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Special Investigation of Pregabalin for Fibromyalgia (Regulatory Post Marketing Commitment Plan)

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NCT01773993

Last updated on January 19, 2020
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Study Location
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.
Pain Associated With Fibromyalgia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Clinical diagnosis of Fibromyalgia

- Pregabalin naive patient

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

- Clinical diagnosis of neuropathic pain

NCT01773993
Pfizer
Completed
Special Investigation of Pregabalin for Fibromyalgia (Regulatory Post Marketing Commitment Plan)

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Descriptive Information
Brief Title Special Investigation of Pregabalin for Fibromyalgia (Regulatory Post Marketing Commitment Plan)
Official Title SPECIAL INVESTIGATION OF PREGABALIN FOR FIBROMYALGIA
Brief Summary To collect the efficacy and safety information of Pregabalin on Fibromyalgia patients related to their appropriate use in daily practice.
Detailed Description All the patients whom an investigator prescribes the first pregabalin should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Primary care clinic and hospital for Fibromyalgia
Condition Pain Associated With Fibromyalgia
Intervention Drug: Pregabalin
The usual adult dosage for oral use begins at 150 mg/day of pregabalin twice daily, and should be gradually increased to 300 mg/day over 1 week or more and then maintained at 300-450 mg/day as needed. Dosage should be adjusted, depending on age or symptoms. However, the daily maximum dose should not be beyond 450 mg, and should be orally administered twice daily.
Other Name: Lyrica® Capsules 25 mg, Lyrica® Capsules 75 mg, Lyrica® Capsules 150 mg
Study Groups/Cohorts Pregabalin
Subjects who are treated with pregabalin
Intervention: Drug: Pregabalin
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 Completed
Actual Enrollment
 (submitted: November 13, 2017) 		534
Original Estimated Enrollment
 (submitted: January 18, 2013) 		500
Actual Study Completion Date July 2017
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Clinical diagnosis of Fibromyalgia
  • Pregabalin naive patient

Exclusion Criteria:

  • Clinical diagnosis of neuropathic pain
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01773993
Other Study ID Numbers A0081282
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da....
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date January 2019

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