Special Investigation of Pregabalin for Fibromyalgia (Regulatory Post Marketing Commitment Plan)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01773993
Recruitment Status : Completed
First Posted : January 23, 2013
Last Update Posted : November 29, 2017
Information provided by (Responsible Party):

Brief Summary:
To collect the efficacy and safety information of Pregabalin on Fibromyalgia patients related to their appropriate use in daily practice.

Condition or disease Intervention/treatment
Pain Associated With Fibromyalgia Drug: Pregabalin

Detailed Description:
All the patients whom an investigator prescribes the first pregabalin should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Study Type : Observational
Actual Enrollment : 534 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Special Investigation Of Pregabalin For Fibromyalgia
Actual Study Start Date : February 27, 2013
Actual Primary Completion Date : July 31, 2017
Actual Study Completion Date : July 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia
Drug Information available for: Pregabalin
U.S. FDA Resources

Group/Cohort Intervention/treatment
Subjects who are treated with pregabalin
Drug: Pregabalin
The usual adult dosage for oral use begins at 150 mg/day of pregabalin twice daily, and should be gradually increased to 300 mg/day over 1 week or more and then maintained at 300-450 mg/day as needed. Dosage should be adjusted, depending on age or symptoms. However, the daily maximum dose should not be beyond 450 mg, and should be orally administered twice daily.
Other Name: Lyrica® Capsules 25 mg, Lyrica® Capsules 75 mg, Lyrica® Capsules 150 mg

Primary Outcome Measures :
  1. Number of Participants with Change from Baseline in Clinical Global Impression of Clinical Condition (CGI-C) at Month X [ Time Frame: 12 months ]
    The CGI-C scale measures a physician's global impression of a participant's clinical condition at final visit in terms of change relative to the start of treatment (CGI-C). At final visit, the participants CGI-C will be categorized into a three point scale as: improvement: CGI response of very much improved, much improved or minimally improved; no change: CGI response of no change; worsening: CGI response of very much worse, much worse or minimally worse

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Primary care clinic and hospital for Fibromyalgia

Inclusion Criteria:

  • Clinical diagnosis of Fibromyalgia
  • Pregabalin naive patient

Exclusion Criteria:

  • Clinical diagnosis of neuropathic pain

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01773993

Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Pfizer Identifier: NCT01773993     History of Changes
Other Study ID Numbers: A0081282
First Posted: January 23, 2013    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pfizer:
Good post marketing practice
Post Marketing Surveillance
Regulatory Post Marketing Commitment Plan

Additional relevant MeSH terms:
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs