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NCT00645398 · ClinicalTrials.gov registry record · Phase 3

A Study of the Efficacy and Safety of Pregabalin for the Treatment of Fibromyalgia

A Phase 3 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.

Completed
Registry status
Phase 3
Development phase
751
Enrollment target

NCT00645398 is a Phase 3 study that has completed, run by Pfizer's Upjohn has merged with Mylan to form Viatris. The registered enrollment target is 751 participants.

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The verdict

NCT00645398, a Phase 3 study, has completed, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.

COMPLETED
Registry status
Phase 3
Development phase
751 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the efficacy and safety of pregabalin versus placebo for the symptomatic relief of pain associated with fibromyalgia. If this objective is met, then the second objective will be to evaluate the efficacy and safety of pregabalin versus placebo for the management of fibromyalgia (pain, patient global assessment, and functional status). Additionally, the study will evaluate the efficacy of pregabalin versus placebo to improve sleep, fatigue, and mood disturbance associated with fibromyalgia.

Interventions

  • DRUG Placebo
  • DRUG Pregabalin

Trial Details

FieldValue
Enrollment Target 751 participants
Start Date 2004-09
Est. Completion 2005-06
Phase Phase 3

What the Registry Record Tells You About NCT00645398

The ClinicalTrials.gov registry entry for NCT00645398 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 751 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer's Upjohn has merged with Mylan to form Viatris, which has 158 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00645398 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00645398 about?

NCT00645398 is a clinical study titled "A Study of the Efficacy and Safety of Pregabalin for the Treatment of Fibromyalgia". The purpose of this study is to evaluate the efficacy and safety of pregabalin versus placebo for the symptomatic relief of pain associated with fibromyalgia. If this objective is met, then the second objective will be to evaluate the efficacy and safety of pregabalin versus placebo for the manageme...

What is the current status of trial NCT00645398?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 751 participants. The study started on 2004-09. Estimated completion is 2005-06.

What interventions are being tested in trial NCT00645398?

The interventions under investigation include: Placebo (DRUG), Pregabalin (DRUG).

Who is sponsoring clinical trial NCT00645398?

This trial is sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris, which has 158 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.