Trial · NCT01669811
Compare D961H 20 mg Bid and 20 mg qd in Patients With Refractory Reflux Esophagitis (Inflammation of Lower Esophagus)
NCT01669811, Phase 3, Completed, AstraZeneca; results first posted 2015-08-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Compare D961H 20 mg Bid and 20 mg qd in Patients With Refractory Reflux Esophagitis (Inflammation of Lower Esophagus). Trials, record NCT01669811. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01669811
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Compare D961H 20 mg Bid and 20 mg qd in Patients With Refractory Reflux Esophagitis (Inflammation of Lower Esophagus)
- NCT number
- NCT01669811
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,398 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Refractory Reflux Esophagitis
- Interventions
- Esomeprazole (D961H) twice daily, Esomeprazole (D961H) once daily
- First posted
- 2012-08-21
- Last updated
- 2015-08-27
- Results first posted
- 2015-08-14
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Healing of RE Who Were Graded "O" at Week 8 Out of Participants Who Were Graded "A" to "D" at Baseline According to Los Angeles Classification | 8 Weeks | Percentage of participants with healing of reflux esophagitis (RE) who were graded "O" (No RE) at Week 8 out of participants who were graded "A" (least severe) to "D" (most severe) at baseline according to Los Angeles classification |
| Secondary | Percentage of Participants With Healing of RE Who Were Graded "O" at Week 4 Out of Participants Who Were Graded "A" to "D" at Baseline According to Los Angeles Classification | 4 Weeks | Percentage of participants with healing of reflux esophagitis (RE) who were graded "O" (No RE) at Week 4 out of participants who were graded "A" (least severe) to "D" (most severe) at baseline according to Los Angeles classification |
| Secondary | Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Heartburn at Week 4 | 4 Weeks | Cumulative percentage of participants who had sustained resolution (defined as at least 7-day consecutive symptom free) of gastroesophageal reflux disease (GERD) symptom -heartburn at Week 4 (on Day 29) based on the Kaplan-Meier method. |
| Secondary | Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Acid Regurgitation at Week 4 | 4 Weeks | Cumulative percentage of participants who had sustained resolution (defined as at least 7-day consecutive symptom free) of gastroesophageal reflux disease (GERD) symptom -acid regurgitation at Week 4 (on Day 29) based on the Kaplan-Meier method. |
| Secondary | Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Abdominal Pain at Week 4 | 4 Weeks | Cumulative percentage of participants who had sustained resolution (defined as at least 7-day consecutive symptom free) of gastroesophageal reflux disease (GERD) symptom -abdominal pain at Week 4 (on Day 29) based on the Kaplan-Meier method. |
| Secondary | Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Difficulty of Swallowing at Week 4 | 4 Weeks | Cumulative percentage of participants who had sustained resolution (defined as at least 7-day consecutive symptom free) of gastroesophageal reflux disease (GERD) symptom -difficulty of swallowing at Week 4 (on Day 29) based on the Kaplan-Meier method. |
| Secondary | Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Sleep Disturbance at Week 4 | 4 Weeks | Cumulative percentage of participants who had sustained resolution (defined as at least 7-day consecutive symptom free) of gastroesophageal reflux disease (GERD) symptom -sleep disturbance at Week 4 (on Day 29) based on the Kaplan-Meier method. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Healing of RE Who Were Graded O at Week 8 Out of Participants Who Were Graded A to D at Baseline According to Los Angeles Classification | 8 Weeks | Included all of the randomised participants who were definitely diagnosed to have refractory RE before the randomisation and who had at least one dose of investigational product | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Healing of RE Who Were Graded O at Week 4 Out of Participants Who Were Graded A to D at Baseline According to Los Angeles Classification | 4 Weeks | Included all of the randomised participants who were definitely diagnosed to have refractory RE before the randomisation and who had at least one dose of investigational product | Percentage of participants | NUMBER |
| SECONDARY | Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Heartburn at Week 4 | 4 Weeks | Included all of the randomised participants who were definitely diagnosed to have refractory RE before the randomisation and who took at least one dose of investigational product. However, out of these participants, only participants who had the GERD symptom -heartburn at baseline were included. | Percentage of participants | NUMBER |
| SECONDARY | Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Acid Regurgitation at Week 4 | 4 Weeks | Included all of the randomised participants who were definitely diagnosed to have refractory RE before the randomisation and who took at least one dose of investigational product. However, out of these participants, only participants who had the GERD symptom -acid regurgitation at baseline were included. | Percentage of participants | NUMBER |
| SECONDARY | Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Abdominal Pain at Week 4 | 4 Weeks | Included all of the randomised participants who were definitely diagnosed to have refractory RE before the randomisation and who took at least one dose of investigational product. However, out of these participants, only participants who had the GERD symptom -abdominal pain at baseline were included. | Percentage of participants | NUMBER |
| SECONDARY | Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Difficulty of Swallowing at Week 4 | 4 Weeks | Included all of the randomised participants who were definitely diagnosed to have refractory RE before the randomisation and who took at least one dose of investigational product. However, out of these participants, only participants who had the GERD symptom -difficulty of swallowing at baseline were included. | Percentage of participants | NUMBER |
| SECONDARY | Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Sleep Disturbance at Week 4 | 4 Weeks | Included all of the randomised participants who were definitely diagnosed to have refractory RE before the randomisation and who took at least one dose of investigational product. However, out of these participants, only participants who had the GERD symptom -sleep disturbance at baseline were included. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Healing of RE Who Were Graded O at Week 8 Out of Participants Who Were Graded A to D at Baseline According to Los Angeles Classification | D961H 20mg Bid | 92.4 | 95% Confidence Interval 86.9 to 95.7 | Percentage of participants | |
| Percentage of Participants With Healing of RE Who Were Graded O at Week 8 Out of Participants Who Were Graded A to D at Baseline According to Los Angeles Classification | D961H 20mg QD + Placebo | 68.6 | 95% Confidence Interval 60.5 to 75.7 | Percentage of participants | |
| Percentage of Participants With Healing of RE Who Were Graded O at Week 4 Out of Participants Who Were Graded A to D at Baseline According to Los Angeles Classification | D961H 20mg Bid | 81.4 | 95% Confidence Interval 74.3 to 86.9 | Percentage of participants | |
| Percentage of Participants With Healing of RE Who Were Graded O at Week 4 Out of Participants Who Were Graded A to D at Baseline According to Los Angeles Classification | D961H 20mg QD + Placebo | 48.6 | 95% Confidence Interval 40.4 to 56.8 | Percentage of participants | |
| Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Heartburn at Week 4 | D961H 20mg Bid | 81.1 | 74.3 to 86.9 | Percentage of participants | |
| Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Heartburn at Week 4 | D961H 20mg QD + Placebo | 72.8 | 40.4 to 56.8 | Percentage of participants | |
| Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Acid Regurgitation at Week 4 | D961H 20mg Bid | 73.1 | 74.3 to 86.9 | Percentage of participants | |
| Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Acid Regurgitation at Week 4 | D961H 20mg QD + Placebo | 61.2 | 40.4 to 56.8 | Percentage of participants | |
| Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Abdominal Pain at Week 4 | D961H 20mg Bid | 68.1 | 74.3 to 86.9 | Percentage of participants | |
| Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Abdominal Pain at Week 4 | D961H 20mg QD + Placebo | 59.1 | 40.4 to 56.8 | Percentage of participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | D961H 20 mg BID | 145 | |
| Overall Study | STARTED | D961H 20 mg QD + Placebo | 142 | |
| Overall Study | COMPLETED | D961H 20 mg BID | 142 | |
| Overall Study | COMPLETED | D961H 20 mg QD + Placebo | 131 | |
| Overall Study | NOT COMPLETED | D961H 20 mg BID | 3 | |
| Overall Study | NOT COMPLETED | D961H 20 mg QD + Placebo | 11 |
Source ClinicalTrials.gov
Adverse events10
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 | Nasopharyngitis | Infections and infestations | D961H 20 mg BID | 8 | 145 | 8 |
| other | Nasopharyngitis | Infections and infestations | D961H 20 mg QD + Placebo | 9 | 142 | 9 |
| serious | Gastritis | Gastrointestinal disorders | D961H 20 mg BID | 0 | 145 | 0 |
| serious | Gastritis | Gastrointestinal disorders | D961H 20 mg QD + Placebo | 1 | 142 | 1 |
| serious | Gastrooesophageal reflux disease | Gastrointestinal disorders | D961H 20 mg BID | 0 | 145 | 0 |
| serious | Gastrooesophageal reflux disease | Gastrointestinal disorders | D961H 20 mg QD + Placebo | 1 | 142 | 1 |
| serious | Pancreatic pseudocyst | Gastrointestinal disorders | D961H 20 mg BID | 1 | 145 | 1 |
| serious | Pancreatic pseudocyst | Gastrointestinal disorders | D961H 20 mg QD + Placebo | 0 | 142 | 0 |
| serious | Parotid abscess | Infections and infestations | D961H 20 mg BID | 0 | 145 | 0 |
| serious | Parotid abscess | Infections and infestations | D961H 20 mg QD + Placebo | 1 | 142 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | D961H 20 mg BID | ||
| Total, all-cause mortality | D961H 20 mg QD + Placebo | ||
| Total, other adverse events | D961H 20 mg BID | 8 | 145 |
| Total, other adverse events | D961H 20 mg QD + Placebo | 9 | 142 |
| Total, serious adverse events | D961H 20 mg BID | 1 | 145 |
| Total, serious adverse events | D961H 20 mg QD + Placebo | 3 | 142 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| D961H 20 mg BID vs D961H 20 mg QD + Placebo: serious adverse events |
Source Trial comparisons
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/NCT01669811
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