Trial · NCT00401752
Efficacy and Safety Study of Esomeprazole 20mg qd vs Ranitidine 150mg Bid in Patients With an NSAID-induced Gastric Ulcer
NCT00401752, Phase 3, Completed, AstraZeneca; results first posted 2010-07-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety Study of Esomeprazole 20mg qd vs Ranitidine 150mg Bid in Patients With an NSAID-induced Gastric Ulcer. Trials, record NCT00401752. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00401752
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of Esomeprazole 20mg qd vs Ranitidine 150mg Bid in Patients With an NSAID-induced Gastric Ulcer
- NCT number
- NCT00401752
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 397 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Gastric Ulcer
- Interventions
- Esomeprazole, Ranitidine
- First posted
- 2006-11-22
- Last updated
- 2010-07-08
- Results first posted
- 2010-07-08
- Limitations and caveats
According to the protocol, the sample size was 320 patients which could achieve 80% power of superiority. Since the patient recruitment is very difficult, total 219 patients were randomized in present study, the power decreased to 60%
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Percentage of Subjects Whose Gastric Ulcer(s) (GUs) Was (Were) Healed at Week 4 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily Non-steroidal Anti-inflammatory Drug (NSAID)Therapy. | 4 weeks | Healed was defined as the absence of gastric ulcers. It was calculated as the proportion of subjects whose gastric ulcer(s) healed after 4 weeks treatment. (Ulcers were on S stage, stage 1 = Nonblanchable erythema of intact skin, stage 2 = Partial thickness skin loss involving epidermis, dermis, or both, stage 3 = Full thickness skin loss involving damage to or necrosis of subcutaneous tissue, stage 4 = Full thickness skin loss with extensive destruction, tissue necrosis, or damage to muscle, bone, or supporting structures or absent). |
| Secondary | The Percentage of Subjects Whose Gastric Ulcer(s) Was (Were) Healed at Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy. | 8 weeks | Healed was defined as the absence of gastric ulcers (Ulcers were on S stage or absent). It was calculated as the proportion of subjects whose gastric ulcer(s) healed after 8 weeks treatment. |
| Secondary | The Resolution of Heartburn Symptoms at Week 4 and Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy. | week 4 and week 8 | Resolution rate of investigator-assessed GI symptoms, including heartburn, acid regurgitation, nausea, abdominal fullness and sleep disorder. It was calculated as the percentage of subjects whose heartburn symptoms were resolved at Week 8. |
| Secondary | Percentage of Participants With the Occurance of Any Adverse Event. | 8 weeks | Safety evaluation including vital signs, physical examination, ECG, adverse events and clinical laboratory evaluations during 8 weeks treatment. |
| Secondary | The Percentage of Participants Whose Duodenal Ulcer(s) (DUs) Was (Were) Healed at Week 4 and Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy. | 4 and 8 week | Healed was defined as the absence of ulcers (Ulcers were on S stage or absent). It was calculated as the proportion of subjects whose duodenal ulcer healed after 4 and 8 weeks treatment. |
| Secondary | The Percentage of Participants Whose GU(s) and DU(s) in Combination Were Healed at Week 4 and Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy | 4 & 8 weeks | Healed was defined as the absence of ulcers (Ulcers were on S stage or absent). It was calculated as the proportion of subjects whose gastric and duodenal ulcer healed after 4 and 8 weeks treatment. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Percentage of Subjects Whose Gastric Ulcer(s) (GUs) Was (Were) Healed at Week 4 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily Non-steroidal Anti-inflammatory Drug (NSAID)Therapy. | 4 weeks | Percentage of participants | NUMBER | |
| SECONDARY | The Percentage of Subjects Whose Gastric Ulcer(s) Was (Were) Healed at Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy. | 8 weeks | Percentage of participants | NUMBER | |
| SECONDARY | The Resolution of Heartburn Symptoms at Week 4 and Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy. | week 4 and week 8 | Percentage of participants | NUMBER | |
| SECONDARY | Percentage of Participants With the Occurance of Any Adverse Event. | 8 weeks | Patients included in safety population | Percentage of participants | NUMBER |
| SECONDARY | The Percentage of Participants Whose Duodenal Ulcer(s) (DUs) Was (Were) Healed at Week 4 and Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy. | 4 and 8 week | Percentage of participants | NUMBER | |
| SECONDARY | The Percentage of Participants Whose GU(s) and DU(s) in Combination Were Healed at Week 4 and Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy | 4 & 8 weeks | Percentage of participants | NUMBER |
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 |
|---|---|---|---|---|---|
The Percentage of Subjects Whose Gastric Ulcer(s) (GUs) Was (Were) Healed at Week 4 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily Non-steroidal Anti-inflammatory Drug (NSAID)Therapy. | Esomeprazole | 59.4 | Percentage of participants | ||
The Percentage of Subjects Whose Gastric Ulcer(s) (GUs) Was (Were) Healed at Week 4 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily Non-steroidal Anti-inflammatory Drug (NSAID)Therapy. | Ranitidine | 59.5 | Percentage of participants | ||
| The Percentage of Subjects Whose Gastric Ulcer(s) Was (Were) Healed at Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy. | Esomeprazole | 81.1 | Percentage of participants | ||
| The Percentage of Subjects Whose Gastric Ulcer(s) Was (Were) Healed at Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy. | Ranitidine | 73.9 | Percentage of participants | ||
| The Resolution of Heartburn Symptoms at Week 4 and Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy. | Esomeprazole | 100 | Percentage of participants | ||
| The Resolution of Heartburn Symptoms at Week 4 and Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy. | Ranitidine | 97.7 | Percentage of participants | ||
| Percentage of Participants With the Occurance of Any Adverse Event. | Esomeprazole | 16.8 | Percentage of participants | ||
| Percentage of Participants With the Occurance of Any Adverse Event. | Ranitidine | 22.7 | Percentage of participants | ||
The Percentage of Participants Whose Duodenal Ulcer(s) (DUs) Was (Were) Healed at Week 4 and Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy. | Esomeprazole | 93.3 | Percentage of participants | ||
The Percentage of Participants Whose Duodenal Ulcer(s) (DUs) Was (Were) Healed at Week 4 and Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy. | Ranitidine | 81.8 | Percentage of participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Esomeprazole | 107 | |
| Overall Study | STARTED | Ranitidine | 112 | |
| Overall Study | Number of Patients Received Treatment | Esomeprazole | 107 | |
| Overall Study | Number of Patients Received Treatment | Ranitidine | 111 | |
| Overall Study | Patients Included in ITT Population | Esomeprazole | 106 | |
| Overall Study | Patients Included in ITT Population | Ranitidine | 111 | |
| Overall Study | Patients Included in Safety Population | Esomeprazole | 107 | |
| Overall Study | Patients Included in Safety Population | Ranitidine | 110 | |
| Overall Study | Patients Included in Per-Protocol Popula | Esomeprazole | 100 | |
| Overall Study | Patients Included in Per-Protocol Popula | Ranitidine | 99 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse 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 | Dizziness | Nervous system disorders | Esomeprazole | 0 | 107 | |
| other | Dizziness | Nervous system disorders | Ranitidine | 5 | 110 | |
| other | Gastritis erosive | Gastrointestinal disorders | Esomeprazole | 3 | 107 | |
| other | Gastritis erosive | Gastrointestinal disorders | Ranitidine | 4 | 110 | |
| other | Alanine aminotransferase increased | Hepatobiliary disorders | Esomeprazole | 2 | 107 | |
| other | Alanine aminotransferase increased | Hepatobiliary disorders | Ranitidine | 0 | 110 | |
| other | Aspartate aminotransferase increased | Hepatobiliary disorders | Esomeprazole | 2 | 107 | |
| other | Aspartate aminotransferase increased | Hepatobiliary disorders | Ranitidine | 0 | 110 | |
| other | Gastric ulcer | Gastrointestinal disorders | Esomeprazole | 2 | 107 | |
| other | Gastric ulcer | Gastrointestinal disorders | Ranitidine | 1 | 110 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Esomeprazole | ||
| Total, all-cause mortality | Ranitidine | ||
| Total, other adverse events | Esomeprazole | 13 | |
| Total, other adverse events | Ranitidine | 16 | |
| Total, serious adverse events | Esomeprazole | 2 | 107 |
| Total, serious adverse events | Ranitidine | 2 | 110 |
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 |
|---|
| Esomeprazole vs Ranitidine: 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/NCT00401752
GET https://conductscience.org/api/trials/v1/NCT00401752/events?page=2