeks
Population: The small number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | Gastrointestinal Symptom Rating Scale (GSRS): Indigestion Score | -0.7 units on a scale | Standard Deviation 1.3 |
| Aprepitant-placebo | Gastrointestinal Symptom Rating Scale (GSRS): Indigestion Score | -0.7 units on a scale | Standard Deviation 1.1 |
p-value: 0.2895% CI: [-0.6, 0.2]ANCOVA
Secondary
Gastrointestinal Symptom Rating Scale (GSRS): Reflux Score
The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item questionnaire for participants with gastrointestinal discomfort. The GSRS Reflux Score is a measure of how bothered the participant has been by acid reflux during the past week. The range of scores is 0 to 7, where 0 indicates no discomfort and 7 indicates very severe discomfort. Higher scores are considered a worse outcome.The outcome measure, change from baseline in GSRS Reflux Score, has a possible range from -7 to +7, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | Gastrointestinal Symptom Rating Scale (GSRS): Reflux Score | -1.1 units on a scale | Standard Deviation 1.5 |
| Aprepitant-placebo | Gastrointestinal Symptom Rating Scale (GSRS): Reflux Score | -0.7 units on a scale | Standard Deviation 1.6 |
p-value: 0.0695% CI: [-0.9, 0]ANCOVA
Secondary
Gastrointestinal Symptom Rating Scale (GSRS): Total Score
The Gastrointestinal Symptom Rating Scale (GSRS) is a 15-item questionnaire for participants with gastrointestinal discomfort. The GSRS Total Score is the average of the 15 items. Each item is rated on a 0 to 7 scale, where 0 indicates no discomfort and 7 indicates very severe discomfort. The range of scores is 0 to 7, where higher scores are considered a worse outcome.The outcome measure, change from baseline in GSRS Total Score, has a possible range from -7 to +7, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | Gastrointestinal Symptom Rating Scale (GSRS): Total Score | -0.8 units on a scale | Standard Deviation 0.9 |
| Aprepitant-placebo | Gastrointestinal Symptom Rating Scale (GSRS): Total Score | -0.5 units on a scale | Standard Deviation 0.9 |
p-value: 0.00795% CI: [-0.7, 0.1]ANCOVA
Secondary
Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Bloating Severity
Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Bloating Severity is the participant's assessment of bloating (feeling like you need to loosen your clothes) during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Bloating Severity, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Bloating Severity | -0.6 units on a scale | Standard Deviation 1 |
| Aprepitant-placebo | Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Bloating Severity | -0.4 units on a scale | Standard Deviation 0.8 |
p-value: 0.1295% CI: [-0.5, 0.1]ANCOVA
Secondary
Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Early Satiety Severity
Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Early Satiety Severity is the participant's assessment of early satiety (not able to finish normal-size meal) during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Early Satiety Severity, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Early Satiety Severity | 0.1 units on a scale | Standard Deviation 0.2 |
| Aprepitant-placebo | Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Early Satiety Severity | 0.08 units on a scale | Standard Deviation 0.3 |
p-value: 0.5195% CI: [-0.1, 0.1]ANCOVA
Secondary
Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Excessive Fullness Severity
Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Excessive Fullness Severity is the participant's assessment of excessive fullness (feeling excessively full after meals) during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Excessive Fullness Severity, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Excessive Fullness Severity | -0.6 units on a scale | Standard Deviation 0.9 |
| Aprepitant-placebo | Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Excessive Fullness Severity | -0.4 units on a scale | Standard Deviation 0.7 |
p-value: 0.2295% CI: [-0.4, 0.1]ANCOVA
Secondary
Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): GCSI Total Score
The Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): GCSI total score is the average of 3 subscores: Nausea (average of two items: nausea and vomiting), Early Satiety (average of two items: not able to finish normal size meal and feeling excessively full after meals), and Bloating (feeling like you need to loosen your clothes). Each item is the participant's assessment of severity of the symptom during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in GCSI total score, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): GCSI Total Score | -0.5 units on a scale | Standard Deviation 0.9 |
| Aprepitant-placebo | Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): GCSI Total Score | -0.4 units on a scale | Standard Deviation 0.5 |
p-value: 0.2295% CI: [-0.4, 0.1]ANCOVA
Secondary
Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Nausea (Hours)
Measure Description: Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Nausea is the participant's assessment of the number of hours of nausea experienced in the past 24 hours. The range is 0 to 24 hours. The outcome measure, change from baseline in number of hours of nausea, has a possible range from -24 to +24, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Nausea (Hours) | -2.5 hours of nausea | Standard Deviation 3.2 |
| Aprepitant-placebo | Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Nausea (Hours) | -1.2 hours of nausea | Standard Deviation 4.3 |
p-value: 0.0395% CI: [-2.8, -0.1]ANCOVA
Secondary
Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Nausea Severity
Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Nausea severity is the participant's assessment of nausea (feeling sick to your stomach as if you were going to vomit or throw up) during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in GCSI score, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Nausea Severity | -0.8 units on a scale | Standard Deviation 1 |
| Aprepitant-placebo | Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Nausea Severity | -0.5 units on a scale | Standard Deviation 0.7 |
p-value: 0.0695% CI: [-0.6, 0]ANCOVA
Secondary
Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Overall Symptom Severity
Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Overall Symptom Severity is the participant's assessment of overall severity of gastroparesis symptoms during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome, change from baseline in Overall Symptom Severity score, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Overall Symptom Severity | -0.7 units on a scale | Standard Deviation 0.8 |
| Aprepitant-placebo | Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Overall Symptom Severity | -0.4 units on a scale | Standard Deviation 0.6 |
p-value: 0.0295% CI: [-0.6, -0.1]ANCOVA
Secondary
Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Retching (No. Episodes)
Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Retching is the participant's assessment of the number of episodes of retching (heaving as if to vomit, but nothing comes up) experienced in the past 24 hours. The outcome is the change from baseline in the number of retching episodes, where negative numbers indicate improvement in retching frequency, and positive numbers indicate worsening in retching frequency.
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Retching (No. Episodes) | -0.5 number of episodes | Standard Deviation 1.5 |
| Aprepitant-placebo | Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Retching (No. Episodes) | -0.7 number of episodes | Standard Deviation 2 |
p-value: 0.7395% CI: [-0.4, 0.6]ANCOVA
Secondary
Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Upper Abdominal Pain Severity
Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Upper Abdominal Pain Severity is the participant's assessment of upper abdominal pain (above the navel) during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Upper Abdominal Pain Severity, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Upper Abdominal Pain Severity | -0.7 units on a scale | Standard Deviation 0.9 |
| Aprepitant-placebo | Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Upper Abdominal Pain Severity | -0.3 units on a scale | Standard Deviation 0.7 |
p-value: 0.0195% CI: [-0.7, -0.1]ANCOVA
Secondary
Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Vomiting (No. Episodes)
Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Vomiting is the participant's assessment of the number of episodes of vomiting experienced in the past 24 hours. The outcome is the change from baseleine in number of times vomited, where negative numbers indicate improvement in vomiting frequency, and positive numbers indicate worsening in vomiting frequency.
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Vomiting (No. Episodes) | -0.5 number of episodes | Standard Deviation 1 |
| Aprepitant-placebo | Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Vomiting (No. Episodes) | -0.4 number of episodes | Standard Deviation 1.1 |
p-value: 0.9495% CI: [-0.3, 0.3]ANCOVA
Secondary
Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Vomiting Severity
Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Vomiting Severity is the participant's assessment of vomiting during the past 24 hours, where 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. The range of scores is 0 to 4, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Vomiting Severity, has a possible range from -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Vomiting Severity | -0.4 units on a scale | Standard Deviation 0.8 |
| Aprepitant-placebo | Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD): Vomiting Severity | -0.2 units on a scale | Standard Deviation 0.5 |
p-value: 0.2495% CI: [-0.3, 0.1]ANCOVA
Secondary
Glucose
Change from baseline in glucose (mg/dL)
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | Glucose | 9.6 mg/dL | Standard Deviation 66.8 |
| Aprepitant-placebo | Glucose | 7.0 mg/dL | Standard Deviation 44.8 |
p-value: 0.7795% CI: [-18, 24.2]ANCOVA
Secondary
Hematocrit
Change from baseline in hematocrit
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | Hematocrit | -0.4 percentage RBCs | Standard Deviation 2.7 |
| Aprepitant-placebo | Hematocrit | -0.4 percentage RBCs | Standard Deviation 1.9 |
p-value: 0.7795% CI: [-0.7, 0.9]ANCOVA
Secondary
Hemoglobin
Change from baseline in hemoglobin (g/dL)
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | Hemoglobin | -0.1 g/dL | Standard Deviation 0.9 |
| Aprepitant-placebo | Hemoglobin | -0.2 g/dL | Standard Deviation 0.6 |
p-value: 0.4495% CI: [-0.2, 0.4]ANCOVA
Secondary
Hemoglobin A1c (HbA1c)
Change from baseline in hemoglobin A1c (HbA1c) (%)
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | Hemoglobin A1c (HbA1c) | -0.1 percent glycosylated hemoglobin | Standard Deviation 1 |
| Aprepitant-placebo | Hemoglobin A1c (HbA1c) | 0.1 percent glycosylated hemoglobin | Standard Deviation 0.5 |
p-value: 0.9795% CI: [-0.5, 0.5]ANCOVA
Secondary
Liver Enzymes and Proteins: Alanine Aminotransferase (ALT)
Change from baseline in serum alanine aminotransferase (ALT), U/L
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | Liver Enzymes and Proteins: Alanine Aminotransferase (ALT) | 2.3 U/L | Standard Deviation 36.6 |
| Aprepitant-placebo | Liver Enzymes and Proteins: Alanine Aminotransferase (ALT) | 0.8 U/L | Standard Deviation 7.6 |
p-value: 0.5995% CI: [-7, 12.2]ANCOVA
Secondary
Liver Enzymes and Proteins: Albumin
Change from baseline in albumin (g/dL)
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | Liver Enzymes and Proteins: Albumin | -0.1 g/dL | Standard Deviation 0.4 |
| Aprepitant-placebo | Liver Enzymes and Proteins: Albumin | -0.1 g/dL | Standard Deviation 0.4 |
p-value: 0.4695% CI: [-0.2, 0.1]ANCOVA
Secondary
Liver Enzymes and Proteins: Aspartate Aminotransferase (AST)
Change from baseline in aspartate aminotransferase (AST), U/L
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | Liver Enzymes and Proteins: Aspartate Aminotransferase (AST) | 3.1 U/L | Standard Deviation 30.2 |
| Aprepitant-placebo | Liver Enzymes and Proteins: Aspartate Aminotransferase (AST) | 0.9 U/L | Standard Deviation 7.7 |
p-value: 0.6195% CI: [-5.9, 10]ANCOVA
Secondary
Liver Enzymes and Proteins: Total Protein
Change from baseline in total protein (g/dL)
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | Liver Enzymes and Proteins: Total Protein | 0.0 g/dL | Standard Deviation 0.4 |
| Aprepitant-placebo | Liver Enzymes and Proteins: Total Protein | -0.1 g/dL | Standard Deviation 0.4 |
p-value: 0.2395% CI: [-0.1, 0.2]ANCOVA
Secondary
Magnesium
Change from baseline in magnesium (mg/dL)
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | Magnesium | 0.0 mg/dL | Standard Deviation 0.2 |
| Aprepitant-placebo | Magnesium | -0.0 mg/dL | Standard Deviation 0.2 |
p-value: 0.1895% CI: [0, 0.1]ANCOVA
Secondary
PAGI-SYM Severity: Bitter Taste Severity
The PAGI-SYM Severity index: Bitter Taste severity is the participant's assessment of bitter, acid, or sour taste in mouth during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Bitter Taste Severity score, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | PAGI-SYM Severity: Bitter Taste Severity | -0.8 units on a scale | Standard Deviation 1.6 |
| Aprepitant-placebo | PAGI-SYM Severity: Bitter Taste Severity | -0.5 units on a scale | Standard Deviation 1.3 |
p-value: 0.195% CI: [-0.8, 0.1]ANCOVA
Secondary
PAGI-SYM Severity Index: Bloating Severity
The PAGI-SYM Severity index: Bloating Severity is the participant's assessment of bloating (feel like you need to loosen your clothes) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Bloating Severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | PAGI-SYM Severity Index: Bloating Severity | -1.2 units on a scale | Standard Deviation 1.4 |
| Aprepitant-placebo | PAGI-SYM Severity Index: Bloating Severity | -0.5 units on a scale | Standard Deviation 1.3 |
p-value: 0.00195% CI: [-1.2, -0.3]ANCOVA
Secondary
PAGI-SYM Severity Index: Bloating Subscore
The PAGI-SYM Severity index: Bloating Subscore is the average of 2 items: bloating (feeling like you need to loosen your clothes) and stomach visibly larger. Each item is the participant's assessment of severity of the symptom during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The outcome measure, change from baseline in Bloating Subscore, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | PAGI-SYM Severity Index: Bloating Subscore | -1.2 units on a scale | Standard Deviation 1.2 |
| Aprepitant-placebo | PAGI-SYM Severity Index: Bloating Subscore | -0.6 units on a scale | Standard Deviation 1.2 |
p-value: 0.00495% CI: [-1.2, -0.2]ANCOVA
Secondary
PAGI-SYM Severity Index: Chest Discomfort During Sleep Time Severity
The PAGI-SYM Severity index: Chest discomfort during sleep severity is the participant's assessment of feeling of discomfort inside the chest at night (during sleep time) over the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Chest Discomfort During Sleep Time severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | PAGI-SYM Severity Index: Chest Discomfort During Sleep Time Severity | -0.9 units on a scale | Standard Deviation 1.5 |
| Aprepitant-placebo | PAGI-SYM Severity Index: Chest Discomfort During Sleep Time Severity | -0.6 units on a scale | Standard Deviation 1.4 |
p-value: 0.1795% CI: [-7, 0.1]ANCOVA
Secondary
PAGI-SYM Severity Index: Chest Discomfort During the Day Severity
The PAGI-SYM Severity index: Chest discomfort during the day severity is the participant's assessment of feeling of discomfort inside the chest during the day over the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Chest Discomfort During the Day severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | PAGI-SYM Severity Index: Chest Discomfort During the Day Severity | -1.1 units on a scale | Standard Deviation 1.5 |
| Aprepitant-placebo | PAGI-SYM Severity Index: Chest Discomfort During the Day Severity | -0.7 units on a scale | Standard Deviation 1.4 |
p-value: 0.0995% CI: [-0.8, 0.1]ANCOVA
Secondary
PAGI-SYM Severity Index: Constipation Severity
The PAGI-SYM Severity index: Constipation severity is the participant's assessment of constipation during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Constipation Severity score, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | PAGI-SYM Severity Index: Constipation Severity | -0.8 units on a scale | Standard Deviation 1.6 |
| Aprepitant-placebo | PAGI-SYM Severity Index: Constipation Severity | -0.3 units on a scale | Standard Deviation 1.5 |
p-value: 0.1395% CI: [-0.9, 0.1]ANCOVA
Secondary
PAGI-SYM Severity Index: Diarrhea Severity
The PAGI-SYM Severity index: Diarrhea severity is the participant's assessment of constipation during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Diarrhea Severity score, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | PAGI-SYM Severity Index: Diarrhea Severity | -0.1 units on a scale | Standard Deviation 1.4 |
| Aprepitant-placebo | PAGI-SYM Severity Index: Diarrhea Severity | -0.2 units on a scale | Standard Deviation 1.3 |
p-value: 0.9895% CI: [-0.5, 0.4]ANCOVA
Secondary
PAGI-SYM Severity Index: Excessive Fullness Severity
PAGI-SYM Severity index: Excessive fullness severity is the participant's assessment of feeling excessively full after meals during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Excessive Fullness severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | PAGI-SYM Severity Index: Excessive Fullness Severity | -1.1 units on a scale | Standard Deviation 1.4 |
