This trial is active, not recruiting.

Condition neuropathic pain
Treatment pregabalin (lyrica) capsule
Sponsor Pfizer
Start date August 2011
End date June 2017
Trial size 1000 participants
Trial identifier NCT01279850, A0081262


The objective of this investigation is to evaluate the safety and efficacy of long term use with 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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Patients administered "Pregabalin capsule".
pregabalin (lyrica) capsule Lyrica® Capsules 25 mg, Lyrica® Capsules 75 mg, Lyrica® Capsules 150 mg
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".

Primary Outcomes

Number of Participants with Change from Baseline in Clinical Global Impression of Clinical Condition (CGI-C) at Month X
time frame: MAX 104 weeks

Eligibility Criteria

All participants of any age.

Inclusion Criteria: - Patients need to be administered by Lyrica for over 52 weeks in order to be enrolled in the surveillance. Exclusion Criteria: - Patients not administered Lyrica.

Additional Information

Official title Special Investigation Of Long Term Use Of Lyrica(Regulatory Post Marketing Commitment Plan)
Description Patients who fulfill criteria below: 1. Patients who have previously enrolled in A0081261. 2. Patients who have been administered Lyrica for more than 52 weeks.
Trial information was received from ClinicalTrials.gov and was last updated in March 2017.
Information provided to ClinicalTrials.gov by Pfizer.