Gastroesophageal Reflux Disease
Conditions
Keywords
Gastroesophageal Reflux Disease
Brief summary
The purpose of this study is to determine the long-term safety profile of daily treatment with dexlansoprazole MR in subjects with gastroesophageal reflux disease.
Detailed description
This open-label study is intended to determine the long-term safety profile of dexlansoprazole MR over 12 months of dosing with 60 mg once-daily (QD) or 90 mg QD in subjects with gastroesophageal reflux disease (GERD), including those with esophageal erosions. Prior to a protocol amendment, 300 subjects successfully completed one of the symptomatic nonerosive gastroesophageal reflux studies T-GD04-082 (NCT00251745) or T-GD04-083 (NCT00251758) in which they were randomly assigned to receive placebo or dexlansoprazole MR 60 or 90 mg QD. Subjects who were enrolled from one of these symptomatic GERD studies were randomly assigned in a 1:1 ratio to receive either dexlansoprazole MR 60 or 90 mg QD in this long-term study. After implementation of protocol amendment #4, an additional 300 subjects with gastroesophageal reflux disease including those with erosive esophagitis will be enrolled and treated with dexlansoprazole MR 90 mg QD for 12 months. Approximately 200 study sites in the U.S. will participate. For all analyses involving visits during treatment from subjects enrolled prior to protocol amendment #4, baseline refers to pretreatment to Study T-GD04-082 (NCT00251745) or T-GD04-083 (NCT00251758). For subjects enrolled under protocol amendment #4, baseline is based on screening or predosing measurement.
Interventions
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 12 months.
Sponsors
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects must have successfully completed either T-GD04-082 (NCT00251745) or T-GD04-083 (NCT00251758) or have a diagnosis of gastroesophageal reflux disease with or without erosive esophagitis.
Exclusion criteria
* Any condition that may require inpatient surgery during the course of the study. * Use of prescription or non-prescription proton pump inhibitors, histamine (H2) receptor antagonists, sucralfate, misoprostol or prokinetics throughout the study. * Use of antacids \[except for study supplied Gelusil®\]. * Subjects using drugs with significant anticholinergic effects such as tricyclics who cannot stay on a stable dose for 4 weeks prior to dosing and throughout the study. * Evidence of uncontrolled systemic disease. * Allergy to any proton pump inhibitor including Prilosec, Nexium, Prevacid, or others, any component of dexlansoprazole MR, or Gelusil/antacid. * Need to take blood thinners. * Need to take more than 12 doses of non-steroidal anti-inflammatory drugs per month. * Had cancer (except basal cell cancer of the skin) within 3 years prior to screening. * Has other esophageal disease including Barrett's esophagus or strictures requiring dilation. * Has had radiation or cryotherapy to the esophagus. * Has active gastric or duodenal ulcers within 4 weeks of starting study drug. * Has a history of hypersecretory conditions such as Zollinger Ellison Syndrome. * History of alcohol abuse. * Has acquired immunodeficiency syndrome. * Has had acute upper gastrointestinal bleeding within 4 weeks of endoscopy. * Received a blood product transfusion within 3 months of taking the first dose of study drug. * Has previously participated in another dexlansoprazole MR long-term treatment clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes From Baseline to Final Visit in Fundus Biopsy Results | Baseline and Final Visit (up to 12 months) | Normal=normal tissue; Unknown Baseline = Baseline biopsy not available; Abnormal diagnoses include: Reactive Gastropathy, Chronic Gastritis, Intestinal Metaplasia, Reflective Observation Mucosa-Associated Lymphoid Tissue Lymphoma, Other Abnormal. |
| Mean Change From Baseline to Month 12 for Inorganic Phosphorus Values | Baseline and Month 12 | — |
| Mean Change From Baseline to Month 12 for Total Bilirubin Values | Baseline and Month 12 | — |
| Mean Change From Baseline to Month 12 for Alkaline Phosphatase Values | Baseline and Month 12 | — |
| Mean Change From Baseline to Month 12 for Aspartate Aminotransferase Values | Baseline and Month 12 | — |
| Mean Change From Baseline to Month 12 for Alanine Aminotransferase Values | Baseline and Month 12 | — |
| Mean Change From Baseline to Month 12 for Serum Gastrin Levels | Baseline and Month 12 | — |
| Mean Change From Baseline to Month 12 for Systolic Blood Pressure | Baseline and Month 12 | — |
| Mean Change From Baseline to Month 12 for Diastolic Blood Pressure | Baseline and Month 12 | — |
| Mean Change From Baseline to Month 12 for Pulse Rate | Baseline and Month 12 | — |
| Changes From Baseline to Final Visit in Antrum Biopsy Results | Baseline and Final Visit (up to 12 months) | Normal=normal tissue; Unknown Baseline = Baseline biopsy not available; Abnormal diagnoses include: Reactive Gastropathy, Chronic Gastritis, Intestinal Metaplasia, Reflective Observation Mucosa-Associated Lymphoid Tissue Lymphoma, Other Abnormal. |
| Mean Change From Baseline to Month 12 for Hemoglobin Values | Baseline and Month 12 | — |
| Mean Change From Baseline to Month 12 for Hematocrit Values | Baseline and Month 12 | Hematocrit measurement percent is the absolute difference in Hematocrit values, and not percentage difference. |
| Mean Change From Baseline to Month 12 for Red Blood Cell Count Values | Baseline and Month 12 | — |
| Mean Change From Baseline to Month 12 for Mean Corpuscular Hemoglobin Concentration Values | Baseline and Month 12 | — |
| Mean Change From Baseline to Month 12 for Platelet Count Values | Baseline and Month 12 | — |
| Mean Change From Baseline to Month 12 for White Blood Cell Count Values | Baseline and Month 12 | — |
| Mean Change From Baseline to Month 12 for Blood Urea Nitrogen Values | Baseline and Month 12 | — |
| Mean Change From Baseline to Month 12 for Creatinine Values | Baseline and Month 12 | — |
| Mean Change From Baseline to Month 12 for Calcium Values | Baseline and Month 12 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline to Month 3 for PAGI-QOL Total Score | Baseline and Month 3 | Mean overall composite QOL score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL. |
| Mean Change From Baseline to Month 6 for PAGI-QOL Total Score | Baseline and Month 6 | Mean overall composite QOL score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL. |
| Mean Change From Baseline to Month 9 for PAGI-QOL Total Score | Baseline and Month 9 | Mean overall composite QOL score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL. |
| Mean Change From Baseline to Month 12 for PAGI-QOL Total Score | Baseline and Month 12 | Mean overall composite QOL score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL. |
| Mean Change From Baseline to Month 1 for PAGI-SYM Total Score | Baseline and Month 1 | Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity). |
| Mean Change From Baseline to Month 3 for PAGI-SYM Total Score | Baseline and Month 3 | Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity). |
| Mean Change From Baseline to Month 6 for PAGI-SYM Total Score | Baseline and Month 6 | Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity). |
| Mean Change From Baseline to Month 9 for PAGI-SYM Total Score | Baseline and Month 9 | Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity). |
| Mean Change From Baseline to Month 12 for PAGI-SYM Total Score | Baseline and Month 12 | Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity). |
| Mean Change From Baseline to Month 1 for PAGI-QOL Total Score | Baseline and Month 1 | Mean overall composite Quality of Life (QOL) score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL. |
Countries
United States
Participant flow
Recruitment details
Subjects were enrolled at 104 sites in the United States from 07 January 2006 to 25 June 2008.
Pre-assignment details
At screening, subjects completed a Patient Assessment of Upper Gastrointestinal Disorders Quality-of-Life Index (PAGI-QOL) and Patient Assessment of Upper Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) questionnaires before enrollment in Dexlansoprazole Modified Release (MR) 60 mg or 90 mg once daily (QD) treatment groups.
Participants by arm
| Arm | Count |
|---|---|
| Dexlansoprazole MR 60 mg QD Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months | 153 |
| Dexlansoprazole MR 90 mg QD Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months | 438 |
| Total | 591 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 17 | 36 |
| Overall Study | Erosive esophagitis not healed | 0 | 20 |
| Overall Study | Inclusion/Exclusion criteria not met | 0 | 1 |
| Overall Study | Lost to Follow-up | 10 | 27 |
| Overall Study | Protocol Violation | 2 | 2 |
| Overall Study | Various | 4 | 23 |
| Overall Study | Withdrew Consent | 17 | 48 |
Baseline characteristics
| Characteristic | Dexlansoprazole MR 90 mg QD | Dexlansoprazole MR 60 mg QD | Total |
|---|---|---|---|
| Age, Continuous | 49.0 years STANDARD_DEVIATION 13.5 | 47.8 years STANDARD_DEVIATION 13.78 | 48.7 years STANDARD_DEVIATION 13.57 |
| Age, Customized 45 to <65 years | 237 subjects | 71 subjects | 308 subjects |
| Age, Customized <45 years | 158 subjects | 65 subjects | 223 subjects |
| Age, Customized ≥65 years | 43 subjects | 17 subjects | 60 subjects |
| Ethnicity (NIH/OMB) Hispanic or Latino | 64 Participants | 24 Participants | 88 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 374 Participants | 129 Participants | 503 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 8 subjects | 3 subjects | 11 subjects |
| Race/Ethnicity, Customized Asian | 14 subjects | 6 subjects | 20 subjects |
| Race/Ethnicity, Customized Black of African Heritage | 44 subjects | 18 subjects | 62 subjects |
| Race/Ethnicity, Customized Multiracial | 6 subjects | 0 subjects | 6 subjects |
| Race/Ethnicity, Customized White | 366 subjects | 126 subjects | 492 subjects |
| Region of Enrollment United States | 438 subjects | 153 subjects | 591 subjects |
| Sex: Female, Male Female | 283 Participants | 105 Participants | 388 Participants |
| Sex: Female, Male Male | 155 Participants | 48 Participants | 203 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 63 / — | 165 / — |
| serious Total, serious adverse events | 9 / — | 21 / — |
Outcome results
Primary
Changes From Baseline to Final Visit in Antrum Biopsy Results
Normal=normal tissue; Unknown Baseline = Baseline biopsy not available; Abnormal diagnoses include: Reactive Gastropathy, Chronic Gastritis, Intestinal Metaplasia, Reflective Observation Mucosa-Associated Lymphoid Tissue Lymphoma, Other Abnormal.
Time frame: Baseline and Final Visit (up to 12 months)
Population: All subjects with Final Visit antrum biopsies are included. Each subject is counted only once per tissue type based on the worst diagnosis. Final Visit was the last visit of this study and no more than 14 days post-dosing.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dexlansoprazole MR 60 mg QD | Changes From Baseline to Final Visit in Antrum Biopsy Results | Normal Baseline to Abnormal Final Visit | 11 subjects |
| Dexlansoprazole MR 60 mg QD | Changes From Baseline to Final Visit in Antrum Biopsy Results | Abnormal Baseline to Normal Final Visit | 21 subjects |
| Dexlansoprazole MR 60 mg QD | Changes From Baseline to Final Visit in Antrum Biopsy Results | Normal Baseline to Normal Final Visit | 39 subjects |
| Dexlansoprazole MR 60 mg QD | Changes From Baseline to Final Visit in Antrum Biopsy Results | Abnormal Baseline to Abnormal Final Visit | 29 subjects |
| Dexlansoprazole MR 60 mg QD | Changes From Baseline to Final Visit in Antrum Biopsy Results | Unknown Baseline to Normal Final Visit | 1 subjects |
| Dexlansoprazole MR 60 mg QD | Changes From Baseline to Final Visit in Antrum Biopsy Results | Unknown Baseline to Abnormal Final Visit | 1 subjects |
| Dexlansoprazole MR 90 mg QD | Changes From Baseline to Final Visit in Antrum Biopsy Results | Unknown Baseline to Normal Final Visit | 11 subjects |
| Dexlansoprazole MR 90 mg QD | Changes From Baseline to Final Visit in Antrum Biopsy Results | Normal Baseline to Abnormal Final Visit | 61 subjects |
| Dexlansoprazole MR 90 mg QD | Changes From Baseline to Final Visit in Antrum Biopsy Results | Abnormal Baseline to Abnormal Final Visit | 60 subjects |
| Dexlansoprazole MR 90 mg QD | Changes From Baseline to Final Visit in Antrum Biopsy Results | Unknown Baseline to Abnormal Final Visit | 4 subjects |
| Dexlansoprazole MR 90 mg QD | Changes From Baseline to Final Visit in Antrum Biopsy Results | Normal Baseline to Normal Final Visit | 114 subjects |
| Dexlansoprazole MR 90 mg QD | Changes From Baseline to Final Visit in Antrum Biopsy Results | Abnormal Baseline to Normal Final Visit | 47 subjects |
Primary
Changes From Baseline to Final Visit in Fundus Biopsy Results
Normal=normal tissue; Unknown Baseline = Baseline biopsy not available; Abnormal diagnoses include: Reactive Gastropathy, Chronic Gastritis, Intestinal Metaplasia, Reflective Observation Mucosa-Associated Lymphoid Tissue Lymphoma, Other Abnormal.
Time frame: Baseline and Final Visit (up to 12 months)
Population: All subjects with Final Visit fundus biopsies are included. Each subject is counted only once per tissue type based on the worst diagnosis. Final Visit was the last visit of this study and no more than 14 days postdosing.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dexlansoprazole MR 60 mg QD | Changes From Baseline to Final Visit in Fundus Biopsy Results | Normal Baseline to Normal Final Visit | 55 subjects |
| Dexlansoprazole MR 60 mg QD | Changes From Baseline to Final Visit in Fundus Biopsy Results | Normal Baseline to Abnormal Final Visit | 8 subjects |
| Dexlansoprazole MR 60 mg QD | Changes From Baseline to Final Visit in Fundus Biopsy Results | Abnormal Baseline to Normal Final Visit | 17 subjects |
| Dexlansoprazole MR 60 mg QD | Changes From Baseline to Final Visit in Fundus Biopsy Results | Abnormal Baseline to Abnormal Final Visit | 21 subjects |
| Dexlansoprazole MR 60 mg QD | Changes From Baseline to Final Visit in Fundus Biopsy Results | Unknown Baseline to Normal Final Visit | 2 subjects |
| Dexlansoprazole MR 60 mg QD | Changes From Baseline to Final Visit in Fundus Biopsy Results | Unknown Baseline to Abnormal Final Visit | 0 subjects |
| Dexlansoprazole MR 90 mg QD | Changes From Baseline to Final Visit in Fundus Biopsy Results | Unknown Baseline to Normal Final Visit | 2 subjects |
| Dexlansoprazole MR 90 mg QD | Changes From Baseline to Final Visit in Fundus Biopsy Results | Normal Baseline to Normal Final Visit | 198 subjects |
| Dexlansoprazole MR 90 mg QD | Changes From Baseline to Final Visit in Fundus Biopsy Results | Abnormal Baseline to Abnormal Final Visit | 35 subjects |
| Dexlansoprazole MR 90 mg QD | Changes From Baseline to Final Visit in Fundus Biopsy Results | Normal Baseline to Abnormal Final Visit | 35 subjects |
| Dexlansoprazole MR 90 mg QD | Changes From Baseline to Final Visit in Fundus Biopsy Results | Unknown Baseline to Abnormal Final Visit | 3 subjects |
| Dexlansoprazole MR 90 mg QD | Changes From Baseline to Final Visit in Fundus Biopsy Results | Abnormal Baseline to Normal Final Visit | 33 subjects |
Primary
Mean Change From Baseline to Month 12 for Alanine Aminotransferase Values
Time frame: Baseline and Month 12
Population: All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexlansoprazole MR 60 mg QD | Mean Change From Baseline to Month 12 for Alanine Aminotransferase Values | 1.6 U/L | Standard Deviation 10.43 |
| Dexlansoprazole MR 90 mg QD | Mean Change From Baseline to Month 12 for Alanine Aminotransferase Values | 0.5 U/L | Standard Deviation 17.43 |
p-value: 0.601ANOVA
Primary
Mean Change From Baseline to Month 12 for Alkaline Phosphatase Values
Time frame: Baseline and Month 12
Population: All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexlansoprazole MR 60 mg QD | Mean Change From Baseline to Month 12 for Alkaline Phosphatase Values | 0.4 U/L | Standard Deviation 11.59 |
| Dexlansoprazole MR 90 mg QD | Mean Change From Baseline to Month 12 for Alkaline Phosphatase Values | -0.4 U/L | Standard Deviation 14.69 |
p-value: 0.673ANOVA
Primary
Mean Change From Baseline to Month 12 for Aspartate Aminotransferase Values
Time frame: Baseline and Month 12
Population: All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexlansoprazole MR 60 mg QD | Mean Change From Baseline to Month 12 for Aspartate Aminotransferase Values | 0.9 U/L | Standard Deviation 7.81 |
| Dexlansoprazole MR 90 mg QD | Mean Change From Baseline to Month 12 for Aspartate Aminotransferase Values | 0.6 U/L | Standard Deviation 10.14 |
p-value: 0.817ANOVA
Primary
Mean Change From Baseline to Month 12 for Blood Urea Nitrogen Values
Time frame: Baseline and Month 12
Population: All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexlansoprazole MR 60 mg QD | Mean Change From Baseline to Month 12 for Blood Urea Nitrogen Values | 0.1 mg/dL | Standard Deviation 4.58 |
| Dexlansoprazole MR 90 mg QD | Mean Change From Baseline to Month 12 for Blood Urea Nitrogen Values | 0.0 mg/dL | Standard Deviation 4.03 |
p-value: 0.843ANOVA
Primary
Mean Change From Baseline to Month 12 for Calcium Values
Time frame: Baseline and Month 12
Population: All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexlansoprazole MR 60 mg QD | Mean Change From Baseline to Month 12 for Calcium Values | -0.25 mg/dL | Standard Deviation 0.421 |
| Dexlansoprazole MR 90 mg QD | Mean Change From Baseline to Month 12 for Calcium Values | -0.04 mg/dL | Standard Deviation 0.443 |
p-value: <0.001ANOVA
Primary
Mean Change From Baseline to Month 12 for Creatinine Values
Time frame: Baseline and Month 12
Population: All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexlansoprazole MR 60 mg QD | Mean Change From Baseline to Month 12 for Creatinine Values | -0.04 mg/dL | Standard Deviation 0.323 |
| Dexlansoprazole MR 90 mg QD | Mean Change From Baseline to Month 12 for Creatinine Values | -0.04 mg/dL | Standard Deviation 0.111 |
p-value: 0.923ANOVA
Primary
Mean Change From Baseline to Month 12 for Diastolic Blood Pressure
Time frame: Baseline and Month 12
Population: All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexlansoprazole MR 60 mg QD | Mean Change From Baseline to Month 12 for Diastolic Blood Pressure | 4.0 mm Hg | Standard Deviation 9.53 |
| Dexlansoprazole MR 90 mg QD | Mean Change From Baseline to Month 12 for Diastolic Blood Pressure | 0.6 mm Hg | Standard Deviation 11.03 |
p-value: 0.011ANOVA
Primary
Mean Change From Baseline to Month 12 for Hematocrit Values
Hematocrit measurement percent is the absolute difference in Hematocrit values, and not percentage difference.
Time frame: Baseline and Month 12
Population: All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexlansoprazole MR 60 mg QD | Mean Change From Baseline to Month 12 for Hematocrit Values | -1.98 percentage | Standard Deviation 2.573 |
| Dexlansoprazole MR 90 mg QD | Mean Change From Baseline to Month 12 for Hematocrit Values | -0.93 percentage | Standard Deviation 3.156 |
p-value: 0.006ANOVA
Primary
Mean Change From Baseline to Month 12 for Hemoglobin Values
Time frame: Baseline and Month 12
Population: All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexlansoprazole MR 60 mg QD | Mean Change From Baseline to Month 12 for Hemoglobin Values | -0.29 g/dL | Standard Deviation 0.873 |
| Dexlansoprazole MR 90 mg QD | Mean Change From Baseline to Month 12 for Hemoglobin Values | -0.05 g/dL | Standard Deviation 0.959 |
p-value: 0.042ANOVA
Primary
Mean Change From Baseline to Month 12 for Inorganic Phosphorus Values
Time frame: Baseline and Month 12
Population: All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexlansoprazole MR 60 mg QD | Mean Change From Baseline to Month 12 for Inorganic Phosphorus Values | 0.09 mg/dL | Standard Deviation 0.613 |
| Dexlansoprazole MR 90 mg QD | Mean Change From Baseline to Month 12 for Inorganic Phosphorus Values | 0.06 mg/dL | Standard Deviation 0.73 |
p-value: 0.758ANOVA
Primary
Mean Change From Baseline to Month 12 for Mean Corpuscular Hemoglobin Concentration Values
Time frame: Baseline and Month 12
Population: All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexlansoprazole MR 60 mg QD | Mean Change From Baseline to Month 12 for Mean Corpuscular Hemoglobin Concentration Values | 0.67 g/dL | Standard Deviation 1.428 |
| Dexlansoprazole MR 90 mg QD | Mean Change From Baseline to Month 12 for Mean Corpuscular Hemoglobin Concentration Values | 0.56 g/dL | Standard Deviation 1.277 |
p-value: 0.494ANOVA
Primary
Mean Change From Baseline to Month 12 for Platelet Count Values
Time frame: Baseline and Month 12
Population: All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexlansoprazole MR 60 mg QD | Mean Change From Baseline to Month 12 for Platelet Count Values | -12.7 Platelet Count x10 to the 3/mcL | Standard Deviation 36.24 |
| Dexlansoprazole MR 90 mg QD | Mean Change From Baseline to Month 12 for Platelet Count Values | -1.9 Platelet Count x10 to the 3/mcL | Standard Deviation 39.31 |
p-value: 0.026ANOVA
Primary
Mean Change From Baseline to Month 12 for Pulse Rate
Time frame: Baseline and Month 12
Population: All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexlansoprazole MR 60 mg QD | Mean Change From Baseline to Month 12 for Pulse Rate | 0.5 beats per minute | Standard Deviation 10.11 |
| Dexlansoprazole MR 90 mg QD | Mean Change From Baseline to Month 12 for Pulse Rate | -1.3 beats per minute | Standard Deviation 11.87 |
p-value: 0.207ANOVA
Primary
Mean Change From Baseline to Month 12 for Red Blood Cell Count Values
Time frame: Baseline and Month 12
Population: All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexlansoprazole MR 60 mg QD | Mean Change From Baseline to Month 12 for Red Blood Cell Count Values | -0.31 Red Blood Cell count x10 to the 6/μL | Standard Deviation 0.271 |
| Dexlansoprazole MR 90 mg QD | Mean Change From Baseline to Month 12 for Red Blood Cell Count Values | -0.11 Red Blood Cell count x10 to the 6/μL | Standard Deviation 0.349 |
p-value: <0.001ANOVA
Primary
Mean Change From Baseline to Month 12 for Serum Gastrin Levels
Time frame: Baseline and Month 12
Population: All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexlansoprazole MR 60 mg QD | Mean Change From Baseline to Month 12 for Serum Gastrin Levels | 155.8 pg/mL | Standard Deviation 189.67 |
