Adolescent Fibromyalgia Study
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01020474
First received: November 23, 2009
Last updated: January 9, 2015
Last verified: January 2015
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Purpose
This study will compare pregabalin with placebo over a 15 week period in adolescents with fibromyalgia aged 12-17 years to evaluate the safety and efficacy of pregabalin.
| Condition | Intervention | Phase |
|---|---|---|
|
Fibromyalgia |
Drug: placebo Drug: pregabalin (Lyrica) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A 15 Week, Randomized, Double Blind, Parallel-group, Placebo-controlled, Flexible-dose, Safety And Efficacy Study Of Pregabalin In Adolescents (12-17 Years Old) With Fibromyalgia |
Resource links provided by NLM:
MedlinePlus related topics:
Fibromyalgia
Drug Information available for:
Pregabalin
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- change from baseline to week 15 in mean pain diary score [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- change from baseline to week 15 in mean sleep quality diary score [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
- Pain Numeric Rating Scale (Pain-NRS) [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
- Patient Global Impression of Change [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
- weekly change from baseline in mean pain score at weeks 1-15 [ Time Frame: weeks 1-15 ] [ Designated as safety issue: No ]
- weekly change from baseline in mean sleep quality score at week 1-15 [ Time Frame: weeks 1-15 ] [ Designated as safety issue: No ]
| Enrollment: | 107 |
| Study Start Date: | May 2010 |
| Study Completion Date: | December 2014 |
| Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo |
Drug: placebo
matching placebo capsules twice daily.
|
| Experimental: drug-pregabalin |
Drug: pregabalin (Lyrica)
75-450mg/day pregabalin dose optimised at start of study
Other Name: pregabalin (Lyrica)
|
Eligibility| Ages Eligible for Study: | 12 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of fibromyalgia
- 12-17 years of age
Exclusion Criteria:
- Patients with other pain conditions
- Previous treatment with pregabalin
- Patients taking excluded medication
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01020474
Show 36 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01020474
Show 36 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01020474 History of Changes |
| Other Study ID Numbers: | A0081180, 2010-019521-34 |
| Study First Received: | November 23, 2009 |
| Last Updated: | January 9, 2015 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
juvenile primary fibromyalgia syndrome pediatric fibromyalgia pregabalin and Lyrica |
Additional relevant MeSH terms:
|
Fibromyalgia Myofascial Pain Syndromes Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases Pregabalin Analgesics Anticonvulsants |
Calcium Channel Blockers Cardiovascular Agents Central Nervous System Agents Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Sensory System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on February 27, 2015