Status:
COMPLETED
Study Of The Efficacy And Safety Of Pregabalin Compared To Placebo For Treatment Of Post-Surgical Pain From Hysterectomy
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Pain, Postoperative
Eligibility:
FEMALE
25-70 years
Phase:
PHASE3
Brief Summary
To assess the efficacy of pregabalin compared to placebo on pain following hysterectomy , measured using subject reported assessments of pain.
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
501 Patients enrolled
Trial Details
Trial ID
NCT00468845
Start Date
June 1 2007
End Date
October 1 2010
Last Update
February 10 2021
Active Locations (42)
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1
Pfizer Investigational Site
Mobile, Alabama, United States, 36608
2
Pfizer Investigational Site
Glendale, Arizona, United States, 85308
3
Pfizer Investigational Site
Phoenix, Arizona, United States, 85020
4
Pfizer Investigational Site
Phoenix, Arizona, United States, 85023