| Aprepitant-placebo | PAGI-SYM Severity Index: Excessive Fullness Severity | -0.6 units on a scale | Standard Deviation 1.2 |
p-value: 0.0595% CI: [-0.9, 0]ANCOVA
Secondary
PAGI-SYM Severity Index: Fullness/Early Satiety Subscore
The PAGI-SYM Severity index: Fullness/Early Satiety Subscore is the average of 4 items: stomach fullness, not able to finish normal size meal, felling excessively full after meals, and loss of appetite. Each item is the participant's assessment of severity of the symptom during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Fullness/Early Satiety Subscore, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | PAGI-SYM Severity Index: Fullness/Early Satiety Subscore | -1.0 units on a scale | Standard Deviation 1.3 |
| Aprepitant-placebo | PAGI-SYM Severity Index: Fullness/Early Satiety Subscore | -0.7 units on a scale | Standard Deviation 1 |
p-value: 0.1395% CI: [-0.7, 0.1]ANCOVA
Secondary
PAGI-SYM Severity Index: Gastroparesis Cardinal Symptom Index (GCSI) Score
PAGI-SYM Severity index: Gastroparesis Cardinal Symptom Index (GCSI) score is the average of 3 subscores: Nausea (average of 3 items: nausea, retching, and vomiting), Fullness/Early Satiety (average of 4 items: stomach fullness, not able to finish normal size meal, feeling excessively full after meals, and loss of appetite), and Bloating (average if 2 items: bloating and stomach visibly larger). Each item is the participant's assessment of severity of the symptom during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The outcome measure, change from baseline in GCSI score, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | PAGI-SYM Severity Index: Gastroparesis Cardinal Symptom Index (GCSI) Score | -1.3 units on a scale | Standard Deviation 1 |
| Aprepitant-placebo | PAGI-SYM Severity Index: Gastroparesis Cardinal Symptom Index (GCSI) Score | -0.7 units on a scale | Standard Deviation 0.9 |
p-value: 0.00195% CI: [-0.9, -0.3]ANCOVA
Secondary
PAGI-SYM Severity Index: GERD Subscore
PAGI-SYM Severity index: Gastroesophageal Reflux (GERD) Subscore is the average of 7 items (heartburn during day, heartburn lying down, chest discomfort day, chest discomfort during sleep, regurgitation during day, regurgitation lying down, bitter taste in mouth). Each item is the participant's assessment of severity of the symptom, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in GERD Subscore, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | PAGI-SYM Severity Index: GERD Subscore | -1.1 units on a scale | Standard Deviation 1.3 |
| Aprepitant-placebo | PAGI-SYM Severity Index: GERD Subscore | -0.6 units on a scale | Standard Deviation 0.9 |
p-value: 0.00795% CI: [-0.8, -0.1]ANCOVA
Secondary
PAGI-SYM Severity Index: Heartburn During the Day Severity
The PAGI-SYM Severity index: Heartburn during the day severity is the participant's assessment of heartburn (burning pain rising in your chest or throat) during the day over the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Heartburn During the Day severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | PAGI-SYM Severity Index: Heartburn During the Day Severity | -1.2 units on a scale | Standard Deviation 1.5 |
| Aprepitant-placebo | PAGI-SYM Severity Index: Heartburn During the Day Severity | -0.6 units on a scale | Standard Deviation 1.4 |
p-value: 0.0295% CI: [-1, -0.1]ANCOVA
Secondary
PAGI-SYM Severity Index: Heartburn When Lying Down Severity
The PAGI-SYM Severity index: Heartburn when lying down severity is the participant's assessment of heartburn (burning pain rising in your chest or throat) when lying down over the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Heartburn When Lying Down severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | PAGI-SYM Severity Index: Heartburn When Lying Down Severity | -1.2 units on a scale | Standard Deviation 1.5 |
| Aprepitant-placebo | PAGI-SYM Severity Index: Heartburn When Lying Down Severity | -0.7 units on a scale | Standard Deviation 1.4 |
p-value: 0.0695% CI: [-0.9, 0]ANCOVA
Secondary
PAGI-SYM Severity Index: Loss of Appetite Severity
