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

March 25, 2008
April 23, 2008
September 2004
Not Provided
  • 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 ]
Same as current
Complete list of historical versions of study NCT00645398 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study of the Efficacy and Safety of Pregabalin for the Treatment of Fibromyalgia
A 13-Week, Randomized, Double-Blind, Placebo-Controlled, Monotherapy Trial of Pregabalin (BID) in Patients With Fibromyalgia

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Fibromyalgia
  • Drug: Pregabalin
    Pregabalin 225 mg BID taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).
  • Drug: Pregabalin
    Pregabalin 150 mg BID taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).
  • Drug: Pregabalin
    Pregabalin 300 mg BID taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).
  • Drug: Placebo
    Matching placebo capsules taken orally, 2 capsules BID for 13 weeks (1 week titration phase + 12 weeks fixed-dose phase).
  • Experimental: A
    Intervention: Drug: Pregabalin
  • Experimental: B
    Intervention: Drug: Pregabalin
  • Experimental: C
    Intervention: Drug: Pregabalin
  • Placebo Comparator: D
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
751
June 2005
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00645398
A0081056
Yes
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP