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

NCT01773993 | Completed Results

• 1 other identifier: A0081282
• Study Type: observational
• Target: 534
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Pain Associated With Fibromyalgia

Keywords

Lyrica; pregabalin; Good post marketing practice; Post Marketing Surveillance; Regulatory Post Marketing Commitment Plan; Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Adverse Drug Reaction

  An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Relatedness to LYRICA Capsules was assessed by the physician.

  From Week 1 to 52 weeks at maximum

Secondary Outcomes (13)

• Percentage of Participants With Serious Adverse Drug Reaction

  From Week 1 to52 weeks

• Percentage of Participants With Adverse Drug Reaction Unexpected From Japanese Package Insert

  From Week 1 to 52 weeks

• Number of Participants With Adverse Drug Reactions Related to Peripheral Edema or Other Edema-related Events

  From Week 1 to 52 weeks

• Number of Participants With Adverse Drug Reactions Related to Dizziness, Somnolence, Loss of Consciousness, Syncope, and Potential for Accidental Injury

  From Week 1 to 52 weeks

• Number of Participants With Adverse Drug Reactions Related to Vision-related Events

  From Week 1 to 52 weeks

Study Arms (1)

Pregabalin

Subjects who are treated with pregabalin

Drug: Pregabalin

Interventions

Pregabalin DRUG

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.

Also known as: Lyrica® Capsules 25 mg, Lyrica® Capsules 75 mg, Lyrica® Capsules 150 mg

Pregabalin

Eligibility Criteria

• Age: 0 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Primary care clinic and hospital for Fibromyalgia

You may qualify if:

• Clinical diagnosis of Fibromyalgia
• Pregabalin naive patient

You may not qualify if:

• Clinical diagnosis of neuropathic pain

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Fibromyalgia

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2013
• First Posted: January 23, 2013
• Study Start: February 1, 2013
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: October 10, 2023
• Results First Posted: May 3, 2019

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share