Trial · NCT00251745
Efficacy and Safety of Dexlansoprazole Modified Release Formulation to Treat Heartburn
NCT00251745, Phase 3, Completed, Takeda; results first posted 2009-03-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Dexlansoprazole Modified Release Formulation to Treat Heartburn. Trials, record NCT00251745. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00251745
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Dexlansoprazole Modified Release Formulation to Treat Heartburn
- NCT number
- NCT00251745
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 908 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Gastroesophageal Reflux Disease
- Interventions
- Dexlansoprazole MR, Dexlansoprazole MR, Placebo
- First posted
- 2005-11-10
- Last updated
- 2011-04-28
- Results first posted
- 2009-03-23
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median | 4 weeks | 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. |
| Primary | Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean | 4 weeks | 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. |
| Secondary | Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median | 4 weeks | 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. |
| Secondary | Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean | 4 weeks | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median | 4 weeks | 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. | percentage of days | MEDIAN |
| PRIMARY | Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean | 4 weeks | 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. | percentage of days | MEAN |
| SECONDARY | Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median | 4 weeks | 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. | percentage of days | MEDIAN |
| SECONDARY | Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean | 4 weeks | 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. | percentage of days | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median | Placebo QD | 17.0 | Inter-Quartile Range 0.0 to 42.9 | percentage of days | |
| Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median | Dexlansoprazole MR 60 mg QD | 45.7 | Inter-Quartile Range 11.1 to 75.0 | percentage of days | |
| Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median | Dexlansoprazole MR 90 mg QD | 52.7 | Inter-Quartile Range 15.8 to 79.2 | percentage of days | |
| Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean | Placebo QD | 24.9 | Standard Deviation 25.7 | percentage of days | |
| Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean | Dexlansoprazole MR 60 mg QD | 44.8 | Standard Deviation 33.8 | percentage of days | |
| Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean | Dexlansoprazole MR 90 mg QD | 49.1 | Standard Deviation 34.2 | percentage of days | |
| Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median | Placebo QD | 51.0 | Inter-Quartile Range 18.5 to 81.3 | percentage of days | |
| Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median | Dexlansoprazole MR 60 mg QD | 72.3 | Inter-Quartile Range 34.6 to 92.9 | percentage of days | |
| Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median | Dexlansoprazole MR 90 mg QD | 76.6 | Inter-Quartile Range 37.0 to 92.6 | percentage of days | |
| Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean | Placebo QD | 49.6 | Standard Deviation 34.1 | percentage of days |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo QD | 292 | |
| Overall Study | STARTED | Dexlansoprazole MR 60 mg QD | 312 | |
| Overall Study | STARTED | Dexlansoprazole MR 90 mg QD | 304 | |
| Overall Study | COMPLETED | Placebo QD | 264 | |
| Overall Study | COMPLETED | Dexlansoprazole MR 60 mg QD | 285 | |
| Overall Study | COMPLETED | Dexlansoprazole MR 90 mg QD | 277 | |
| Overall Study | NOT COMPLETED | Placebo QD | 28 | |
| Overall Study | NOT COMPLETED | Dexlansoprazole MR 60 mg QD | 27 | |
| Overall Study | NOT COMPLETED | Dexlansoprazole MR 90 mg QD | 27 |
Source ClinicalTrials.gov
Adverse events24
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea (Excl Infective) | Gastrointestinal disorders | Placebo QD | 13 | 292 | |
| other | Diarrhoea (Excl Infective) | Gastrointestinal disorders | Dexlansoprazole MR 60 mg QD | 15 | 312 | |
| other | Diarrhoea (Excl Infective) | Gastrointestinal disorders | Dexlansoprazole MR 90 mg QD | 8 | 304 | |
| other | Gastrointestinal and Abdominal Pains (Excl Oral and Throat) | Gastrointestinal disorders | Placebo QD | 12 | 292 | |
| other | Gastrointestinal and Abdominal Pains (Excl Oral and Throat) | Gastrointestinal disorders | Dexlansoprazole MR 60 mg QD | 23 | 312 | |
| other | Gastrointestinal and Abdominal Pains (Excl Oral and Throat) | Gastrointestinal disorders | Dexlansoprazole MR 90 mg QD | 15 | 304 | |
| other | Nausea and Vomiting Symptoms | Gastrointestinal disorders | Placebo QD | 10 | 292 | |
| other | Nausea and Vomiting Symptoms | Gastrointestinal disorders | Dexlansoprazole MR 60 mg QD | 15 | 312 | |
| other | Nausea and Vomiting Symptoms | Gastrointestinal disorders | Dexlansoprazole MR 90 mg QD | 9 | 304 | |
| other | Upper Respiratory Tract Infections | Infections and infestations | Placebo QD | 4 | 292 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo QD | ||
| Total, all-cause mortality | Dexlansoprazole MR 60 mg QD | ||
| Total, all-cause mortality | Dexlansoprazole MR 90 mg QD | ||
| Total, other adverse events | Placebo QD | 37 | |
| Total, other adverse events | Dexlansoprazole MR 60 mg QD | 55 | |
| Total, other adverse events | Dexlansoprazole MR 90 mg QD | 54 | |
| Total, serious adverse events | Placebo QD | 0 | |
| Total, serious adverse events | Dexlansoprazole MR 60 mg QD | 2 | |
| Total, serious adverse events | Dexlansoprazole MR 90 mg QD | 1 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 19735233 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00251745
GET https://conductscience.org/api/trials/v1/NCT00251745/events?page=2