Trial Outcomes & Findings for Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Gastroesophageal Reflux Disease (NCT NCT00321984)
NCT ID: NCT00321984
Last Updated: 2011-04-28
Results Overview
The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.
COMPLETED
PHASE3
947 participants
4 weeks
2011-04-28
Participant Flow
Subjects enrolled at 154 sites in the United States (US); date of first dose: 08 June 2006; date of last procedure: 11 December 2006.
Subjects with endoscopically documented normal esophageal mucosa were enrolled in Dexlansoprazole Modified Release (MR) or Placebo once daily (QD) treatment group; subjects were instructed that lifestyle or behavioral modifications designed to treat their symptoms of gastroesophageal reflux disease (GERD) should not be altered throughout the study.
Participant milestones
| Measure |
Placebo QD
Placebo capsules, orally, once daily for up to 4 weeks.
|
Dexlansoprazole MR 30 mg QD
Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks.
|
Dexlansoprazole MR 60 mg QD
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
317
|
315
|
315
|
|
Overall Study
COMPLETED
|
290
|
294
|
289
|
|
Overall Study
NOT COMPLETED
|
27
|
21
|
26
|
Reasons for withdrawal
| Measure |
Placebo QD
Placebo capsules, orally, once daily for up to 4 weeks.
|
Dexlansoprazole MR 30 mg QD
Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks.
|
Dexlansoprazole MR 60 mg QD
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
9
|
6
|
8
|
|
Overall Study
Protocol Violation
|
0
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
4
|
2
|
|
Overall Study
Withdrawal by Subject
|
8
|
6
|
5
|
|
Overall Study
Unmet Inclusion/Exclusion Criteria
|
3
|
1
|
5
|
|
Overall Study
Lack of Efficacy
|
3
|
1
|
3
|
|
Overall Study
Noncompliant
|
0
|
0
|
2
|
|
Overall Study
Pregnancy
|
0
|
1
|
0
|
|
Overall Study
Per Subject Request
|
1
|
0
|
0
|
|
Overall Study
Per Investigator Request
|
1
|
0
|
0
|
|
Overall Study
Per Sponsor Due to High Baseline Gastrin
|
0
|
1
|
0
|
Baseline Characteristics
Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Gastroesophageal Reflux Disease
Baseline characteristics by cohort
| Measure |
Placebo QD
n=317 Participants
Placebo capsules, orally, once daily for up to 4 weeks.
|
Dexlansoprazole MR 30 mg QD
n=315 Participants
Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks.
|
Dexlansoprazole MR 60 mg QD
n=315 Participants
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
|
Total
n=947 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
47.6 years
STANDARD_DEVIATION 14.40 • n=5 Participants
|
47.6 years
STANDARD_DEVIATION 13.55 • n=7 Participants
|
47.5 years
STANDARD_DEVIATION 13.77 • n=5 Participants
|
47.5 years
STANDARD_DEVIATION 13.90 • n=4 Participants
|
|
Age, Customized
<45 years
|
130 participants
n=5 Participants
|
131 participants
n=7 Participants
|
139 participants
n=5 Participants
|
400 participants
n=4 Participants
|
|
Age, Customized
45 to <65 years
|
148 participants
n=5 Participants
|
149 participants
n=7 Participants
|
136 participants
n=5 Participants
|
433 participants
n=4 Participants
|
|
Age, Customized
≥65 years
|
39 participants
n=5 Participants
|
35 participants
n=7 Participants
|
40 participants
n=5 Participants
|
114 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
233 Participants
n=5 Participants
|
231 Participants
n=7 Participants
|
209 Participants
n=5 Participants
|
673 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
84 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
274 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
45 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
130 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
255 Participants
n=5 Participants
|
267 Participants
n=7 Participants
|
251 Participants
n=5 Participants
|
773 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
62 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
182 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
255 Participants
n=5 Participants
|
248 Participants
n=7 Participants
|
262 Participants
n=5 Participants
|
765 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: Analysis was conducted on an intent-to-treat (ITT) population that included all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment. All ITT populations excluded subjects with confirmed Barrett's esophagus and/or definite dysplastic changes.
The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.
Outcome measures
| Measure |
Placebo QD
n=310 Participants
Placebo capsules, orally, once daily for up to 4 weeks.
|
Dexlansoprazole MR 30 mg QD
n=312 Participants
Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks.
|
Dexlansoprazole MR 60 mg QD
n=307 Participants
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
|
|---|---|---|---|
|
Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median
|
18.5 percentage of days
Interval 0.0 to 42.9
|
54.9 percentage of days
Interval 19.7 to 80.9
|
50.0 percentage of days
Interval 14.8 to 80.6
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: Analysis was conducted on an intent-to-treat (ITT) population that included all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment. All ITT populations excluded subjects with confirmed Barrett's esophagus and/or definite dysplastic changes.
The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.
Outcome measures
| Measure |
Placebo QD
n=310 Participants
Placebo capsules, orally, once daily for up to 4 weeks.
|
Dexlansoprazole MR 30 mg QD
n=312 Participants
Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks.
|
Dexlansoprazole MR 60 mg QD
n=307 Participants
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
|
|---|---|---|---|
|
Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean
|
25.0 percentage of days
Standard Deviation 25.6
|
50.3 percentage of days
Standard Deviation 33.9
|
49.1 percentage of days
Standard Deviation 34.7
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: Analysis was conducted on an ITT population (all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment), but excluded subjects without any morning diary entries on Day 1 or later.
The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.
Outcome measures
| Measure |
Placebo QD
n=308 Participants
Placebo capsules, orally, once daily for up to 4 weeks.
|
Dexlansoprazole MR 30 mg QD
n=311 Participants
Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks.
|
Dexlansoprazole MR 60 mg QD
n=307 Participants
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
|
|---|---|---|---|
|
Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median
|
51.7 percentage of days
Interval 16.3 to 74.3
|
80.8 percentage of days
Interval 45.8 to 95.8
|
76.9 percentage of days
Interval 43.3 to 94.4
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: Analysis was conducted on an ITT population (all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment), but excluded subjects without any morning diary entries on Day 1 or later.
The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.
Outcome measures
| Measure |
Placebo QD
n=308 Participants
Placebo capsules, orally, once daily for up to 4 weeks.
|
Dexlansoprazole MR 30 mg QD
n=311 Participants
Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks.
|
Dexlansoprazole MR 60 mg QD
n=307 Participants
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
|
|---|---|---|---|
|
Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean
|
47.1 percentage of days
Standard Deviation 32.6
|
67.6 percentage of days
Standard Deviation 34.1
|
65.0 percentage of days
Standard Deviation 34.3
|
Adverse Events
Placebo QD
Dexlansoprazole MR 30 mg QD
Dexlansoprazole MR 60 mg QD
Serious adverse events
| Measure |
Placebo QD
Placebo capsules, orally, once daily for up to 4 weeks.
|
Dexlansoprazole MR 30 mg QD
Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks.
|
Dexlansoprazole MR 60 mg QD
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
|
|---|---|---|---|
|
Cardiac disorders
Coronary Artery Disorders Not Elsewhere Classified (NEC)
|
0.32%
1/317
|
0.00%
0/315
|
0.00%
0/315
|
|
Cardiac disorders
Ischaemic Coronary Artery Disorders
|
0.00%
0/317
|
0.63%
2/315
|
0.00%
0/315
|
|
Cardiac disorders
Heart Failures NEC
|
0.00%
0/317
|
0.32%
1/315
|
0.00%
0/315
|
|
Infections and infestations
Sepsis, Bacteraemia, Viraemia and Fungaemia NEC
|
0.00%
0/317
|
0.32%
1/315
|
0.00%
0/315
|
|
Gastrointestinal disorders
Gastrointestinal & Abdominal Pains (Excluding Oral and Throat)
|
0.00%
0/317
|
0.00%
0/315
|
0.32%
1/315
|
|
Gastrointestinal disorders
Non-site Specific Gastrointestinal Haemorrhages
|
0.00%
0/317
|
0.00%
0/315
|
0.32%
1/315
|
|
Nervous system disorders
Central Nervous System Haemorrhage & Cerebrovascular Accidents
|
0.00%
0/317
|
0.32%
1/315
|
0.00%
0/315
|
Other adverse events
| Measure |
Placebo QD
Placebo capsules, orally, once daily for up to 4 weeks.
|
Dexlansoprazole MR 30 mg QD
Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks.
|
Dexlansoprazole MR 60 mg QD
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea (Excluding Infective)
|
3.5%
11/317
|
5.7%
18/315
|
4.8%
15/315
|
|
Nervous system disorders
Headaches NEC
|
6.0%
19/317
|
4.1%
13/315
|
2.9%
9/315
|
|
Gastrointestinal disorders
Nausea and Vomiting Symptoms
|
2.8%
9/317
|
5.1%
16/315
|
5.7%
18/315
|
Additional Information
Sr. VP Clinical Sciences
Takeda Global Research & Development Center, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee No publication related to study results will be published prior to publication of a multi-center report submitted for publication within 18 months after conclusion or termination of a study. Results publications will be submitted to sponsor for review 60 days in advance of publication. Sponsor can require removal of confidential information unrelated to study results. Sponsor can embargo a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER