ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Patients must have met the inclusion criteria for the preceding fibromyalgia Study A0081180, and have received pregabalin/placebo under double-blind conditions.
- Patients may not participate in the study if they experienced a serious adverse event
during the previous fibromyalgia study A0081180 which was determined to be related to
the study medication by the investigator or sponsor.
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Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Pregabalin In Adolescent Patients With Fibromyalgia | |||
Official Title ICMJE | A 6-month, Open-label, Safety Trial Of Pregabalin In Adolescent Patients With Fibromyalgia | |||
Brief Summary | The main purpose of this study is to evaluate the long-term safety of pregabalin in adolescent patients who participated in the previous fibromyalgia study (A0081180) and who wish to recieve open-label pregabalin | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Non-Randomized Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Fibromyalgia | |||
Intervention ICMJE | Drug: pregabalin
Oral capsule 75-450 mg/day | |||
Study Arms ICMJE | Experimental: Pregabalin
Intervention: Drug: pregabalin | |||
Publications * | Arnold LM, Schikler KN, Bateman L, Khan T, Pauer L, Bhadra-Brown P, Clair A, Chew ML, Scavone J; Pregabalin Adolescent Fibromyalgia Study Group. Safety and efficacy of pregabalin in adolescents with fibromyalgia: a randomized, double-blind, placebo-controlled trial and a 6-month open-label extension study. Pediatr Rheumatol Online J. 2016 Jul 30;14(1):46. doi: 10.1186/s12969-016-0106-4. | |||
* 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 | 63 | |||
Original Estimated Enrollment ICMJE | 162 | |||
Actual Study Completion Date ICMJE | June 2015 | |||
Actual Primary Completion Date | June 2015 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 12 Years to 18 Years (Child, Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Czechia, India, United States | |||
Removed Location Countries | Czech Republic, Taiwan | |||
Administrative Information | ||||
NCT Number ICMJE | NCT01020526 | |||
Other Study ID Numbers ICMJE | A0081231 2010-020300-29 ( EudraCT Number ) | |||
Has Data Monitoring Committee | Yes | |||
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 |
| |||
PRS Account | Pfizer | |||
Verification Date | May 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |