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

NCT00468845

Last updated date
Study Location
Pfizer Investigational Site
Mobile, Alabama, 36608, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Postoperative Pain
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
25-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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).

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Of The Efficacy And Safety Of Pregabalin Compared To Placebo For Treatment Of Post-Surgical Pain From Hysterectomy
Official Title  ICMJE 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
Brief Summary To assess the efficacy of pregabalin compared to placebo on pain following hysterectomy , measured using subject reported assessments of pain.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pain, Postoperative
Intervention  ICMJE
  • Drug: pregabalin (Lyrica)
    150 mg/day double blind (divided doses)
  • Drug: pregabalin (Lyrica)
    300 mg/day double blind (divided doses)
  • Drug: matched placebo
    matched placebo
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: pregabalin (Lyrica)
  • Experimental: 2
    Intervention: Drug: pregabalin (Lyrica)
  • Placebo Comparator: 3
    Intervention: Drug: matched placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 12, 2010)
501
Original Enrollment  ICMJE
 (submitted: May 1, 2007)
300
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 25 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Czechia,   Hong Kong,   South Africa,   Spain,   Sweden,   Thailand,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT00468845
Other Study ID Numbers  ICMJE A0081153
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
Study Sponsor  ICMJE Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP