Ignite Creation Date:
2025-12-24 @ 2:40 PM
Ignite Modification Date:
2026-04-16 @ 11:41 PM
Study NCT ID:
NCT02187159
Status:
COMPLETED
Last Update Posted:
2020-11-09
First Post:
2014-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Treatment of Pain Associated With Fibromyalgia
Sponsor:
Daiichi Sankyo
Organization:
Study Overview
Official Title:
A Randomized, Double-Blind, Placebo- and Active-Controlled Study of DS-5565 for Treatment of Pain Associated With Fibromyalgia
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2013-005163-10 | EUDRACT_NUMBER | None | View |