| Dexlansoprazole MR 90 mg QD | Mean Change From Baseline to Month 12 for Serum Gastrin Levels | 115.4 pg/mL | Standard Deviation 156.32 |
p-value: 0.065ANOVA
Primary
Mean Change From Baseline to Month 12 for Systolic Blood Pressure
Time frame: Baseline and Month 12
Population: All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexlansoprazole MR 60 mg QD | Mean Change From Baseline to Month 12 for Systolic Blood Pressure | 3.8 mm Hg | Standard Deviation 15.37 |
| Dexlansoprazole MR 90 mg QD | Mean Change From Baseline to Month 12 for Systolic Blood Pressure | 1.9 mm Hg | Standard Deviation 14.91 |
p-value: 0.319ANOVA
Primary
Mean Change From Baseline to Month 12 for Total Bilirubin Values
Time frame: Baseline and Month 12
Population: All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexlansoprazole MR 60 mg QD | Mean Change From Baseline to Month 12 for Total Bilirubin Values | -0.02 mg/dL | Standard Deviation 0.166 |
| Dexlansoprazole MR 90 mg QD | Mean Change From Baseline to Month 12 for Total Bilirubin Values | -0.01 mg/dL | Standard Deviation 0.17 |
p-value: 0.737ANOVA
Primary
Mean Change From Baseline to Month 12 for White Blood Cell Count Values
Time frame: Baseline and Month 12
Population: All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexlansoprazole MR 60 mg QD | Mean Change From Baseline to Month 12 for White Blood Cell Count Values | -0.20 White Blood Cell count x10 to the 3/mcL | Standard Deviation 1.61 |
| Dexlansoprazole MR 90 mg QD | Mean Change From Baseline to Month 12 for White Blood Cell Count Values | 0.04 White Blood Cell count x10 to the 3/mcL | Standard Deviation 1.624 |
p-value: 0.22ANOVA
Secondary
Mean Change From Baseline to Month 12 for PAGI-QOL Total Score
Mean overall composite QOL score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL.
Time frame: Baseline and Month 12
Population: All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexlansoprazole MR 60 mg QD | Mean Change From Baseline to Month 12 for PAGI-QOL Total Score | 0.56 score on a scale | Standard Deviation 0.725 |
| Dexlansoprazole MR 90 mg QD | Mean Change From Baseline to Month 12 for PAGI-QOL Total Score | 0.61 score on a scale | Standard Deviation 0.809 |
p-value: 0.656ANCOVA
Secondary
Mean Change From Baseline to Month 12 for PAGI-SYM Total Score
Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity).
Time frame: Baseline and Month 12
Population: All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexlansoprazole MR 60 mg QD | Mean Change From Baseline to Month 12 for PAGI-SYM Total Score | -1.08 score on a scale | Standard Deviation 0.915 |
| Dexlansoprazole MR 90 mg QD | Mean Change From Baseline to Month 12 for PAGI-SYM Total Score | -0.95 score on a scale | Standard Deviation 0.879 |
p-value: 0.469ANCOVA
Secondary
Mean Change From Baseline to Month 1 for PAGI-QOL Total Score
Mean overall composite Quality of Life (QOL) score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL.
Time frame: Baseline and Month 1
Population: All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the Patient Assessment of Upper Gastrointestinal Disorders (PAGI) analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexlansoprazole MR 60 mg QD | Mean Change From Baseline to Month 1 for PAGI-QOL Total Score | 0.54 score on a scale | Standard Deviation 0.718 |
| Dexlansoprazole MR 90 mg QD | Mean Change From Baseline to Month 1 for PAGI-QOL Total Score | 0.54 score on a scale | Standard Deviation 0.735 |
p-value: 0.204ANCOVA
Secondary
Mean Change From Baseline to Month 1 for PAGI-SYM Total Score
Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity).
