A Study to Assess the Analgesic Efficacy and Safety of ASP0819 in Patients With Fibromyalgia

NCT03056690 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2024-10-29

Study results available
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Summary

This study assessed analgesic efficacy of ASP0819 relative to placebo as well as the safety and tolerability.

This study assessed treatment differences in physical function as well as the improvements in overall subject status (e.g., fibromyalgia symptoms and global functioning) of ASP0819 relative to placebo.

Conditions

  • Fibromyalgia

Interventions

DRUG

ASP0819

Oral capsule

DRUG

Placebo

Oral capsule

Sponsors & Collaborators

  • Astellas Pharma Global Development, Inc.

    lead INDUSTRY

Principal Investigators

  • Senior Medical Director · Astellas Pharma Global Development, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-20
Primary Completion
2018-02-27
Completion
2018-02-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

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 NCT03056690 on ClinicalTrials.gov