Study Of A Controlled Release Formulation Of Pregabalin In Fibromyalgia Patients

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NCT01271933

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Study Location
Andrew O. Schreiber, MD
Orange, California, 92868, United States
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Contact
1-800-718-1021
[email protected]
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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

- Patients must have fibromyalgia.

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


- Patients with other painful conditions cannot participate.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Of A Controlled Release Formulation Of Pregabalin In Fibromyalgia Patients
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Fibromyalgia
Intervention  ICMJE
  • Drug: pregabalin
    controlled release tablet; 165-495 mg/day; given once daily
  • Drug: placebo
    matching placebo tablet; given once daily
Study Arms  ICMJE
  • Experimental: Pregabalin
    Intervention: Drug: pregabalin
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
Publications * Arnold LM, Arsenault P, Huffman C, Patrick JL, Messig M, Chew ML, Sanin L, Scavone JM, Pauer L, Clair AG. Once daily controlled-release pregabalin in the treatment of patients with fibromyalgia: a phase III, double-blind, randomized withdrawal, placebo-controlled study. Curr Med Res Opin. 2014 Oct;30(10):2069-83. doi: 10.1185/03007995.2014.928275. Epub 2014 Jun 27. Erratum in: Curr Med Res Opin. 2017 Apr;33(4):795-796.

*   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: August 14, 2018)		441
Original Estimated Enrollment  ICMJE
 (submitted: January 5, 2011)		290
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients must have fibromyalgia.

Exclusion Criteria:

  • Patients with other painful conditions cannot participate.
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 Canada,   India,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01271933
Other Study ID Numbers  ICMJE A0081245
FIBROMYALGIA ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
Study Sponsor  ICMJE Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date August 2018

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