Time frame: Baseline and Month 1
Population: All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexlansoprazole MR 60 mg QD | Mean Change From Baseline to Month 1 for PAGI-SYM Total Score | -0.95 score on a scale | Standard Deviation 0.876 |
| Dexlansoprazole MR 90 mg QD | Mean Change From Baseline to Month 1 for PAGI-SYM Total Score | -0.85 score on a scale | Standard Deviation 0.874 |
p-value: 0.176ANCOVA
Secondary
Mean Change From Baseline to Month 3 for PAGI-QOL Total Score
Mean overall composite QOL score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL.
Time frame: Baseline and Month 3
Population: All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexlansoprazole MR 60 mg QD | Mean Change From Baseline to Month 3 for PAGI-QOL Total Score | 0.61 score on a scale | Standard Deviation 0.827 |
| Dexlansoprazole MR 90 mg QD | Mean Change From Baseline to Month 3 for PAGI-QOL Total Score | 0.56 score on a scale | Standard Deviation 0.754 |
p-value: 0.109ANCOVA
Secondary
Mean Change From Baseline to Month 3 for PAGI-SYM Total Score
Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity).
Time frame: Baseline and Month 3
Population: All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexlansoprazole MR 60 mg QD | Mean Change From Baseline to Month 3 for PAGI-SYM Total Score | -1.09 score on a scale | Standard Deviation 0.913 |
| Dexlansoprazole MR 90 mg QD | Mean Change From Baseline to Month 3 for PAGI-SYM Total Score | -0.91 score on a scale | Standard Deviation 0.896 |
p-value: 0.03ANCOVA
Secondary
Mean Change From Baseline to Month 6 for PAGI-QOL Total Score
Mean overall composite QOL score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL.
Time frame: Baseline and Month 6
Population: All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexlansoprazole MR 60 mg QD | Mean Change From Baseline to Month 6 for PAGI-QOL Total Score | 0.58 score on a scale | Standard Deviation 0.792 |
| Dexlansoprazole MR 90 mg QD | Mean Change From Baseline to Month 6 for PAGI-QOL Total Score | 0.56 score on a scale | Standard Deviation 0.758 |
p-value: 0.286ANCOVA
Secondary
Mean Change From Baseline to Month 6 for PAGI-SYM Total Score
Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity).
Time frame: Baseline and Month 6
Population: All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexlansoprazole MR 60 mg QD | Mean Change From Baseline to Month 6 for PAGI-SYM Total Score | -1.05 score on a scale | Standard Deviation 0.885 |
| Dexlansoprazole MR 90 mg QD | Mean Change From Baseline to Month 6 for PAGI-SYM Total Score | -0.93 score on a scale | Standard Deviation 0.856 |
p-value: 0.243ANCOVA
Secondary
Mean Change From Baseline to Month 9 for PAGI-QOL Total Score
Mean overall composite QOL score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL.
Time frame: Baseline and Month 9
Population: All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexlansoprazole MR 60 mg QD | Mean Change From Baseline to Month 9 for PAGI-QOL Total Score | 0.64 score on a scale | Standard Deviation 0.757 |
| Dexlansoprazole MR 90 mg QD | Mean Change From Baseline to Month 9 for PAGI-QOL Total Score | 0.60 score on a scale | Standard Deviation 0.811 |
p-value: 0.102ANCOVA
Secondary
Mean Change From Baseline to Month 9 for PAGI-SYM Total Score
Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity).
Time frame: Baseline and Month 9
Population: All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexlansoprazole MR 60 mg QD | Mean Change From Baseline to Month 9 for PAGI-SYM Total Score | -1.17 score on a scale | Standard Deviation 0.902 |
| Dexlansoprazole MR 90 mg QD | Mean Change From Baseline to Month 9 for PAGI-SYM Total Score | -0.89 score on a scale | Standard Deviation 0.903 |
p-value: 0.005ANCOVA