Safety And Efficacy Of Lyrica (Regulatory Post Marketing Commitment Plan)

NCT01256593 | Completed Results FDA Drug

• 1 other identifier: A0081261
• Study Type: observational
• Target: 3,827
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this Investigation is to evaluate the safety and efficacy of Lyrica in medical practice. Also, occurrence of unknown and known adverse drug reactions (ADRs) in subjects treated with Lyrica will be monitored during the survey period, and whether an additional treatment outcome investigation and/or a post-marketing clinical study is required in the future will be determined.

Conditions

Neuralgia

Keywords

Lyrica; Regulatory Post Marketing Commitment Plan; Safety; Neuropathic Pain; Post Marketing Surveillance

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.

  13 weeks at maximum

Secondary Outcomes (10)

• Percentage of Participants With Serious Adverse Drug Reaction

  13 weeks at maximum

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

  13 weeks at maximum

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

  13 weeks at maximum

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

  13 weeks at maximum

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

  13 weeks at maximum

Study Arms (1)

Pregabalin (Lyrica) capsule

Patients administered "Pregabalin capsule".

Drug: Pregabalin (Lyrica) capsule

Interventions

Pregabalin (Lyrica) capsule DRUG

Lyrica® Capsules depending on the investigator prescription. Frequency and duration are according to Package Insert as follows. "The usual adult dosage for oral use begins at 150 mg/day of pregabalin in twice daily, and should be gradually increased to 300 mg/day over 1 week or more and should be orally administered twice daily. Dosage should be adjusted, depending on age or symptoms. However, the daily maximum dose should not be beyond 600 mg, and should be orally administered twice daily".

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

Pregabalin (Lyrica) capsule

Eligibility Criteria

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

Study Population

The patients whom an investigator involving A0081261 prescribes the Lyrica capsule.

You may qualify if:

• Patients need to be administered Lyrica® in order to be enrolled in the surveillance.

You may not qualify if:

• Patients not administered Lyrica®.

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

Neuralgia

Interventions

Pregabalin; Capsules

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

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: December 7, 2010
• First Posted: December 8, 2010
• Study Start: February 5, 2011
• Primary Completion: July 31, 2017
• Study Completion: July 31, 2017
• Last Updated: September 15, 2023
• Results First Posted: May 7, 2019

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share