A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin In Patients With Fibromyalgia
NCT00830128
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 Protocol A0081208, and must 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 A0081208; which was determined to be related to
the study medication by the investigator or the sponsor.
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Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin In Patients With Fibromyalgia | |||
Official Title ICMJE | An Open-Label Extension Safety And Efficacy Study Of Pregabalin (CI-1008) For The Treatment Of Fibromyalgia | |||
Brief Summary | This study will assess the safety and efficacy of the long-term use of pregabalin at doses up to 450 mg/day in patients with fibromyalgia who have completed 16 weeks of dosing in Study A0081208 (NCT00830167). | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Fibromyalgia | |||
Intervention ICMJE | Drug: pregabalin (Lyrica)
Dosage: 300-450 mg/day (150-225 mg twice daily), oral administration, Treatment duration: 52 weeks | |||
Study Arms ICMJE | Experimental: pregabalin (Lyrica)
Intervention: Drug: pregabalin (Lyrica) | |||
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 ICMJE | Completed | |||
Actual Enrollment ICMJE | 106 | |||
Original Estimated Enrollment ICMJE | 250 | |||
Actual Study Completion Date ICMJE | February 2011 | |||
Actual Primary Completion Date | February 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
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 | Japan | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00830128 | |||
Other Study ID Numbers ICMJE | A0081209 | |||
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 |
| |||
PRS Account | Pfizer | |||
Verification Date | April 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |