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

NCT00468845 | Completed Phase 3 Results DMC

• 1 other identifier: A0081153
• Study Type: interventional
• Target: 501
• Locations: 9 countries
• Sites: 42

Brief Summary

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

Conditions

Pain, Postoperative

Keywords

pain after hysterectomy; amount of opioids used

Outcome Measures

Primary Outcomes (1)

• Worst Pain Using the Modified Brief Pain Inventory - Short Form (m-BPI-sf)

  Modified Brief Pain Inventory - Short Form (m-BPI-sf): participant rated 11-point Likert rating scale ranged from 0 (no pain) to 10 (worst pain imaginable). Least Square (LS) Means adjusted for treatment, pooled center and salpingo-oophorectomy strata.

  Day 2 (24 hours post surgery [PS])

Secondary Outcomes (35)

• Current Pain - Pain With Movement Caused by Sitting

  Day 1 (day of surgery), up to 7 days PS, Discharge, 2 and 4 weeks PS

• Current Pain - Pain With Movement Caused by Peak Expiratory (PEF) Test

  Day 1, up to 7 days PS, 2 and 4 weeks PS

• Area Under the Curve (AUC) Pain - Pain With Movement Caused by Sitting

  48 +/- 4 hours PS

• Area Under the Curve (AUC) Pain - Pain With Movement Caused by Peak Expiratory Flow (PEF) Test

  48 +/- 4 hours PS

• Current Pain at Rest

  8, 16, 24, 32, 40, 48 hours PS

Other Outcomes (7)

• Percentage of Participants With Wound Healing Complications - Discharge

  Discharge (day 3 up to day 7 PS)

• Percentage of Participants With Wound Healing Complications - Day 7 PS

  Day 7 PS

• Percentage of Participants With Wound Healing Complications - Day 14 PS

  Day 14 PS

Study Arms (3)

1

EXPERIMENTAL

Drug: pregabalin (Lyrica)

2

EXPERIMENTAL

Drug: pregabalin (Lyrica)

3

PLACEBO COMPARATOR

Drug: matched placebo

Interventions

pregabalin (Lyrica) DRUG

150 mg/day double blind (divided doses)

1

matched placebo DRUG

matched placebo

3

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

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

Study Sites (42)

Pfizer Investigational Site

Mobile, Alabama, 36608, United States

Location

Pfizer Investigational Site

Glendale, Arizona, 85308, United States

Location

Pfizer Investigational Site

Phoenix, Arizona, 85020, United States

Location

Pfizer Investigational Site

Phoenix, Arizona, 85023, United States

Location

Pfizer Investigational Site

Phoenix, Arizona, 85027, United States

Location

Pfizer Investigational Site

Glendale, California, 91206, United States

Location

Pfizer Investigational Site

Pasadena, California, 91105, United States

Location

Pfizer Investigational Site

Miami, Florida, 33136-1096, United States

Location

Pfizer Investigational Site

Miami, Florida, 33136, United States

Location

Pfizer Investigational Site

Philadelphia, Pennsylvania, 19104, United States

Location

Pfizer Investigational Site

Pittsburgh, Pennsylvania, 15213, United States

Location

Pfizer Investigational Site

Pittsburgh, Pennsylvania, 15232, United States

Location

Pfizer Investigational Site

Houston, Texas, 77024, United States

Location

Pfizer Investigational Site

Houston, Texas, 77054, United States

Location

Pfizer Investigational Site

Calgary, Alberta, T2N 2T9, Canada

Location

Pfizer Investigational Site

Montreal, Quebec, H2X 3J4, Canada

Location

Pfizer Investigational Site

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Pfizer Investigational Site

Prague, 150 06, Czechia

Location

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Kowloon, 0, Hong Kong

Location

Pfizer Investigational Site

Shatin, Hong Kong

Location

Pfizer Investigational Site

Johannesburg, Gauteng, 1829, South Africa

Location

Pfizer Investigational Site

Krugersdorp, Gauteng, 1752, South Africa

Location

Pfizer Investigational Site

Pretoria, Gauteng, 0157, South Africa

Location

Pfizer Investigational Site

Ladysmith, KwaZulu-Natal, 3370, South Africa

Location

Pfizer Investigational Site

Newcastle, KwaZulu-Natal, 2940, South Africa

Location

Pfizer Investigational Site

Cape Town, Western Cape, 7500, South Africa

Location

Pfizer Investigational Site

Parktown, 2193, South Africa

Location

Pfizer Investigational Site

Cadiz, 11009, Spain

Location

Pfizer Investigational Site

Madrid, 28031, Spain

Location

Pfizer Investigational Site

Madrid, 28046, Spain

Location

Pfizer Investigational Site

Valencia, 46010, Spain

Location

Pfizer Investigational Site

Lund, 221 85, Sweden

Location

Pfizer Investigational Site

Örebro, 701 85, Sweden

Location

Pfizer Investigational Site

Stockholm, 182 88, Sweden

Location

Pfizer Investigational Site

Bangkoknoi, Bangkok, 10700, Thailand

Location

Pfizer Investigational Site

Muang, Changwat Khon Kaen, 40002, Thailand

Location

Pfizer Investigational Site

Muang, Chiang Mai, 50200, Thailand

Location

Pfizer Investigational Site

Leicester, Leicestershire, LE1 5WW, United Kingdom

Location

Pfizer Investigational Site

Edinburgh, Scotland, EH16 4SA, United Kingdom

Location

Pfizer Investigational Site

Birmingham, United Kingdom

Location

Pfizer Investigational Site

Liverpool, L8 7SS, United Kingdom

Location

Pfizer Investigational Site

Livingstone, EH54 6PP, United Kingdom

Location

Related Publications (1)

• Singla NK, Chelly JE, Lionberger DR, Gimbel J, Sanin L, Sporn J, Yang R, Cheung R, Knapp L, Parsons B. Pregabalin for the treatment of postoperative pain: results from three controlled trials using different surgical models. J Pain Res. 2014 Dec 23;8:9-20. doi: 10.2147/JPR.S67841. eCollection 2015.

  PMID: 25565885 DERIVED

Related Links

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

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2007
• First Posted: May 3, 2007
• Study Start: June 1, 2007
• Primary Completion: May 1, 2010
• Study Completion: October 1, 2010
• Last Updated: February 10, 2021
• Results First Posted: May 26, 2011

Record last verified: 2011-06

Locations

CA (3); TH (3); CZ (1); US (14); SE (3); HK (2); GB (5); ZA (7); ES (4)