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NCT00347685 · ClinicalTrials.gov registry record · Phase 3

A One-year, Open-label Study to Assess the Safety and Effectiveness of Extended Release Tramadol HCl in the Treatment of Chronic, Non-malignant Pain.

A Phase 3 study, sponsored by Bausch Health Americas.

Completed
Registry status
Phase 3
Development phase
650
Enrollment target

NCT00347685: Completed Phase 3 study, sponsored by Bausch Health Americas.

NCT00347685 is a Phase 3 study that has completed, run by Bausch Health Americas. The registered enrollment target is 650 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (16% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00347685, a Phase 3 study, has completed, sponsored by Bausch Health Americas.

COMPLETED
Registry status
Phase 3
Development phase
650 participants
Enrollment target

Study Summary

The purpose of this study is to assess the safety of tramadol HCl ER following long-term treatment. The study hypothesis is that long-term treatment with tramadol HCl ER is safe and effective for the treatment of chronic, non-malignant pain.

Interventions

  • DRUG tramadol ER

Trial Details

FieldValue
Enrollment Target 650 participants
Start Date 2000-10
Est. Completion 2003-02
Phase Phase 3
Bausch Health Americas

168 total trials

What the finished NCT00347685 record still lists

NCT00347685 is an interventional study that assigns participants to a tested intervention. The registered 650 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 (16% lower).

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

NCT00347685 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00347685 about?

NCT00347685 is a clinical study titled "A One-year, Open-label Study to Assess the Safety and Effectiveness of Extended Release Tramadol HCl in the Treatment of Chronic, Non-malignant Pain.". The purpose of this study is to assess the safety of tramadol HCl ER following long-term treatment. The study hypothesis is that long-term treatment with tramadol HCl ER is safe and effective for the treatment of chronic, non-malignant pain.

What is the current status of trial NCT00347685?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 650 participants. The study started on 2000-10. Estimated completion is 2003-02.

What interventions are being tested in trial NCT00347685?

The interventions under investigation include: tramadol ER (DRUG).

Who is sponsoring clinical trial NCT00347685?

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 NCT00347685's enrollment target sits among peer trials

650 572nd of 2000 higher than 1,429 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 NCT00347685, the US trial registry maintained by the National Library of Medicine. NCT00347685 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.