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

Condition(s) targeted: Postoperative Pain

Intervention: pregabalin (Lyrica) (Drug); pregabalin (Lyrica) (Drug); matched placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

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

Official title: 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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Primary outcome: The primary endpoint is the pain reported by subjects, using the Worst pain Numerical Rating Scale on first day after the surgery.

Secondary outcome:

Quality of life using EuroQol (EQ-5D) Health State Profile.

The percentage of baseline peak expiratory flow (PEF) measured at each post-operative assessment time.

Post-discharge average and worst pain severity measured in daily subject diaries (NRS - Average Pain, NRS - Worst Pain).

A total CME score calculated by summing the number of Clinically Meaningful Events (CMEs) across symptoms. CME for each symptom will be defined using the Opioid-Related Symptom Distress Scale (OR-SDS).

The amounts of opioids used following surgery. The total cumulative dose will be calculated as mg of morphine equivalent and will include opioids administered by any route (PCA pump, parenteral bolus, or oral). It will be evaluated at 24 hours, 48

hours, time of discharge from the hospital, and time of the Begin Taper visit.

Sleep interference post surgery measured in daily subject diaries (NRS Sleep).

All serious adverse events (SAEs), all treatment-emergent adverse events (AEs).

Incidence of chronic post-operative pain at 3 and 6 months following surgery and the characteristics of the pain in those subjects reporting it (mBPI-sf, NPSI).

Subject satisfaction with pain treatment using the Pain Treatment Satisfaction Scale (PTSS).

Prespecified adverse events of wound healing complications.

Interference of pain with aspects of daily activities measured using the Modified Brief Pain Inventory Short Form (mBPI-sf).

Subject satisfaction with study medication with the Global Evaluation of Study Medication.

The integrated analgesic score (a combination of opioid use and resting pain as defined by Silverman et al 1993).

Vital signs and clinical laboratory parameters (Refer to Appendix 6).

Time from the end of surgery, in hours, to meet protocol-defined hospital discharge criteria as well as the time to actual hospital discharge.

The amounts of non-opioid rescue medications used by the subjects during the study, including anti-emetic medications.

There are separate secondary endpoints for pain with movement caused by sitting and for pain with movement caused by the peak expiratory flow (PEF) test.

Anxiety (VAS) before and after the surgery.

The pain reported by the subjects with movement (NRS Current Pain) at each assessment time during the hospital stay and the area under the curve (AUC) of pain reported by the subjects with movement during the hospital stay.

Measurement of Incision lenght will be used as an exploratory endpoint to correlate with worst pain.

Functional mobility after surgery as measured by the timed up and go (TUG) test.

The pain reported by the subjects at rest (NRS Current Pain) at each assessment time during the hospital stay and the area under the curve (AUC) of pain reported by the subjects at rest during the hospital stay.

Minimum age: 25 Years. Maximum age: 70 Years. Gender(s): Female.

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).

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, Shatin, Hong Kong; Recruiting

Pfizer Investigational Site, Kowloon, Hong Kong; Recruiting

Pfizer Investigational Site, CADIZ 11009, Spain; Recruiting

Pfizer Investigational Site, MADRID 28046, Spain; Recruiting

Pfizer Investigational Site, VALENCIA 46010, Spain; Recruiting

Pfizer Investigational Site, Stockholm 182 88, Sweden; Recruiting

Pfizer Investigational Site, Lund 221 85, Sweden; Recruiting

Pfizer Investigational Site, Orebro 701 85, Sweden; Recruiting

Pfizer Investigational Site, Liverpool L8 7SS, United Kingdom; Recruiting

Pfizer Investigational Site, Livingstone EH54 6PP, United Kingdom; Recruiting

Pfizer Investigational Site, Birmingham, United Kingdom; Recruiting

Pfizer Investigational Site, Mobile, Alabama 36608, United States; Recruiting

Pfizer Investigational Site, Bangkoknoi, Bangkok 10700, Thailand; Recruiting

Pfizer Investigational Site, Muang, Chiang Mai 50200, Thailand; Recruiting

Pfizer Investigational Site, Johannesburg, Gauteng 1829, South Africa; Recruiting

Pfizer Investigational Site, Pretoria, Gauteng 0002, South Africa; Not yet recruiting

Pfizer Investigational Site, Ladysmith, KZN 3370, South Africa; Recruiting

Pfizer Investigational Site, Muang, Khon Kaen 40002, Thailand; Recruiting

Pfizer Investigational Site, Toronto, Ontario M5G 1X5, Canada; Not yet recruiting

Pfizer Investigational Site, Philadelphia, Pennsylvania 19104, United States; Recruiting

Pfizer Investigational Site, Pittsburgh, Pennsylvania 15232, United States; Recruiting

Pfizer Investigational Site, Pittsburgh, Pennsylvania 15213, United States; Recruiting

Pfizer Investigational Site, Montreal, Quebec H2X 1P1, Canada; Recruiting

Pfizer Investigational Site, Sherbrooke, Quebec J1H 5N4, Canada; Recruiting

Pfizer Investigational Site, Edinburgh, Scotland EH16 4SA, United Kingdom; Recruiting

Pfizer Investigational Site, Houston, Texas 77024, United States; Not yet recruiting

Pfizer Investigational Site, Cape Town, Western Cape 7500, South Africa; Recruiting

To obtain contact information for a study center near you, click here.

Starting date: May 2007
Ending date: January 2009
Last updated: October 30, 2008