Clinical Trial: Phase 2 Study of TD-9855 to Treat Fibromyalgia
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase 2 Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of TD-9855 in Patients With Fibromyalgia (FM)
Brief Summary: The purpose of this study study is to determine whether TD-9855 is effective in treating patients with fibromyalgia.
Detailed Summary:
Sponsor: Theravance Biopharma R & D, Inc.
Current Primary Outcome: Percent change in mean pain score based on the mean of the last 7 daily pain NRS scores from the daily pain diaries [ Time Frame: Up to 9 weeks ]
Original Primary Outcome: Change in Pain Numerical Rating Scale [ Time Frame: Between baseline (Day 1) and study drug completion (Day 43) ]
Current Secondary Outcome:
- Fibromyalgia Impact Questionnaire (FIQ) [ Time Frame: From Run-In through End of Study (Day 63) ]
- Patient Global Impression of Change (PGIC) [ Time Frame: From Baseline through End of Study (Day 63) ]
Original Secondary Outcome:
- Change in the Patient Global Impression of Change [ Time Frame: Between baseline (Day 1) and study drug completion (Day 43) ]
- Change in the Fibromyalgia Impact Questionnaire score [ Time Frame: Between baseline (Day 1) and study drug completion (Day 43) ]
Information By: Theravance Biopharma Antibiotics, Inc.
Dates:
Date Received: September 20, 2012
Date Started: November 2012
Date Completion:
Last Updated: September 8, 2014
Last Verified: September 2014
