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A Multiple Dose, Randomized, Double-Blind Multicenter Study Of The Efficacy And Safety Of Pregabalin Compared To Placebo In The Treatment Of Patients With Post-Surgical Pain From Hysterectomy
To assess the efficacy of pregabalin compared to placebo on pain following hysterectomy , measured using subject reported assessments of pain.
Details
| Lead sponsor | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 501 |
| Start date | 2007-06 |
| Completion | 2010-10 |
Conditions
- Pain, Postoperative
Interventions
- pregabalin (Lyrica)
- pregabalin (Lyrica)
- matched placebo
Primary outcomes
- Worst Pain Using the Modified Brief Pain Inventory - Short Form (m-BPI-sf) — Day 2 (24 hours post surgery [PS])
Modified Brief Pain Inventory - Short Form (m-BPI-sf): participant rated 11-point Likert rating scale ranged from 0 (no pain) to 10 (worst pain imaginable). Least Square (LS) Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.
Countries
United States, Canada, Czechia, Hong Kong, South Africa, Spain, Sweden, Thailand, United Kingdom