Clinical trial NCT01279850: Safety And Efficacy In Long Term Use Of Lyrica (Regulatory Post Marketing Commitment Plan)
Official title: SPECIAL INVESTIGATION OF LONG TERM USE OF LYRICA(REGULATORY POST MARKETING COMMITMENT PLAN)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuropathic Pain
Keywords: Lyrica
Regulatory Post Marketing Commitment Plan
Safety
Neuropathic Pain
Post Marketing Surveillance
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-01-19
Enrollment: 891
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients whom an investigator involving A0081262 prescribes the Lyrica capsule.

And the patients who are administered Lyrica for over 52 weeks (MAX 104 weeks).

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With Adverse Drug Reaction
timeFrame: From Week 1 to Week 104 at maximum
Secondary outcomes:
measure: Percentage of Participants With Serious Adverse Drug Reaction
timeFrame: From Week 1 to Week 104 at maximum
measure: Percentage of Participants With Adverse Drug Reaction Unexpected From Japanese Package Insert
timeFrame: From Week 1 to Week 104 at maximum
measure: Number of Participants With Adverse Drug Reactions Related to Peripheral Edema or Other Edema-related Events
timeFrame: From Week 1 to Week 104 at maximum
measure: Number of Participants With Adverse Drug Reactions Related to Dizziness, Somnolence, Loss of Consciousness, Syncope, and Potential for Accidental Injury
timeFrame: From Week 1 to Week 104 at maximum
measure: Number of Participants With Adverse Drug Reactions Related to Vision-related Events
timeFrame: From Week 1 to Week 104 at maximum
measure: Clinical Effectiveness Rate
timeFrame: At Week 104
measure: Change From Baseline in Participant-rated Pain Score at Week 104
timeFrame: Baseline and at Week 104
measure: Change From Baseline in Participant-rated Sleep Interference Score at Week 104
timeFrame: Baseline and at Week 104
measure: Patient's Impression (PGIC) at Week 104
timeFrame: At Week 104
measure: Physician's Impression (CGIC) at Week 104
timeFrame: At Week 104
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: