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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

501 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2010-10-31

Brief Summary

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

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Detailed Description

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Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

pregabalin (Lyrica)

Intervention Type DRUG

150 mg/day double blind (divided doses)

2

Group Type EXPERIMENTAL

pregabalin (Lyrica)

Intervention Type DRUG

300 mg/day double blind (divided doses)

3

Group Type PLACEBO_COMPARATOR

matched placebo

Intervention Type DRUG

matched placebo

Interventions

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pregabalin (Lyrica)

150 mg/day double blind (divided doses)

Intervention Type DRUG

pregabalin (Lyrica)

300 mg/day double blind (divided doses)

Intervention Type DRUG

matched placebo

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No