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Study Of A Controlled Release Formulation Of Pregabalin In Fibromyalgia Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01271933
First Posted: January 7, 2011
Last Update Posted: November 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  Purpose
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.

Condition Intervention Phase
Fibromyalgia Drug: pregabalin Drug: placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3 Double-Blind, Randomized, Placebo-Controlled, Safety And Efficacy Study Of Once Daily Controlled Release Pregabalin In The Treatment Of Patients With Fibromyalgia (Protocol A0081245)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Time to loss of therapeutic response based on pain response relative to baseline or patient discontinuation. [ Time Frame: 19 weeks ]

Secondary Outcome Measures:
  • Daily pain diary [ Time Frame: throughout study ]
  • Daily tiredness diary [ Time Frame: throughout study ]
  • Daily sleep diary [ Time Frame: throughout study ]
  • Numeric rating scale for pain [ Time Frame: screening, baseline, 6 and 19 weeks ]
  • Medical outcomes sleep study-sleep scale [ Time Frame: baseline, 6 and 19 weeks ]
  • Patient global impression of change [ Time Frame: baseline, 6 and 19 weeks ]
  • Short form 36 health survey (SF-36) [ Time Frame: baseline, 6 and 19 weeks ]
  • Hospital anxiety and depression scale [ Time Frame: baseline, 6 and 19 weeks ]
  • Fibromyalgia impact questionnaire [ Time Frame: baseline, 6 and 19 weeks ]
  • Multidimensional fatigue instrument [ Time Frame: baseline, 6 and 19 weeks ]
  • Benefit, satisfaction, willingness to continue measure [ Time Frame: baseline, 6 and 19 weeks ]
  • Work productivity and activity impairment [ Time Frame: baseline, 6 and 19 weeks ]
  • Actigraphy functional / sleep assessment [ Time Frame: screening, 3 and 11 weeks ]
  • Adverse events, suicidality assessment [ Time Frame: throughout study ]
  • Clinical laboratory tests, ECG, physical / neurological examinations, weight assessment, and vital signs. [ Time Frame: screening, 6 and 19 weeks ]

Enrollment: 777
Study Start Date: March 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pregabalin Drug: pregabalin
controlled release tablet; 165-495 mg/day; given once daily
Placebo Comparator: Placebo Drug: placebo
matching placebo tablet; given once daily

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have fibromyalgia.

Exclusion Criteria:

  • Patients with other painful conditions cannot participate.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01271933


  Show 51 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01271933     History of Changes
Other Study ID Numbers: A0081245
First Submitted: January 5, 2011
First Posted: January 7, 2011
Last Update Posted: November 17, 2017
Last Verified: September 2013

Keywords provided by Pfizer:
fibromyalgia
pain
pregabalin
Lyrica

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs