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

Completed · Phase 3 · Has a placebo group

Conditions studied: Pain, Postoperative

In brief

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

Key facts

Study ID

NCT00468845

Run by

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

People needed

501

Starts

2007-06-01

Expected to finish

2010-10-01

Last updated by the study team

2021-02-10

Who can join

Age: 25 and older, up to 70. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Pfizer Investigational Site — Mobile, Alabama, United States
• Pfizer Investigational Site — Glendale, Arizona, United States
• Pfizer Investigational Site — Phoenix, Arizona, United States
• Pfizer Investigational Site — Phoenix, Arizona, United States
• Pfizer Investigational Site — Phoenix, Arizona, United States
• Pfizer Investigational Site — Glendale, California, United States
• Pfizer Investigational Site — Pasadena, California, United States
• Pfizer Investigational Site — Miami, Florida, United States
• Pfizer Investigational Site — Miami, Florida, United States
• Pfizer Investigational Site — Philadelphia, Pennsylvania, United States
• Pfizer Investigational Site — Pittsburgh, Pennsylvania, United States
• Pfizer Investigational Site — Pittsburgh, Pennsylvania, United States
• Pfizer Investigational Site — Houston, Texas, United States
• Pfizer Investigational Site — Houston, Texas, United States
• Pfizer Investigational Site — Calgary, Alberta, Canada
• Pfizer Investigational Site — Montreal, Quebec, Canada
• Pfizer Investigational Site — Sherbrooke, Quebec, Canada
• Pfizer Investigational Site — Prague, Czechia
• Pfizer Investigational Site — Kowloon, Hong Kong
• Pfizer Investigational Site — Shatin, Hong Kong
• Pfizer Investigational Site — Johannesburg, Gauteng, South Africa
• Pfizer Investigational Site — Krugersdorp, Gauteng, South Africa
• Pfizer Investigational Site — Pretoria, Gauteng, South Africa
• Pfizer Investigational Site — Ladysmith, KwaZulu-Natal, South Africa
• Pfizer Investigational Site — Newcastle, KwaZulu-Natal, South Africa

Full record on ClinicalTrials.gov

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