Trial · NCT00762359
A Safety and Efficacy Study of Lansoprazole in Preventing Aspirin-Induced Gastric and Duodenal Ulcers
NCT00762359, Phase 3, Terminated, Takeda; results first posted 2011-05-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Safety and Efficacy Study of Lansoprazole in Preventing Aspirin-Induced Gastric and Duodenal Ulcers. Trials, record NCT00762359. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00762359
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Safety and Efficacy Study of Lansoprazole in Preventing Aspirin-Induced Gastric and Duodenal Ulcers
- NCT number
- NCT00762359
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 461 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Stomach Ulcer, Duodenal Ulcer
- Interventions
- Lansoprazole, Gefarnate
- First posted
- 2008-09-30
- Last updated
- 2012-02-03
- Results first posted
- 2011-05-10
- Limitations and caveats
- On September 2008, the Efficacy and Safety Evaluation Committee recommended that this study be discontinued based on the interim analysis.
Source ClinicalTrials.gov
Registered outcomes48
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Gastric Ulcer and/or Duodenal Ulcer | 18 Months | The number of participants that developed gastric ulcer and/or duodenal ulcer at month 18 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater. |
| Secondary | Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3) | Baseline and Month 3. | The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and \<1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves \>6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect \< 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury. |
| Secondary | Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6) | Baseline and Month 6. | The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and \<1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves \>6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect \< 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury. |
| Secondary | Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 9) | Baseline and Month 9. | The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and \<1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves \>6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect \< 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury. |
| Secondary | Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12) | Baseline and Month 12. | The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and \<1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves \>6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect \< 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury. |
| Secondary | Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18) | Baseline and Month 18. | The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and \<1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves \>6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect \< 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury. |
| Secondary | Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3) | Baseline and Month 3. | The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and \< 1 lesion; 2= 2 to 5 lesions ; 3= \> 6 lesions). Erosions are defined as mucosal defect \< 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury. |
| Secondary | Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6) | Baseline and Month 6. | The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and \< 1 lesion; 2= 2 to 5 lesions ; 3= \> 6 lesions). Erosions are defined as mucosal defect \< 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury. |
| Secondary | Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 9) | Baseline and Month 9. | The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and \< 1 lesion; 2= 2 to 5 lesions ; 3= \> 6 lesions). Erosions are defined as mucosal defect \< 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury. |
| Secondary | Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12) | Baseline and Month 12. | The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and \< 1 lesion; 2= 2 to 5 lesions ; 3= \> 6 lesions). Erosions are defined as mucosal defect \< 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury. |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 registered outcomesOutcomes48
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Gastric Ulcer and/or Duodenal Ulcer | 18 Months | Participants not taking investigational drug were not included. | participants | NUMBER |
| SECONDARY | Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3) | Baseline and Month 3. | Values are from the Full Analysis Set. | scores on a scale | MEAN |
| SECONDARY | Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6) | Baseline and Month 6. | Values are from the Full Analysis Set. | scores on a scale | MEDIAN |
| SECONDARY | Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 9) | Baseline and Month 9. | Values are from the Full Analysis Set. | scores on a scale | MEAN |