PAGI-SYM Severity index: Loss of appetite severity is the participant's assessment of loss of appetite during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Loss of appetite severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | PAGI-SYM Severity Index: Loss of Appetite Severity | -0.9 units on a scale | Standard Deviation 1.6 |
| Aprepitant-placebo | PAGI-SYM Severity Index: Loss of Appetite Severity | -0.9 units on a scale | Standard Deviation 1.4 |
p-value: 0.7295% CI: [-0.4, 0.6]ANCOVA
Secondary
PAGI-SYM Severity Index: Lower Abdominal Discomfort Severity
The PAGI-SYM Severity index: Lower Abdominal Discomfort severity is the participant's assessment of lower abdominal discomfort (below the navel) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Lower Abdominal Discomfort severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | PAGI-SYM Severity Index: Lower Abdominal Discomfort Severity | -1.1 units on a scale | Standard Deviation 1.4 |
| Aprepitant-placebo | PAGI-SYM Severity Index: Lower Abdominal Discomfort Severity | -0.6 units on a scale | Standard Deviation 1.5 |
p-value: 0.0495% CI: [-0.9, 0]ANCOVA
Secondary
PAGI-SYM Severity Index: Lower Abdominal Pain Severity
The PAGI-SYM Severity index: Lower Abdominal Pain severity is the participant's assessment of lower abdominal pain (below the navel) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Lower Abdominal Pain severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | PAGI-SYM Severity Index: Lower Abdominal Pain Severity | -0.8 units on a scale | Standard Deviation 1.4 |
| Aprepitant-placebo | PAGI-SYM Severity Index: Lower Abdominal Pain Severity | -0.6 units on a scale | Standard Deviation 1.5 |
p-value: 0.1995% CI: [-0.8, 0.2]ANCOVA
Secondary
PAGI-SYM Severity Index: Nausea Severity
The PAGI-SYM Severity index: Nausea severity is the participant's assessment of nausea (feeling sick to your stomach as if you were going to vomit or throw up) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Nausea Severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | PAGI-SYM Severity Index: Nausea Severity | -1.8 units on a scale | Standard Deviation 1.5 |
| Aprepitant-placebo | PAGI-SYM Severity Index: Nausea Severity | -1.0 units on a scale | Standard Deviation 1.4 |
p-value: 0.00595% CI: [-1.3, -0.2]ANCOVA
Secondary
PAGI-SYM Severity Index: Nausea/Vomiting Severity Subscore
The PAGI-SYM Severity index: Nausea/vomiting severity subscore is the average of 3 items: nausea, retching, and vomiting. Each item is the participant's assessment of severity of the symptom during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Nausea/vomiting severity subscore, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | PAGI-SYM Severity Index: Nausea/Vomiting Severity Subscore | -1.7 units on a scale | Standard Deviation 1.3 |
| Aprepitant-placebo | PAGI-SYM Severity Index: Nausea/Vomiting Severity Subscore | -0.7 units on a scale | Standard Deviation 1.1 |
p-value: <0.00195% CI: [-1.2, -0.4]ANCOVA
Secondary
PAGI-SYM Severity Index: Regurgitation During the Day Severity
The PAGI-SYM Severity index: Regurgitation during the day severity is the participant's assessment of regurgitation or reflux (fluid or liquid from your stomach coming up into throat) during the day over the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Regurgitation During the Day severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | PAGI-SYM Severity Index: Regurgitation During the Day Severity | -1.2 units on a scale | Standard Deviation 1.7 |
| Aprepitant-placebo | PAGI-SYM Severity Index: Regurgitation During the Day Severity | -0.5 units on a scale | Standard Deviation 1.5 |
p-value: 0.00995% CI: [-1.1, -0.2]ANCOVA
Secondary
PAGI-SYM Severity Index: Regurgitation When Lying Down Severity
The PAGI-SYM Severity index: Regurgitation when lying down severity is the participant's assessment of regurgitation or reflux (fluid or liquid from your stomach coming up into throat) when lying down over the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Regurgitation When Lying Down severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | PAGI-SYM Severity Index: Regurgitation When Lying Down Severity | -1.3 units on a scale | Standard Deviation 1.7 |
| Aprepitant-placebo | PAGI-SYM Severity Index: Regurgitation When Lying Down Severity | -0.5 units on a scale | Standard Deviation 1.3 |
p-value: 0.00495% CI: [-1.2, -0.2]ANCOVA
Secondary
PAGI-SYM Severity Index: Retching Severity
The PAGI-SYM Severity index: Retching Severity is the participant's assessment of retching (heaving as if to vomit, but nothing comes up) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Retching Severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | PAGI-SYM Severity Index: Retching Severity | -1.7 units on a scale | Standard Deviation 1.6 |
| Aprepitant-placebo | PAGI-SYM Severity Index: Retching Severity | -0.8 units on a scale | Standard Deviation 1.4 |
p-value: 0.00395% CI: [-2.3, -0.3]ANCOVA
Secondary
PAGI-SYM Severity Index: Stomach Distention Severity
The PAGI-SYM Severity index: Stomach distention severity is the participant's assessment of stomach distention (stomach or belly visibly larger) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Stomach Distention severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | PAGI-SYM Severity Index: Stomach Distention Severity | -1.1 units on a scale | Standard Deviation 1.3 |
| Aprepitant-placebo | PAGI-SYM Severity Index: Stomach Distention Severity | -0.7 units on a scale | Standard Deviation 1.3 |
p-value: 0.0495% CI: [-0.9, 0]ANCOVA
Secondary
PAGI-SYM Severity Index: Stomach Fullness Severity
PAGI-SYM Severity index: Stomach Fullness severity is the participant's assessment of stomach fullness during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Stomach Fullness severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | PAGI-SYM Severity Index: Stomach Fullness Severity | -1.1 units on a scale | Standard Deviation 1.6 |
| Aprepitant-placebo | PAGI-SYM Severity Index: Stomach Fullness Severity | -0.5 units on a scale | Standard Deviation 1.4 |
p-value: 0.0395% CI: [-1, -0.1]ANCOVA
Secondary
PAGI-SYM Severity Index: Unable to Finish Meal Severity
PAGI-SYM Severity index: Unable to Finish Meal severity is the participant's assessment of being unable to finish a normal size meal during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Unable to Finish Meal severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | PAGI-SYM Severity Index: Unable to Finish Meal Severity | -0.8 units on a scale | Standard Deviation 1.4 |
| Aprepitant-placebo | PAGI-SYM Severity Index: Unable to Finish Meal Severity | -0.6 units on a scale | Standard Deviation 1.3 |
p-value: 0.1695% CI: [-0.8, 0.1]ANCOVA
Secondary
PAGI-SYM Severity Index: Upper Abdominal Discomfort Severity
The PAGI-SYM Severity index: Upper Abdominal Discomfort severity is the participant's assessment of upper abdominal discomfort (above the navel) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Upper Abdominal Discomfort severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | PAGI-SYM Severity Index: Upper Abdominal Discomfort Severity | -1.2 units on a scale | Standard Deviation 1.6 |
| Aprepitant-placebo | PAGI-SYM Severity Index: Upper Abdominal Discomfort Severity | -0.7 units on a scale | Standard Deviation 1.3 |
p-value: 0.0795% CI: [-1, 0]ANCOVA
Secondary
PAGI-SYM Severity Index: Upper Abdominal Pain Severity
The PAGI-SYM Severity index: Upper Abdominal Pain severity is the participant's assessment of upper abdominal pain (above the navel) during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Upper Abdominal Pain severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | PAGI-SYM Severity Index: Upper Abdominal Pain Severity | -1.0 units on a scale | Standard Deviation 1.6 |
| Aprepitant-placebo | PAGI-SYM Severity Index: Upper Abdominal Pain Severity | -0.5 units on a scale | Standard Deviation 1.4 |
p-value: 0.1495% CI: [-0.9, 0.1]ANCOVA
Secondary
PAGI-SYM Severity Index: Upper Abdominal Pain Subscore
The PAGI-SYM Severity index: Upper Abdominal Pain subscore is the average of 2 items (upper abdominal pain, upper abdominal discomfort). Each item is the participant's assessment of severity of the symptom during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Upper Abdominal Pain Subscore, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | PAGI-SYM Severity Index: Upper Abdominal Pain Subscore | -1.1 units on a scale | Standard Deviation 1.5 |
| Aprepitant-placebo | PAGI-SYM Severity Index: Upper Abdominal Pain Subscore | -0.6 units on a scale | Standard Deviation 1.2 |
p-value: 0.0895% CI: [-0.9, 0.1]ANCOVA
Secondary
PAGI-SYM Severity Index: Vomiting Severity
The PAGI-SYM Severity index: Vomiting Severity is the participant's assessment of vomiting during the past 24 hours, where 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, and 5=very severe. The range of scores is 0 to 5, where higher scores are considered a worse outcome. The outcome measure, change from baseline in Vomiting Severity, has a possible range from -5 to +5, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | PAGI-SYM Severity Index: Vomiting Severity | -1.6 units on a scale | Standard Deviation 1.7 |
| Aprepitant-placebo | PAGI-SYM Severity Index: Vomiting Severity | -0.5 units on a scale | Standard Deviation 1.4 |
p-value: 0.00195% CI: [-1.1, -0.3]ANCOVA
Secondary
Platelet Count
Change from baseline in platelet count
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | Platelet Count | -7.3 x10^3 cells/microliter | Standard Deviation 47.1 |
| Aprepitant-placebo | Platelet Count | 4.8 x10^3 cells/microliter | Standard Deviation 38.5 |
p-value: 0.1795% CI: [-26.5, 4.7]ANCOVA
Secondary
Potassium
Change from baseline in potassium (mEq/L)
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | Potassium | 0.1 mEq/L | Standard Deviation 0.5 |
| Aprepitant-placebo | Potassium | 0.0 mEq/L | Standard Deviation 0.4 |
p-value: 0.5295% CI: [-1, 0.2]ANCOVA
Secondary
Red Blood Cell Count (RBC)
Change from baseline in red blood cell count (RBC)
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | Red Blood Cell Count (RBC) | -0.1 x10^6 cells/microliter | Standard Deviation 0.3 |
| Aprepitant-placebo | Red Blood Cell Count (RBC) | -0.1 x10^6 cells/microliter | Standard Deviation 0.2 |
p-value: 0.8895% CI: [-0.1, 0.1]ANCOVA
Secondary
Satiety Test, Volume Consumed
The Satiety Test measures the total volume of liquid (Ensure) that the participant is able to consume. The participant drinks 150 mL of Ensure every 5 minutes until he/she is completely full. The outcome measure is the change from baseline in volume of liquid (Ensure) consumed (mL), where positive values indicate a positive outcome (improvement).
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Aprepitant | Satiety Test, Volume Consumed | -13.0 mL |
| Aprepitant-placebo | Satiety Test, Volume Consumed | 9.2 mL |
p-value: 0.495% CI: [-70.5, 28.1]ANCOVA
Secondary
Sodium
Change from baseline in sodium (mEq/L)
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | Sodium | -0.3 mEq/L | Standard Deviation 2.3 |
| Aprepitant-placebo | Sodium | -0.7 mEq/L | Standard Deviation 2.9 |
p-value: 0.9395% CI: [-0.9, 1]ANCOVA
Secondary
State-Trait Anxiety Inventory (STAI): State Anxiety Score
The State-Trait Anxiety Inventory (STAI): State anxiety score is the sum of scores from 20 questions relating to state anxiety, which is a temporary state varying in intensity. The possible range of scores is from 20 to 80, with increasing scores considered a worse outcome. The outcome measure, change from baseline in STAI State Anxiety score, has a possible range from -60 to +60, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | State-Trait Anxiety Inventory (STAI): State Anxiety Score | -3.1 units on a scale | Standard Deviation 8.7 |
| Aprepitant-placebo | State-Trait Anxiety Inventory (STAI): State Anxiety Score | -1.7 units on a scale | Standard Deviation 10.6 |
p-value: 0.2895% CI: [-5.2, 1.5]ANCOVA
Secondary
State-Trait Anxiety Inventory (STAI): Trait Anxiety Score
The State-Trait Anxiety Inventory (STAI): Trait anxiety score is the sum of scores from 20 questions pertaining to trait anxiety, which is a general propensity to be anxious. The possible range of scores is from 20 to 80, with increasing scores considered a worse outcome. The outcome measure, change from baseline in STAI Trait Anxiety score, has a possible range from -60 to +60, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | State-Trait Anxiety Inventory (STAI): Trait Anxiety Score | -1.8 units on a scale | Standard Deviation 8.8 |
| Aprepitant-placebo | State-Trait Anxiety Inventory (STAI): Trait Anxiety Score | -0.7 units on a scale | Standard Deviation 8.4 |
p-value: 0.395% CI: [-4.6, 1.4]ANCOVA
Secondary
White Blood Cell Count (WBC)
Change from baseline in white blood cell count (WBC)
Time frame: 4 weeks
Population: The smaller number of participants analyzed is due to missing data at the 4-week follow-up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aprepitant | White Blood Cell Count (WBC) | -0.3 x10^9 cells/L | Standard Deviation 1.5 |
| Aprepitant-placebo | White Blood Cell Count (WBC) | -0.3 x10^9 cells/L | Standard Deviation 1.8 |
p-value: 0.895% CI: [-0.6, 0.5]ANCOVA