Study Of A Controlled Release Formulation Of Pregabalin In Fibromyalgia Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01271933
First received: January 5, 2011
Last updated: September 23, 2013
Last verified: September 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Daily pain diary [ Time Frame: throughout study ] [ Designated as safety issue: No ]
  • Daily tiredness diary [ Time Frame: throughout study ] [ Designated as safety issue: No ]
  • Daily sleep diary [ Time Frame: throughout study ] [ Designated as safety issue: No ]
  • Numeric rating scale for pain [ Time Frame: screening, baseline, 6 and 19 weeks ] [ Designated as safety issue: No ]
  • Medical outcomes sleep study-sleep scale [ Time Frame: baseline, 6 and 19 weeks ] [ Designated as safety issue: No ]
  • Patient global impression of change [ Time Frame: baseline, 6 and 19 weeks ] [ Designated as safety issue: No ]
  • Short form 36 health survey (SF-36) [ Time Frame: baseline, 6 and 19 weeks ] [ Designated as safety issue: No ]
  • Hospital anxiety and depression scale [ Time Frame: baseline, 6 and 19 weeks ] [ Designated as safety issue: No ]
  • Fibromyalgia impact questionnaire [ Time Frame: baseline, 6 and 19 weeks ] [ Designated as safety issue: No ]
  • Multidimensional fatigue instrument [ Time Frame: baseline, 6 and 19 weeks ] [ Designated as safety issue: No ]
  • Benefit, satisfaction, willingness to continue measure [ Time Frame: baseline, 6 and 19 weeks ] [ Designated as safety issue: No ]
  • Work productivity and activity impairment [ Time Frame: baseline, 6 and 19 weeks ] [ Designated as safety issue: No ]
  • Actigraphy functional / sleep assessment [ Time Frame: screening, 3 and 11 weeks ] [ Designated as safety issue: No ]
  • Adverse events, suicidality assessment [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
  • Clinical laboratory tests, ECG, physical / neurological examinations, weight assessment, and vital signs. [ Time Frame: screening, 6 and 19 weeks ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have fibromyalgia.

Exclusion Criteria:

  • Patients with other painful conditions cannot participate.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01271933

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

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01271933     History of Changes
Other Study ID Numbers: A0081245
Study First Received: January 5, 2011
Last Updated: September 23, 2013
Health Authority: United States: Food and Drug Administration

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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on July 24, 2014