Trial · NCT00613106
Double-Blind Follow-on Safety Study of HZT-501 (Ibuprofen 800 mg/Famotidine 26.6 mg) in Subjects Who Have Completed Participation in HZ-CA-301 (NCT00450658) or HZ-CA-303 (NCT00450216)
NCT00613106, Phase 3, Completed, Amgen; results first posted 2011-06-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Double-Blind Follow-on Safety Study of HZT-501 (Ibuprofen 800 mg/Famotidine 26.6 mg) in Subjects Who Have Completed Participation in HZ-CA-301 (NCT00450658) or HZ-CA-303 (NCT00450216). Trials, record NCT00613106. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00613106
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Double-Blind Follow-on Safety Study of HZT-501 (Ibuprofen 800 mg/Famotidine 26.6 mg) in Subjects Who Have Completed Participation in HZ-CA-301 (NCT00450658) or HZ-CA-303 (NCT00450216)
- NCT number
- NCT00613106
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 179 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Chronic Low Back Pain, Chronic Regional Pain Syndrome, Chronic Soft Tissue Pain
- Interventions
- HZT-501, Ibuprofen
- First posted
- 2008-02-12
- Last updated
- 2024-12-17
- Results first posted
- 2011-06-17
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment Emergent Adverse Events | 28 weeks | The objective of this study was to evaluate the long term safety of HZT-501 (ibuprofen 800 mg/famotidine 26.6 mg). No efficacy analyses were planned or performed. Adverse event information was elicited from each participant by indirect questioning using a non-leading question, such as "Has anything bothered you since your last visit or is anything bothering you now?" Adverse event data may also have been volunteered by the participant to the investigator or designee. Physicians assessed the seriousness, severity and causality of each adverse event. |
Source ClinicalTrials.gov
Outcomes1
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 Treatment Emergent Adverse Events | 28 weeks | participants | NUMBER |
Source ClinicalTrials.gov
Results by group2
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 Treatment Emergent Adverse Events | HZT-501 (Ibuprofen/Famotidine) | 55 | participants | ||
| Number of Participants With Treatment Emergent Adverse Events | Ibuprofen | 16 | 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 (Ibuprofen/Famotidine) | 132 | |
| Overall Study | STARTED | Ibuprofen | 47 | |
| Overall Study | COMPLETED | HZT-501 (Ibuprofen/Famotidine) | 112 | |
| Overall Study | COMPLETED | Ibuprofen | 38 | |
| Overall Study | NOT COMPLETED | HZT-501 (Ibuprofen/Famotidine) | 20 | |
| Overall Study | NOT COMPLETED | Ibuprofen | 9 |
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 | anemia | Blood and lymphatic system disorders | HZT-501 (Ibuprofen/Famotidine) | 2 | 132 | |
| other | anemia | Blood and lymphatic system disorders | Ibuprofen | 0 | 47 | |
| other | cataract | Eye disorders | HZT-501 (Ibuprofen/Famotidine) | 0 | 132 | |
| other | cataract | Eye disorders | Ibuprofen | 1 | 47 | |
| other | abdominal pain upper | Gastrointestinal disorders | HZT-501 (Ibuprofen/Famotidine) | 2 | 132 | |
| other | abdominal pain upper | Gastrointestinal disorders | Ibuprofen | 0 | 47 | |
| other | abdominal tenderness | Gastrointestinal disorders | HZT-501 (Ibuprofen/Famotidine) | 0 | 132 | |
| other | abdominal tenderness | Gastrointestinal disorders | Ibuprofen | 1 | 47 | |
| other | constipation | Gastrointestinal disorders | HZT-501 (Ibuprofen/Famotidine) | 2 | 132 | |
| other | constipation | Gastrointestinal disorders | Ibuprofen | 0 | 47 |
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 (Ibuprofen/Famotidine) | ||
| Total, all-cause mortality | Ibuprofen | ||
| Total, other adverse events | HZT-501 (Ibuprofen/Famotidine) | 55 | 132 |
| Total, other adverse events | Ibuprofen | 16 | 47 |
| Total, serious adverse events | HZT-501 (Ibuprofen/Famotidine) | 3 | 132 |
| Total, serious adverse events | Ibuprofen | 2 | 47 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| HZT-501 (Ibuprofen/Famotidine) vs Ibuprofen: Number of Participants With Treatment Emergent Adverse Events | Trial comparisons |
| HZT-501 (Ibuprofen/Famotidine) 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/NCT00613106
GET https://conductscience.org/api/trials/v1/NCT00613106/events?page=2