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Pramipexole ER vs. Placebo in Fibromyalgia

Fibromyalgia Clinical Trial

Official title:
A Randomized, Double-blind, Placebo-controlled, Dose Titration Efficacy and Safety Study of Pramipexole ER (0.75 to 4.5 mg) Administered Orally Once Daily Versus Placebo Over a 16-week Maintenance Phase in Patients Diagnosed With Fibromyalgia, as Assessed by the American College of Rheumatology (ACR) Criteria Followed by a 24-week Open-label Extension Phase

Clinical Trial Summary

The primary objective of this study is to assess the efficacy and safety of an extended-release (ER) formulation of pramipexole in comparison with placebo for the treatment of fibromyalgia.

The objective of the open-label phase is to assess the safety profile and effect of Pramipexole (PPX) extended-release (ER) in fibromyalgia patients over a 24-week period.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00689052
Study type Interventional
Source Boehringer Ingelheim
Contact
Status Terminated
Phase Phase 2
Start date July 2008
View Details
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