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NCT00325858 · ClinicalTrials.gov registry record · Phase 3

A Study Comparing the Effectiveness and Safety of Varying Dose Strengths (100, 200, 300 and 400 mg) of Extended-release Tramadol HCl With Placebo for the Treatment of Osteoarthritis(OA) of the Knee and/or Hip

A Phase 3 study, sponsored by Bausch Health Americas.

Completed
Registry status
Phase 3
Development phase
1,000
Enrollment target

NCT00325858: Completed Phase 3 study, sponsored by Bausch Health Americas.

NCT00325858 is a Phase 3 study that has completed, run by Bausch Health Americas. The registered enrollment target is 1,000 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (30% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00325858, a Phase 3 study, has completed, sponsored by Bausch Health Americas.

COMPLETED
Registry status
Phase 3
Development phase
1,000 participants
Enrollment target

Study Summary

The purpose of this study is to compare the effectiveness of multiple doses of once daily tramadol HCl ER (100, 200, 300 and 400 mg) to placebo in patients with moderate to severe pain due to OA. The study hypothesis is that tramadol HCl ER is safe and effective in the treatment of patients with moderate to severe pain due to OA.

Interventions

  • DRUG Tramadol HCl ER

Trial Details

FieldValue
Enrollment Target 1,000 participants
Start Date 2002-01
Est. Completion 2003-12
Phase Phase 3
Bausch Health Americas

168 total trials

What the finished NCT00325858 record still lists

NCT00325858 is an interventional study that assigns participants to a tested intervention. Its 1,000 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (30% higher).

The record links to 0 conditions, and to 1 intervention - of which Tramadol HCl ER is the first listed.

NCT00325858 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00325858 about?

NCT00325858 is a clinical study titled "A Study Comparing the Effectiveness and Safety of Varying Dose Strengths (100, 200, 300 and 400 mg) of Extended-release Tramadol HCl With Placebo for the Treatment of Osteoarthritis(OA) of the Knee and/or Hip". The purpose of this study is to compare the effectiveness of multiple doses of once daily tramadol HCl ER (100, 200, 300 and 400 mg) to placebo in patients with moderate to severe pain due to OA. The study hypothesis is that tramadol HCl ER is safe and effective in the treatment of patients with mod...

What is the current status of trial NCT00325858?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,000 participants. The study started on 2002-01. Estimated completion is 2003-12.

What interventions are being tested in trial NCT00325858?

The interventions under investigation include: Tramadol HCl ER (DRUG).

Who is sponsoring clinical trial NCT00325858?

This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00325858's enrollment target sits among peer trials

1,000 296th of 2000 higher than 1,689 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 NCT00325858, the US trial registry maintained by the National Library of Medicine. NCT00325858 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.