Pregabalin In Adolescent Patients With Fibromyalgia

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01020526
First received: November 23, 2009
Last updated: September 8, 2014
Last verified: September 2014
  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:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Pain Numeric Rating Scale (NRS) [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 106
Study Start Date: September 2010
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (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
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: NCT01020526

Locations
United States, California
Pfizer Investigational Site
Los Angeles, California, United States, 90027
Pfizer Investigational Site
Santa Ana, California, United States, 92705
United States, Florida
Pfizer Investigational Site
Coral Gables, Florida, United States, 33134
Pfizer Investigational Site
North Miami Beach, Florida, United States, 33162
Pfizer Investigational Site
Orlando, Florida, United States, 32806
United States, Georgia
Pfizer Investigational Site
Columbus, Georgia, United States, 31909
United States, Kentucky
Pfizer Investigational Site
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Pfizer Investigational Site
Worcester, Massachusetts, United States, 01655
United States, Ohio
Pfizer Investigational Site
Akron, Ohio, United States, 44308
Pfizer Investigational Site
Boardman, Ohio, United States, 44512
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45219
Pfizer Investigational Site
Columbus, Ohio, United States, 43205
United States, South Carolina
Pfizer Investigational Site
Charleston, South Carolina, United States, 29425
Pfizer Investigational Site
Myrtle Beach, South Carolina, United States, 29572
United States, Utah
Pfizer Investigational Site
Salt Lake City, Utah, United States, 84102
Czech Republic
Pfizer Investigational Site
Ricany, Czech Republic, 25101
India
Pfizer Investigational Site
Secunderabad, Andhra Pradesh, India, 500 003
Pfizer Investigational Site
Mangalore, Karnataka, India, 575002
Pfizer Investigational Site
Nagpur, Maharashtra, India, 440010
Pfizer Investigational Site
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: September 8, 2014
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
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 18, 2014