Pregabalin In Adolescent Patients With Fibromyalgia
This study is currently recruiting participants.
Verified April 2013 by Pfizer
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01020526
First received: November 23, 2009
Last updated: April 29, 2013
Last verified: April 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Fibromyalgia |
Drug: pregabalin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A 6-Month, Open-Label, Safety Trial Of Pregabalin In Adolescent Patients 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:
- Primary Efficacy Endpoint- Pain Numeric Rating Scale (NRS) [ Time Frame: 6 month ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 162 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | November 2014 |
| Estimated Primary Completion Date: | November 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Pregabalin |
Drug: pregabalin
Oral capsule 75-450 mg/day
|
Eligibility| Ages Eligible for Study: | 12 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients must have met the inclusion criteria for the preceding fibromyalgia Study A0081180, and have received pregabalin/placebo under double-blind conditions.
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01020526
Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Locations
| United States, California | |
| Pfizer Investigational Site | Recruiting |
| Los Angeles, California, United States, 90027 | |
| Pfizer Investigational Site | Terminated |
| Santa Ana, California, United States, 92705 | |
| United States, Florida | |
| Pfizer Investigational Site | Not yet recruiting |
| Coral Gables, Florida, United States, 33134 | |
| Pfizer Investigational Site | Recruiting |
| North Miami Beach, Florida, United States, 33162 | |
| Pfizer Investigational Site | Recruiting |
| Orlando, Florida, United States, 32806 | |
| United States, Georgia | |
| Pfizer Investigational Site | Not yet recruiting |
| Columbus, Georgia, United States, 31909 | |
| United States, Kentucky | |
| Pfizer Investigational Site | Recruiting |
| Louisville, Kentucky, United States, 40202 | |
| United States, Massachusetts | |
| Pfizer Investigational Site | Recruiting |
| Worcester, Massachusetts, United States, 01655 | |
| United States, Ohio | |
| Pfizer Investigational Site | Recruiting |
| Akron, Ohio, United States, 44308 | |
| Pfizer Investigational Site | Recruiting |
| Boardman, Ohio, United States, 44512 | |
| Pfizer Investigational Site | Recruiting |
| Cincinnati, Ohio, United States, 45219 | |
| Pfizer Investigational Site | Recruiting |
| Columbus, Ohio, United States, 43205 | |
| United States, South Carolina | |
| Pfizer Investigational Site | Recruiting |
| Charleston, South Carolina, United States, 29425 | |
| Pfizer Investigational Site | Terminated |
| Myrtle Beach, South Carolina, United States, 29572 | |
| United States, Utah | |
| Pfizer Investigational Site | Recruiting |
| Salt Lake City, Utah, United States, 84102 | |
| Czech Republic | |
| Pfizer Investigational Site | Recruiting |
| Ricany, Czech Republic, 25101 | |
| India | |
| Pfizer Investigational Site | Recruiting |
| Secunderabad, Andhra Pradesh, India, 500 003 | |
| Pfizer Investigational Site | Recruiting |
| Mangalore, Karnataka, India, 575002 | |
| Pfizer Investigational Site | Recruiting |
| Nagpur, Maharashtra, India, 440010 | |
| Pfizer Investigational Site | Recruiting |
| Lucknow, Uttar Pradesh, India, 226 018 | |
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: | NCT01020526 History of Changes |
| Other Study ID Numbers: | A0081231 |
| Study First Received: | November 23, 2009 |
| Last Updated: | April 29, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Fibromyalgia Myofascial Pain Syndromes Muscular Diseases Musculoskeletal Diseases Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases Pregabalin |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anticonvulsants |
ClinicalTrials.gov processed this record on May 22, 2013