Other Clinical Trial - Treatment of Pain Associated With Fibromyalgia

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial Summary

The main objective of this trial is to compare change in weekly average daily pain score (ADPS) from baseline to Week 13 in participants receiving either dose of DS-5565 versus placebo. Weekly ADPS is based on daily pain scores reported by the participant that best describes his or her worst pain over the previous 24 hours.

See also
Status	Clinical Trial	Phase
Completed	`NCT02146430` - Treatment of Pain Associated With Fibromyalgia	Phase 3
Completed	`NCT02187471` - Treatment of Pain Associated With Fibromyalgia	Phase 3
Completed	`NCT02234583` - An Open-Label Extension Study of DS-5565 for 52 Weeks in Pain Associated With Fibromyalgia	Phase 3
Completed	`NCT01773993` - Special Investigation of Pregabalin for Fibromyalgia (Regulatory Post Marketing Commitment Plan)

NCT number	NCT02187159
Study type	Interventional
Source	Daiichi Sankyo, Inc.
Contact
Status	Completed
Phase	Phase 3
Start date	November 2014
Completion date	July 7, 2016

Treatment of Pain Associated With Fibromyalgia

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms