Study Of The Efficacy And Safety Of Pregabalin Compared To Placebo For Treatment Of Post-Surgical Pain From Hysterectomy

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

To assess the efficacy of pregabalin compared to placebo on pain following hysterectomy , measured using subject reported assessments of pain.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer; Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Treatments: Pregabalin

Criteria

Inclusion Criteria:

• The subject will have elective total abdominal hysterectomy using a transverse incision with or without bilateral salpingo-oophorectomy. The total hysterectomy may, however, be cervix-sparing.

• The subject is expected to remain at the hospital (or intermediate care facility) for a minimum of 2 days following surgery.

• The subject's preoperative health is graded as the American Society of Anesthesiologist P1 to P2.

Exclusion Criteria:

• Subjects having vaginal hysterectomy (whether laparoscopically assisted or not)

• Subjects having additional procedures (such as those involving the bladder) at the same time as the total abdominal hysterectomy

• The use of nerve block, spinal anesthesia or epidural anesthesia for post-surgical pain control

• Subjects who have been using any opioid medications 2 weeks or more continuously within 3 months prior to the screening visit.

• The subject has taken any NSAID or any analgesic other than acetaminophen within 3 days prior to surgery or is unwilling to abstain from NSAIDs or other analgesics, except as specified in the protocol, during the study. (Subjects taking <325 mg per day of aspirin at a stable dose for at least 30 days before the first dose of study medication will be allowed to continue their aspirin regimen for the duration of the study).