Special Investigation of Pregabalin for Fibromyalgia (Regulatory Post Marketing Commitment Plan)
NCT01773993
Last updated date
ABOUT THIS STUDY
To collect the efficacy and safety information of Pregabalin on Fibromyalgia patients related
to their appropriate use in daily practice.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
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
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
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
Pain Associated With FibromyalgiaSpecial Investigation of Pregabalin for Fibromyalgia (Regulatory Post Marketing Commitment Plan)
NCT01773993
ALL GENDERS
0+
years
MULTIPLE SITES
Advanced Information
| 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 | 534 | ||||
| Original Estimated Enrollment | 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:
Exclusion Criteria:
| ||||
| Sex/Gender |
| ||||
| 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 |
| ||||
| IPD Sharing Statement |
| ||||
| Responsible Party | Pfizer | ||||
| Study Sponsor | Pfizer | ||||
| Collaborators | Not Provided | ||||
| Investigators |
| ||||
| PRS Account | Pfizer | ||||
| Verification Date | January 2019 | ||||