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NCT00613106 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 179
- Enrollment target
NCT00613106: Completed Phase 3 study, sponsored by Amgen.
NCT00613106 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 179 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00613106, a Phase 3 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 179 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety of long-term treatment with HZT-501.
Primary Outcome
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 seri
Interventions
- DRUG Ibuprofen
- DRUG HZT-501
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 179 participants |
| Start Date | 2007-09 |
| Est. Completion | 2008-10 |
| Phase | Phase 3 |
What the finished NCT00613106 record still lists
NCT00613106 is an interventional study that assigns participants to a tested intervention. The registered 179 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Ibuprofen is the first listed.
NCT00613106 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00613106 about?
NCT00613106 is a clinical study titled "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)". The purpose of this study is to evaluate the safety of long-term treatment with HZT-501.
What is the current status of trial NCT00613106?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 179 participants. The study started on 2007-09. Estimated completion is 2008-10.
What interventions are being tested in trial NCT00613106?
The interventions under investigation include: Ibuprofen (DRUG), HZT-501 (DRUG).
Who is sponsoring clinical trial NCT00613106?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00613106's enrollment target sits among peer trials
179 1437th of 2000 higher than 564 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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