Trial Outcomes & Findings for Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Heartburn (NCT NCT00251758)
NCT ID: NCT00251758
Last Updated: 2010-05-18
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
908 participants
4 weeks
2010-05-18
Participant Flow
Subjects enrolled at 157 sites in the United States (75 in Study T-GD04-082 \[NCT00251745\] and 82 in Study T-GD04-083 \[this posting, NCT00251758\]; date of first dose: 07 December 2005; date of last procedure: 23 May 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 60 mg QD
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
|
Dexlansoprazole MR 90 mg QD
Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
292
|
312
|
304
|
|
Overall Study
COMPLETED
|
264
|
285
|
277
|
|
Overall Study
NOT COMPLETED
|
28
|
27
|
27
|
Reasons for withdrawal
| Measure |
Placebo QD
Placebo 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.
|
Dexlansoprazole MR 90 mg QD
Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
7
|
9
|
11
|
|
Overall Study
Lost to Follow-up
|
4
|
2
|
5
|
|
Overall Study
Withdrawal by Subject
|
13
|
7
|
3
|
|
Overall Study
Unmet Inclusion/Exclusion Criteria
|
0
|
6
|
5
|
|
Overall Study
Lack of Efficacy
|
3
|
0
|
0
|
|
Overall Study
Noncompliant
|
0
|
2
|
2
|
|
Overall Study
Pregnancy
|
0
|
1
|
0
|
|
Overall Study
Per Subject Request
|
0
|
0
|
1
|
|
Overall Study
Per Investigator Request
|
1
|
0
|
0
|
Baseline Characteristics
Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Heartburn
Baseline characteristics by cohort
| Measure |
Placebo QD
n=292 Participants
Placebo capsules, orally, once daily for up to 4 weeks.
|
Dexlansoprazole MR 60 mg QD
n=312 Participants
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
|
Dexlansoprazole MR 90 mg QD
n=304 Participants
Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
|
Total
n=908 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
49.0 years
STANDARD_DEVIATION 13.60 • n=5 Participants
|
48.0 years
STANDARD_DEVIATION 13.55 • n=7 Participants
|
46.7 years
STANDARD_DEVIATION 13.64 • n=5 Participants
|
47.9 years
STANDARD_DEVIATION 13.61 • n=4 Participants
|
|
Age, Customized
<45 years
|
107 participants
n=5 Participants
|
125 participants
n=7 Participants
|
135 participants
n=5 Participants
|
367 participants
n=4 Participants
|
|
Age, Customized
45 - <65 years
|
146 participants
n=5 Participants
|
155 participants
n=7 Participants
|
139 participants
n=5 Participants
|
440 participants
n=4 Participants
|
|
Age, Customized
≥65 years
|
39 participants
n=5 Participants
|
32 participants
n=7 Participants
|
30 participants
n=5 Participants
|
101 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
216 Participants
n=5 Participants
|
214 Participants
n=7 Participants
|
213 Participants
n=5 Participants
|
643 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
76 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
265 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
34 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
121 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
240 Participants
n=5 Participants
|
246 Participants
n=7 Participants
|
245 Participants
n=5 Participants
|
731 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
60 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
179 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
232 Participants
n=5 Participants
|
254 Participants
n=7 Participants
|
243 Participants
n=5 Participants
|
729 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=290 Participants
Placebo capsules, orally, once daily for up to 4 weeks.
|
Dexlansoprazole MR 60 mg QD
n=306 Participants
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
|
Dexlansoprazole MR 90 mg QD
n=298 Participants
Dexlansoprazole MR 90 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
|
17.0 percentage of days
Interval 0.0 to 42.9
|
45.7 percentage of days
Interval 11.1 to 75.0
|
52.7 percentage of days
Interval 15.8 to 79.2
|
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=290 Participants
Placebo capsules, orally, once daily for up to 4 weeks.
|
Dexlansoprazole MR 60 mg QD
n=306 Participants
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
|
Dexlansoprazole MR 90 mg QD
n=298 Participants
Dexlansoprazole MR 90 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
|
24.9 percentage of days
Standard Deviation 25.7
|
44.8 percentage of days
Standard Deviation 33.8
|
49.1 percentage of days
Standard Deviation 34.2
|
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=290 Participants
Placebo capsules, orally, once daily for up to 4 weeks.
|
Dexlansoprazole MR 60 mg QD
n=306 Participants
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
|
Dexlansoprazole MR 90 mg QD
n=298 Participants
Dexlansoprazole MR 90 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
|
51.0 percentage of days
Interval 18.5 to 81.3
|
72.3 percentage of days
Interval 34.6 to 92.9
|
76.6 percentage of days
Interval 37.0 to 92.6
|
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=290 Participants
Placebo capsules, orally, once daily for up to 4 weeks.
|
Dexlansoprazole MR 60 mg QD
n=306 Participants
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
|
Dexlansoprazole MR 90 mg QD
n=298 Participants
Dexlansoprazole MR 90 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
|
49.6 percentage of days
Standard Deviation 34.1
|
62.0 percentage of days
Standard Deviation 34.5
|
64.4 percentage of days
Standard Deviation 34.6
|
Adverse Events
Placebo QD
Dexlansoprazole MR 60 mg QD
Dexlansoprazole MR 90 mg QD
Serious adverse events
| Measure |
Placebo QD
Placebo 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.
|
Dexlansoprazole MR 90 mg QD
Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
|
|---|---|---|---|
|
Hepatobiliary disorders
Cholecystitis and Cholelithiasis
|
0.00%
0/292
|
0.00%
0/312
|
0.33%
1/304
|
|
Injury, poisoning and procedural complications
Non-site Specific Injuries Not Elsewhere Classified (NEC)
|
0.00%
0/292
|
0.32%
1/312
|
0.00%
0/304
|
|
Injury, poisoning and procedural complications
Poisoning and Toxicity
|
0.00%
0/292
|
0.32%
1/312
|
0.00%
0/304
|
Other adverse events
| Measure |
Placebo QD
Placebo 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.
|
Dexlansoprazole MR 90 mg QD
Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea (Excl Infective)
|
4.5%
13/292
|
4.8%
15/312
|
2.6%
8/304
|
|
Gastrointestinal disorders
Gastrointestinal and Abdominal Pains (Excl Oral and Throat)
|
4.1%
12/292
|
7.4%
23/312
|
4.9%
15/304
|
|
Gastrointestinal disorders
Nausea and Vomiting Symptoms
|
3.4%
10/292
|
4.8%
15/312
|
3.0%
9/304
|
|
Infections and infestations
Upper Respiratory Tract Infections
|
1.4%
4/292
|
3.5%
11/312
|
7.9%
24/304
|
|
Nervous system disorders
Headaches NEC
|
5.1%
15/292
|
4.2%
13/312
|
3.6%
11/304
|
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