A Study of the Efficacy and Safety of Pregabalin for the Treatment of Fibromyalgia

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00645398
First received: March 25, 2008
Last updated: April 23, 2008
Last verified: April 2008
  Purpose

The purpose of this study is to evaluate the efficacy and safety of pregabalin versus placebo for the symptomatic relief of pain associated with fibromyalgia. If this objective is met, then the second objective will be to evaluate the efficacy and safety of pregabalin versus placebo for the management of fibromyalgia (pain, patient global assessment, and functional status). Additionally, the study will evaluate the efficacy of pregabalin versus placebo to improve sleep, fatigue, and mood disturbance associated with fibromyalgia.


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, Investigator)
Primary Purpose: Treatment
Official Title: A 13-Week, Randomized, Double-Blind, Placebo-Controlled, Monotherapy Trial of Pregabalin (BID) in Patients With Fibromyalgia

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Endpoint mean pain score derived from the subject's daily pain diary [ Time Frame: Endpoint ] [ Designated as safety issue: No ]
  • Patient Global Assessment (Patient Global Impression of Change) at Termination Visit [ Time Frame: Weeks 5 and 13 ] [ Designated as safety issue: No ]
  • Change from baseline in functioning (score created from the Short Form-36 [SF-36] Social and Physical Functioning, Fibromyalgia Impact Questionnaire [FIQ]-Total Score, and Sheehan Disability Scale [SDS] Total Score) at Termination Visit [ Time Frame: Baseline and Weeks 5, 9, and 13 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in FIQ scores at Weeks 5, 9, and 13 [ Time Frame: Baseline and Weeks 5, 9, and 13 ] [ Designated as safety issue: No ]
  • Change from baseline in SDS scores at Weeks 5, 9, and 13 [ Time Frame: Baseline and Weeks 5, 9, and 13 ] [ Designated as safety issue: No ]
  • Change from baseline in Medical Outcomes Study (MOS)-Sleep Scale scores at Weeks 5, 9, and 13 [ Time Frame: Baseline and Weeks 5, 9, and 13 ] [ Designated as safety issue: No ]
  • Quality of Sleep Score from the Daily Sleep Diary [ Time Frame: Daily ] [ Designated as safety issue: No ]
  • Change from baseline in Multidimensional Assessment of Fatigue (MAF) scores at Weeks 5, 9, and 13 [ Time Frame: Baseline and Weeks 5, 9, and 13 ] [ Designated as safety issue: No ]
  • Change from baseline in Hospital Anxiety and Depression Scale (HADS) scores at Week 13 [ Time Frame: Baseline and Week 13 ] [ Designated as safety issue: No ]
  • Change from baseline in Short Form McGill Pain Questionnaire (SF-MPQ) scores at Weeks 5, 9, and 13 [ Time Frame: Screening, baseline, and Weeks 5, 9, and 13 ] [ Designated as safety issue: No ]
  • Change from baseline in Fibromyalgia Health Assessment Questionnaire (F-HAQ) scores at Weeks 9 and 13 [ Time Frame: Baseline and Weeks 9 and 13 ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Weeks 1, 2, 5, 9, 13, and at follow-up ] [ Designated as safety issue: Yes ]
  • Physical examination, including vital signs and weight [ Time Frame: Baseline and Week 5 (vital signs only) and 13 ] [ Designated as safety issue: Yes ]
  • Neurological examination [ Time Frame: Screening and Week 13 ] [ Designated as safety issue: Yes ]
  • Electrocardiogram [ Time Frame: Screening and Week 13 ] [ Designated as safety issue: Yes ]
  • Laboratory tests, including chemistry and hematology [ Time Frame: Baseline and Weeks 5, 13, and at follow-up ] [ Designated as safety issue: Yes ]
  • Urinalysis [ Time Frame: Baseline and Weeks 13 and at follow-up ] [ Designated as safety issue: Yes ]

Enrollment: 751
Study Start Date: September 2004
Study Completion Date: June 2005
Arms Assigned Interventions
Experimental: A Drug: Pregabalin
Pregabalin 150 mg BID taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).
Experimental: B Drug: Pregabalin
Pregabalin 225 mg BID taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).
Experimental: C Drug: Pregabalin
Pregabalin 300 mg BID taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).
Placebo Comparator: D Drug: Placebo
Matching placebo capsules taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).

  Eligibility

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

Inclusion Criteria:

  • Patients who met the American College of Rheumatology (ACR) criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites)
  • Patients who completed at least 4 pain diaries within the last 7 days and the average pain score must have been ≥4, and had a score of ≥40 mm on the Visual Analogue Scale (VAS) of the SF-MPQ at screening (Visit 1) and randomization (Visit 2)

Exclusion Criteria:

  • Patients with other severe pain that may confound assessment or self-evaluation of the pain associated with fibromyalgia
  • Patients with any inflammatory muscle or rheumatologic disease other than fibromyalgia, active infections, or untreated endocrine disorders
  • Patients with severe depression
  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: NCT00645398

  Show 103 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00645398     History of Changes
Other Study ID Numbers: A0081056
Study First Received: March 25, 2008
Last Updated: April 23, 2008
Health Authority: United States: Food and Drug Administration

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 29, 2014