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NCT00984815 · ClinicalTrials.gov registry record · Phase 3

Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-steroidal Anti-inflammatory Drug Treatment

A Phase 3 study, sponsored by Amgen.

Completed
Registry status
Phase 3
Development phase
86
Enrollment target

NCT00984815: Completed Phase 3 study, sponsored by Amgen.

NCT00984815 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 86 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00984815, a Phase 3 study, has completed, sponsored by Amgen.

COMPLETED
Registry status
Phase 3
Development phase
86 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the safety of long-term treatment with HZT-501, a fixed-dose combination oral tablet of 800 mg ibuprofen and 26.6 mg famotidine for patients that require long-term NSAID treatment.

Interventions

  • DRUG HZT-501

Trial Details

FieldValue
Enrollment Target 86 participants
Start Date 2009-09
Est. Completion 2011-07
Phase Phase 3
Amgen

558 total trials

What the finished NCT00984815 record still lists

NCT00984815 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 86 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower).

The record links to 0 conditions, and to 1 intervention - of which HZT-501 is the first listed.

NCT00984815 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00984815 about?

NCT00984815 is a clinical study titled "Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-steroidal Anti-inflammatory Drug Treatment". The purpose of this study is to evaluate the safety of long-term treatment with HZT-501, a fixed-dose combination oral tablet of 800 mg ibuprofen and 26.6 mg famotidine for patients that require long-term NSAID treatment.

What is the current status of trial NCT00984815?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 86 participants. The study started on 2009-09. Estimated completion is 2011-07.

What interventions are being tested in trial NCT00984815?

The interventions under investigation include: HZT-501 (DRUG).

Who is sponsoring clinical trial NCT00984815?

This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00984815's enrollment target sits among peer trials

86 1745th of 2000 higher than 254 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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Source: ClinicalTrials.gov NCT00984815, the US trial registry maintained by the National Library of Medicine. NCT00984815 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.