Pramipexole ER vs. Placebo in Fibromyalgia
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- The Change in the Weekly Mean of the 24 Hour Average Pain Score From a Daily Diary [ Time Frame: Baseline and 24 Weeks ] [ Designated as safety issue: No ]Measured by the 11 point Likert scale with 0 = no pain and 10 = worst possible pain (assessed between baseline and the end of maintenance phase).
|Study Start Date:||July 2008|
|Primary Completion Date:||November 2008 (Final data collection date for primary outcome measure)|
Experimental: Pramipexole ER
0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening
|Drug: pramipexole ER|
Placebo Comparator: Placebo
Placebo tablets, once daily in the evening
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|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|