N/A
Completed N=891
Safety And Efficacy In Long Term Use Of Lyrica (Regulatory Post Marketing Commitment Plan)
Source: ClinicalTrials.gov NCT01279850 ↗Enrolled (actual)
891
Serious AEs
2.8%
Results posted
May 2019
Primary outcomePrimary: Percentage of Participants With Adverse Drug Reaction — 12.75 Percentage of Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Adverse Drug Reaction |
12.75 | — |
| SECONDARY Percentage of Participants With Serious Adverse Drug Reaction |
0.25 | — |
| SECONDARY Percentage of Participants With Adverse Drug Reaction Unexpected From Japanese Package Insert |
0.50 | — |
| SECONDARY Number of Participants With Adverse Drug Reactions Related to Peripheral Edema or Other Edema-related Events |
14 | — |
| SECONDARY Number of Participants With Adverse Drug Reactions Related to Dizziness, Somnolence, Loss of Consciousness, Syncope, and Potential for Accidental Injury |
65 | — |
| SECONDARY Number of Participants With Adverse Drug Reactions Related to Vision-related Events |
4 | — |
| SECONDARY Clinical Effectiveness Rate |
91.0 | — |
| SECONDARY Change From Baseline in Participant-rated Pain Score at Week 104 |
-4.4 | — |
| SECONDARY Change From Baseline in Participant-rated Sleep Interference Score at Week 104 |
-3.9 | — |
| SECONDARY Patient's Impression (PGIC) at Week 104 |
95; 223; 183; 71; 3; 2 | — |
| SECONDARY Physician's Impression (CGIC) at Week 104 |
108; 275; 179; 93; 7; 0 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01279850). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.