A Study For Pregabalin In Patients With Fibromyalgia

NCT01387607

Last updated date
Study Location
Department of Rheumatism And Immunity, The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233000, China
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Fibromyalgia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male or female patients, at least 18 years of age

- Meeting the ACR (America College of Rheumatology) criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites)

- At screening (V1) and randomization (V2), patients must have a score of no less than 40 mm on the Pain Visual Analog Scale (VAS)

- At randomization (V2), at least 4 pain diaries must be completed satisfactorily within the last 7 days and the average pain score must be no less than 4

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Patients with no less than 30% decrease on the Pain Visual Analog Scale (VAS) at
randomization (V2) as compared to screening (V1)


- Patients with other severe pain due to other conditions (eg, DPN or PHN) that may
confound assessment or self-evaluation of the pain associated with fibromyalgia


- Patients with any widespread inflammatory musculoskeletal disorders, widespread
rheumatic diseases other than fibromyalgia, active infections, or untreated endocrine
disorders


- CLcr less than 60 mL/min (estimated from serum creatinine)

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study For Pregabalin In Patients With Fibromyalgia
Official Title  ICMJE A 14-week, Randomized, Double-blind Placebo-controlled Study For Pregabalin In Subjects With Fibromyalgia
Brief Summary The purpose of this study is to evaluate the efficacy and tolerability of pregabalin compared with placebo for management of fibromyalgia in adults.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Fibromyalgia
Intervention  ICMJE
  • Drug: pregabalin
    Pregabalin capsule, 300-450mg/day, twice daily
  • Drug: placebo
    Placebo, twice daily
Study Arms  ICMJE
  • Experimental: Pregabalin
    Intervention: Drug: pregabalin
  • Placebo Comparator: Placebo
    Matched placebo
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 9, 2016)
343
Original Estimated Enrollment  ICMJE
 (submitted: June 30, 2011)
324
Actual Study Completion Date  ICMJE October 31, 2016
Actual Primary Completion Date October 31, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female patients, at least 18 years of age
  • Meeting the ACR (America College of Rheumatology) criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites)
  • At screening (V1) and randomization (V2), patients must have a score of no less than 40 mm on the Pain Visual Analog Scale (VAS)
  • At randomization (V2), at least 4 pain diaries must be completed satisfactorily within the last 7 days and the average pain score must be no less than 4

Exclusion Criteria:

  • Patients with no less than 30% decrease on the Pain Visual Analog Scale (VAS) at randomization (V2) as compared to screening (V1)
  • Patients with other severe pain due to other conditions (eg, DPN or PHN) that may confound assessment or self-evaluation of the pain associated with fibromyalgia
  • Patients with any widespread inflammatory musculoskeletal disorders, widespread rheumatic diseases other than fibromyalgia, active infections, or untreated endocrine disorders
  • CLcr less than 60 mL/min (estimated from serum creatinine)
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01387607
Other Study ID Numbers  ICMJE A0081241
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date September 2017

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