N/A
Completed N=534
Special Investigation of Pregabalin for Fibromyalgia (Regulatory Post Marketing Commitment Plan)
Pain Associated With Fibromyalgia
Source: ClinicalTrials.gov NCT01773993 ↗
Enrolled (actual)
534
Serious AEs
0.8%
Results posted
May 2019
Primary outcomePrimary: Percentage of Participants With Adverse Drug Reaction — 25.45 Percentage of Participants
Summary
To collect the efficacy and safety information of Pregabalin on Fibromyalgia patients related to their appropriate use in daily practice.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Adverse Drug Reaction |
25.45 | — |
| SECONDARY Percentage of Participants With Serious Adverse Drug Reaction |
0.20 | — |
| SECONDARY Percentage of Participants With Adverse Drug Reaction Unexpected From Japanese Package Insert |
3.41 | — |
| SECONDARY Number of Participants With Adverse Drug Reactions Related to Peripheral Edema or Other Edema-related Events |
6 | — |
| 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 |
5 | — |
| SECONDARY Change From Baseline in Pain Score at Week 52 |
-2.4 | — |
| SECONDARY Change From Baseline in Quality of Sleep Score at Week 52 |
-1.4 | — |
| SECONDARY Patient's Impression (PGIC) at Week 52 |
34; 79; 119; 65; 6; 3 | — |
| SECONDARY Physician's Impression (CGIC) at Week 52 |
45; 105; 121; 59; 4; 2 | — |
| SECONDARY Change From Baseline in Patient Health Questionnaire (PHQ-9) Score at Week 52 |
-3.4 | — |
| SECONDARY Change From Baseline in Health Status of EuroQol 5 Dimension (EQ-5D) at 52 Weeks |
0.1 | — |
| SECONDARY Change From Baseline in Fibromyalgia Activity Score (FAS-31) at 52 Weeks |
-5.2 | — |
| SECONDARY Change From Baseline in the Japanese Version of the Revised Fibromyalgia Impact Questionnaire (JFIQR) at 52 Weeks |
-15.2 | — |
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of Fibromyalgia
- Pregabalin naive patient
Exclusion Criteria
- Clinical diagnosis of neuropathic pain
Data sourced from ClinicalTrials.gov (NCT01773993). 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.