Diabetic Gastroparesis
Conditions
Keywords
Diabetes, Gastroparesis, Delayed gastric emptying, Nausea, Vomiting, Bloating, Abdominal pain, Early Satiety, Gastric stasis, Gastropathy
Brief summary
The purpose of this study is evaluate the safety and efficacy of Metoclopramide Nasal Spray compared to placebo in reducing the symptoms of diabetic gastroparesis in adult men.
Detailed description
Diabetic men with clinical symptoms attributed to diabetic gastroparesis and documentation of delayed gastric emptying who meet the protocol-specified entry criteria will be randomized to Metoclopramide Nasal Spray 10 mg or placebo administered as a single intranasal spray four (4) times daily; 30 minutes before meals and at bedtime for a total of four (4) weeks.
Interventions
One 10 mg spray dose 30 minutes before meals and before bed for 28 days (QID)
DRUGPlacebo Nasal Spray
One placebo spray dose 30 minutes before meals and before bed for 28 days (QID)
Sponsors
Evoke Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male subjects between the ages of 18 and 75 years * Willingness and ability to give written informed consent * The ability to read, understand and speak English * Prior diagnosis of Type 1 or Type 2 diabetes * Diagnosis of diabetic gastroparesis with confirmation of delayed gastric emptying * A mean daily gastroparesis symptom score of ≥1.4 and ≤3.5 prior to randomization * Willingness to discontinue current treatment for diabetic gastroparesis and to avoid all proscribed (excluded) medications, as specified by the protocol, for the duration of the study
Exclusion criteria
* Gastric bypass, gastric banding, gastric pacemaker, post surgical causes of gastroparesis and disorders known to be associated with abnormal gastrointestinal motility * A history of allergic or adverse responses, including, but not limited to, acute dystonic reactions and tardive dyskinesia, to metoclopramide or any comparable or similar product * A history of, or physical findings suggestive of, tardive dyskinesia * A history of epilepsy or currently using and unwilling or unable stop other drugs known to be associated with extrapyramidal reactions at screening * Malignancy (with the exception of treated squamous cell or basal cell carcinoma of the skin) currently present, initially diagnosed or recurring within five (5) years of screening * Renal dysfunction calculated as creatinine clearance (CrCl) \<40 mL/min at screening * Hemoglobin A1c \>11.5% at screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gastroparesis Symptom Assessment (GSA), a Patient Reported Outcome Measure | Change from the Baseline Period to Week 4 in Daily Total Score (Intent-to Treat Population) | Change from the Baseline Period to Week 4 of the Treatment Period in the mean daily Gastroparesis Symptom Assessment (GSA) total score for subjects receiving Metoclopramide Nasal Spray 10 mg versus subjects receiving placebo. The GSA minimum value is 0 (no symptoms) and the maximum value is 4 (very severe symptoms). A higher score is a worse outcome. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Metoclopramide Nasal Spray Metoclopramide Nasal Spray 10 mg, 30 minutes before meals and at bedtime (QID) for 4 weeks
Metoclopramide Nasal Spray: One 10 mg spray dose 30 minutes before meals and before bed for 28 days (QID) | 26 |
| Placebo Nasal Spray Placebo Nasal Spray 30 minutes before meals and at bedtime (QID) for 4 weeks
Placebo Nasal Spray: One placebo spray dose 30 minutes before meals and before bed for 28 days (QID) | 27 |
| Total | 53 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Metoclopramide Nasal Spray | Total | Placebo Nasal Spray |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 5 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants | 48 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 9 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants | 44 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Gastroparesis Symptom Assessment | 2.096 units on a scale STANDARD_DEVIATION 0.4801 | 2.167 units on a scale STANDARD_DEVIATION 0.4468 | 2.235 units on a scale STANDARD_DEVIATION 0.4097 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 9 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 19 Participants | 41 Participants | 22 Participants |
| Region of Enrollment United States | 26 participants | 53 participants | 27 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 26 Participants | 53 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 27 |
| other Total, other adverse events | 7 / 26 | 3 / 27 |
| serious Total, serious adverse events | 0 / 26 | 3 / 27 |
Outcome results
Primary
Gastroparesis Symptom Assessment (GSA), a Patient Reported Outcome Measure
Change from the Baseline Period to Week 4 of the Treatment Period in the mean daily Gastroparesis Symptom Assessment (GSA) total score for subjects receiving Metoclopramide Nasal Spray 10 mg versus subjects receiving placebo. The GSA minimum value is 0 (no symptoms) and the maximum value is 4 (very severe symptoms). A higher score is a worse outcome.
Time frame: Change from the Baseline Period to Week 4 in Daily Total Score (Intent-to Treat Population)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Metoclopramide Nasal Spray | Gastroparesis Symptom Assessment (GSA), a Patient Reported Outcome Measure | -0.751 score on a scale | Standard Deviation 0.4673 |
| Placebo Nasal Spray | Gastroparesis Symptom Assessment (GSA), a Patient Reported Outcome Measure | -0.657 score on a scale | Standard Deviation 0.9042 |
p-value: 0.597ANCOVA