| SECONDARY | Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12) | Baseline and Month 12. | Values are from the Full Analysis Set. | scores on a scale | MEAN |
| SECONDARY | Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18) | Baseline and Month 18. | No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set. | scores on a scale | MEAN |
| SECONDARY | Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3) | Baseline and Month 3. | Values are from the Full Analysis Set. | scores on a scale | MEAN |
| SECONDARY | Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6) | Baseline and Month 6. | Values are from the Full Analysis Set. | scores on a scale | MEAN |
| SECONDARY | Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 9) | Baseline and Month 9. | Values are from the Full Analysis Set. | scores on a scale | MEAN |
| SECONDARY | Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12) | Baseline and Month 12. | Values are from the Full Analysis Set. | scores on a scale | MEAN |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 outcomesResults by group100
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Gastric Ulcer and/or Duodenal Ulcer | Lansoprazole 15 mg QD | 6 | participants | ||
| Number of Participants With Gastric Ulcer and/or Duodenal Ulcer | Gefarnate 50 mg BID | 53 | participants | ||
| Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3) | Lansoprazole 15 mg QD | -0.150 | Standard Deviation 0.904 | scores on a scale | |
| Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3) | Gefarnate 50 mg BID | 0.460 | Standard Deviation 1.241 | scores on a scale | |
| Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6) | Lansoprazole 15 mg QD | -0.153 | Standard Deviation 1.172 | scores on a scale | |
| Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6) | Gefarnate 50 mg BID | 0.530 | Standard Deviation 1.444 | scores on a scale | |
| Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 9) | Lansoprazole 15 mg QD | -0.149 | Standard Deviation 1.157 | scores on a scale | |
| Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 9) | Gefarnate 50 mg BID | 0.419 | Standard Deviation 1.375 | scores on a scale | |
| Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12) | Lansoprazole 15 mg QD | -0.224 | Standard Deviation 1.112 | scores on a scale | |
| Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12) | Gefarnate 50 mg BID | 0.205 | Standard Deviation 1.047 | scores on a scale |
1 to 10 of 100Source ClinicalTrials.gov
See all 100 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lansoprazole 15 mg QD | 226 | |
| Overall Study | STARTED | Gefarnate 50 mg BID | 235 | |
| Overall Study | COMPLETED | Lansoprazole 15 mg QD | 167 | |
| Overall Study | COMPLETED | Gefarnate 50 mg BID | 178 | |
| Overall Study | NOT COMPLETED | Lansoprazole 15 mg QD | 59 | |
| Overall Study | NOT COMPLETED | Gefarnate 50 mg BID | 57 |
Source ClinicalTrials.gov
Adverse events96
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 | Constipation | Gastrointestinal disorders | Lansoprazole 15 mg QD | 14 | 226 | |
| other | Constipation | Gastrointestinal disorders | Gefarnate 50 mg BID | 8 | 234 | |
| other | Diarrhoea | Gastrointestinal disorders | Lansoprazole 15 mg QD | 19 | 226 | |
| other | Diarrhoea | Gastrointestinal disorders | Gefarnate 50 mg BID | 2 | 234 | |
| other | Reflux oesophagitis | Gastrointestinal disorders | Lansoprazole 15 mg QD | 3 | 226 | |
| other | Reflux oesophagitis | Gastrointestinal disorders | Gefarnate 50 mg BID | 16 | 234 | |
| other | Nasopharyngitis | Infections and infestations | Lansoprazole 15 mg QD | 51 | 226 | |
| other | Nasopharyngitis | Infections and infestations | Gefarnate 50 mg BID | 45 | 234 | |
| other | Fall | Injury, poisoning and procedural complications | Lansoprazole 15 mg QD | 13 | 226 | |
| other | Fall | Injury, poisoning and procedural complications | Gefarnate 50 mg BID | 9 | 234 |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lansoprazole 15 mg QD | ||
| Total, all-cause mortality | Gefarnate 50 mg BID | ||
| Total, other adverse events | Lansoprazole 15 mg QD | 82 | 226 |
| Total, other adverse events | Gefarnate 50 mg BID | 68 | 234 |
| Total, serious adverse events | Lansoprazole 15 mg QD | 27 | 226 |
| Total, serious adverse events | Gefarnate 50 mg BID | 26 | 234 |
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Lansoprazole 15 mg QD vs Gefarnate 50 mg BID: Number of Participants With Gastric or Duodenal Ulcer or Gastric or Duodenal Hemorrhagic Lesion (Upper Gastrointestinal Hemorrhage) | Trial comparisons |
| Lansoprazole 15 mg QD vs Gefarnate 50 mg BID: Number of Participants With Gastric Ulcer and/or Duodenal Ulcer | Trial comparisons |
| Lansoprazole 15 mg QD vs Gefarnate 50 mg BID: serious adverse events | 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/NCT00762359
GET https://conductscience.org/api/trials/v1/NCT00762359/registered?page=2