Study Of A Controlled Release Formulation Of Pregabalin In Fibromyalgia Patients

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. Identifier: NCT01271933
Recruitment Status : Completed
First Posted : January 7, 2011
Last Update Posted : October 1, 2013
Information provided by (Responsible Party):

Brief 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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Drug: pregabalin Drug: placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 777 participants
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)
Study Start Date : March 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia
Drug Information available for: Pregabalin
U.S. FDA Resources

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Patients must have fibromyalgia.

Exclusion Criteria:

  • Patients with other painful conditions cannot participate.

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 identifier (NCT number): NCT01271933

  Show 51 Study Locations
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Pfizer Identifier: NCT01271933     History of Changes
Other Study ID Numbers: A0081245
First Posted: January 7, 2011    Key Record Dates
Last Update Posted: October 1, 2013
Last Verified: September 2013

Keywords provided by Pfizer:

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