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Study Of A Controlled Release Formulation Of Pregabalin In Fibromyalgia Patients

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NCT01271933

Last updated on May 9, 2018
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FOR MORE INFORMATION
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.

NCT01271933
Pfizer
Completed
Study Of A Controlled Release Formulation Of Pregabalin In Fibromyalgia Patients

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Study Of A Controlled Release Formulation Of Pregabalin In Fibromyalgia Patients
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)
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Fibromyalgia
  • Drug: pregabalin
    controlled release tablet; 165-495 mg/day; given once daily
  • Drug: placebo
    matching placebo tablet; given once daily
  • Experimental: Pregabalin
    Intervention: Drug: pregabalin
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
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.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
777
July 2012
July 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients must have fibromyalgia.

Exclusion Criteria:

  • Patients with other painful conditions cannot participate.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   India,   Taiwan,   United States
 
 
NCT01271933
A0081245
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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