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

Last updated on December 16, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Mobile, Alabama, 36608 United States
Contact
1-800-718-1021
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 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).

NCT00468845
Pfizer
Completed
Study Of The Efficacy And Safety Of Pregabalin Compared To Placebo For Treatment Of Post-Surgical Pain From Hysterectomy

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Study Of The Efficacy And Safety Of Pregabalin Compared To Placebo For Treatment Of Post-Surgical Pain From Hysterectomy
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
To assess the efficacy of pregabalin compared to placebo on pain following hysterectomy , measured using subject reported assessments of pain.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Pain, Postoperative
  • 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
  • Experimental: 1
    Intervention: Drug: pregabalin (Lyrica)
  • Experimental: 2
    Intervention: Drug: pregabalin (Lyrica)
  • Placebo Comparator: 3
    Intervention: Drug: matched placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
501
October 2010
May 2010   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: Female
25 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Czech Republic,   Hong Kong,   South Africa,   Spain,   Sweden,   Thailand,   United Kingdom,   United States
 
 
NCT00468845
A0081153
Yes
Not Provided
Not Provided
Director, Clinical Trials Disclosure Group, Pfizer, Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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