Trial · NCT00450658
Efficacy and Safety Study of HZT-501 in Reducing the Risk of Ibuprofen-associated Ulcers
NCT00450658, Phase 3, Completed, Amgen; results first posted 2011-06-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety Study of HZT-501 in Reducing the Risk of Ibuprofen-associated Ulcers. Trials, record NCT00450658. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00450658
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of HZT-501 in Reducing the Risk of Ibuprofen-associated Ulcers
- NCT number
- NCT00450658
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 627 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Peptic Ulcer
- Interventions
- HZT-501, Ibuprofen
- First posted
- 2007-03-22
- Last updated
- 2024-12-16
- Results first posted
- 2011-06-21
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects Who Develop Endoscopically-diagnosed Upper Gastrointestinal Ulcers Confirmed by Endoscopy. | 24 weeks | The primary efficacy endpoint was the number of subjects with upper gastrointestinal (i.e., gastric and/or duodenal) ulcer at any time throughout 24 weeks of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter with unequivocal depth. A subject is considered to have completed the study if all scheduled assessments up through the Week 24 visit have been performed. |
| Secondary | Number of Subjects Who Develop Endoscopically-diagnosed Gastric Ulcers During the 24-week Treatment Period. | 24 weeks | The secondary efficacy endpoint was the number of subjects with gastric ulcer at any time throughout 24 weeks of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter with unequivocal depth. A subject is considered to have completed the study if all scheduled assessments up through the Week 24 visit have been performed. |
| Secondary | Number of Subjects Who Develop Endoscopically-diagnosed Duodenal Ulcers During the 24-week Treatment Period. | 24 weeks | The secondary efficacy endpoint was the number of subjects with duodenal ulcer at any time throughout the 24 weeks of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter with unequivocal depth. A subject is considered to have completed the study if all scheduled assessments up through the Week 24 visit have been performed. |
| Secondary | The Incidence Rate of NSAID-associated Serious Gastrointestinal Complications. | 24 weeks | The secondary efficacy endpoint was the number of subjects developing a NSAID-associated serious GI complication at any time throughout 6 months of treatment. A NSAID-associated serious GI complication was defined as a perforation of ulcers, gastric outlet obstruction due to ulcers, and/or GI bleeding. |
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 | Number of Subjects Who Develop Endoscopically-diagnosed Upper Gastrointestinal Ulcers Confirmed by Endoscopy. | 24 weeks | All randomized subjects who received at least one dose of study drug and who underwent a baseline endoscopic examination and at least the Week 8 endoscopic examination. | participants | NUMBER |
| SECONDARY | Number of Subjects Who Develop Endoscopically-diagnosed Gastric Ulcers During the 24-week Treatment Period. | 24 weeks | The secondary efficacy endpoint was the number of subjects with gastric ulcer at any time throughout 24 weeks of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter with unequivocal depth. A subject is considered to have completed the study if all scheduled assessments up through the Week 24 visit were performed. | participants | NUMBER |
| SECONDARY | Number of Subjects Who Develop Endoscopically-diagnosed Duodenal Ulcers During the 24-week Treatment Period. | 24 weeks | participants | NUMBER | |
| SECONDARY | The Incidence Rate of NSAID-associated Serious Gastrointestinal Complications. | 24 weeks | All randomized subjects who received at least one dose of study drug and who underwent a baseline endoscopic exam. Subjects were assigned according to the treatment to which they received. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects Who Develop Endoscopically-diagnosed Upper Gastrointestinal Ulcers Confirmed by Endoscopy. | HZT-501 | 40 | 3.0 to 15.9 | participants | |
| Number of Subjects Who Develop Endoscopically-diagnosed Upper Gastrointestinal Ulcers Confirmed by Endoscopy. | Ibuprofen | 38 | 3.0 to 15.9 | participants | |
| Number of Subjects Who Develop Endoscopically-diagnosed Gastric Ulcers During the 24-week Treatment Period. | HZT-501 | 37 | 1.9 to 14.4 | participants | |
| Number of Subjects Who Develop Endoscopically-diagnosed Gastric Ulcers During the 24-week Treatment Period. | Ibuprofen | 34 | 1.9 to 14.4 | participants | |
| Number of Subjects Who Develop Endoscopically-diagnosed Duodenal Ulcers During the 24-week Treatment Period. | HZT-501 | 3 | 0.8 to 7.1 | participants | |
| Number of Subjects Who Develop Endoscopically-diagnosed Duodenal Ulcers During the 24-week Treatment Period. | Ibuprofen | 9 | 0.8 to 7.1 | participants | |
| The Incidence Rate of NSAID-associated Serious Gastrointestinal Complications. | HZT-501 | 0 | participants | ||
| The Incidence Rate of NSAID-associated Serious Gastrointestinal Complications. | Ibuprofen | 0 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | HZT-501 | 415 | |
| Overall Study | STARTED | Ibuprofen | 212 | |
| Overall Study | COMPLETED | HZT-501 | 272 | |
| Overall Study | COMPLETED | Ibuprofen | 122 | |
| Overall Study | NOT COMPLETED | HZT-501 | 143 | |
| Overall Study | NOT COMPLETED | Ibuprofen | 90 |
Source ClinicalTrials.gov
Adverse events118
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 | abdominal distension | Gastrointestinal disorders | HZT-501 | 5 | 415 | |
| other | abdominal distension | Gastrointestinal disorders | Ibuprofen | 2 | 212 | |
| other | abdominal pain | Gastrointestinal disorders | HZT-501 | 7 | 415 | |
| other | abdominal pain | Gastrointestinal disorders | Ibuprofen | 4 | 212 | |
| other | abdominal pain upper | Gastrointestinal disorders | HZT-501 | 14 | 415 | |
| other | abdominal pain upper | Gastrointestinal disorders | Ibuprofen | 6 | 212 | |
| other | anemia | Blood and lymphatic system disorders | HZT-501 | 3 | 415 | |
| other | anemia | Blood and lymphatic system disorders | Ibuprofen | 5 | 212 | |
| other | arthralgia | Musculoskeletal and connective tissue disorders | HZT-501 | 2 | 415 | |
| other | arthralgia | Musculoskeletal and connective tissue disorders | Ibuprofen | 3 | 212 |
1 to 10 of 118Source ClinicalTrials.gov
See all 118 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | HZT-501 | ||
| Total, all-cause mortality | Ibuprofen | ||
| Total, other adverse events | HZT-501 | 220 | 415 |
| Total, other adverse events | Ibuprofen | 116 | 212 |
| Total, serious adverse events | HZT-501 | 11 | 415 |
| Total, serious adverse events | Ibuprofen | 4 | 212 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26165391 | DERIVED |
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| HZT-501 vs Ibuprofen: The Incidence Rate of NSAID-associated Serious Gastrointestinal Complications. | Trial comparisons |
| HZT-501 vs Ibuprofen: Number of Subjects Who Develop Endoscopically-diagnosed Upper Gastrointestinal Ulcers Confirmed by Endoscopy. | Trial comparisons |
| HZT-501 vs Ibuprofen: Number of Subjects Who Develop Endoscopically-diagnosed Duodenal Ulcers During the 24-week Treatment Period. | Trial comparisons |
| HZT-501 vs Ibuprofen: Number of Subjects Who Develop Endoscopically-diagnosed Gastric Ulcers During the 24-week Treatment Period. | Trial comparisons |
| HZT-501 vs Ibuprofen: 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/NCT00450658
GET https://conductscience.org/api/trials/v1/NCT00450658/events?page=2