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Study Of A Controlled Release Formulation Of Pregabalin In Fibromyalgia Patients

NCT01271933 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 441

Last updated 2021-01-22

Study results available
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Summary

The purpose of this study is to evaluate the efficacy and safety of a controlled release formulation of pregabalin administered once daily as compared to placebo in the treatment of fibromyalgia. All patients will receive pregabalin; half of the patients will receive placebo at some point in the study.

Conditions

  • Fibromyalgia

Interventions

DRUG

pregabalin

controlled release tablet; 165-495 mg/day; given once daily

DRUG

placebo

matching placebo tablet; given once daily

Sponsors & Collaborators

  • Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • United States
  • Canada
  • India
  • Taiwan

Study Locations

More Related Trials

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 NCT01271933 on ClinicalTrials.gov