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Treatment of Pain Associated With Fibromyalgia

NCT02187471 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1301

Last updated 2020-11-09

Study results available
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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 subject that best describes his or her worst pain over the previous 24 hours.

Conditions

  • Pain Associated With Fibromyalgia

Interventions

DRUG

DS-5565

DS-5565 15 mg QD or BID; tablet for oral use

DRUG

Pregabalin

Pregabalin capsule for oral use; 75 mg capsule for one week, then 150 mg capsule

DRUG

Placebo tablet

Placebo tablet for oral use, matching DS-5565 tablet

DRUG

Placebo capsule

Placebo capsule for oral use, matching pregabalin capsule

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Leader · Daiichi Sankyo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-16
Primary Completion
2017-01-06
Completion
2017-01-12

Countries

  • United States
  • Argentina
  • Austria
  • Belarus
  • Belgium
  • Chile
  • Colombia
  • Israel
  • Mexico
  • Poland
  • Portugal
  • Slovenia
  • Spain
  • Switzerland

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02187471 on ClinicalTrials.gov