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Study to Evaluate the Efficacy of Pre-operative Administration of Etoricoxib 120 mg, Etoricoxib 120 mg and Paracetamol 1 g Combination or Placebo in the Treatment of Postoperative Pain in Patients Undergoing Gynaecologic Laparoscopic Surgery

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ClinicalTrials.gov Identifier: NCT00763685
Recruitment Status : Terminated (The gynecological laparoscopic surgery transition to day surgery made following the study protocol not possible.)
First Posted : October 1, 2008
Last Update Posted : January 31, 2012
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Tiina Arumagi, East Tallinn Central Hospital

Tracking Information
First Submitted Date  ICMJE September 30, 2008
First Posted Date  ICMJE October 1, 2008
Last Update Posted Date January 31, 2012
Study Start Date  ICMJE June 2010
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 30, 2008)
Pain scale [ Time Frame: 24 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2008)
Vomiting [ Time Frame: 24 hours ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Efficacy of Pre-operative Administration of Etoricoxib 120 mg, Etoricoxib 120 mg and Paracetamol 1 g Combination or Placebo in the Treatment of Postoperative Pain in Patients Undergoing Gynaecologic Laparoscopic Surgery
Official Title  ICMJE Double-Blind, Randomized, Placebo -Controlled Study to Evaluate the Efficacy of Pre-operative Administration of Etoricoxib 120 mg, Etoricoxib 120 mg and Paracetamol 1 g Combination or Placebo in the Treatment of Postoperative Pain in Patients Undergoing Gynaecologic Laparoscopic Surgery
Brief Summary

Primary Hypothesis:

1. The analgesic effect of etoricoxib 120 mg administered 1 hour preoperatively is greater than that of placebo in the treatment of postoperative pain.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Pain
Intervention  ICMJE Drug: etoricoxib
etoricoxib 120 mg, paracetamol 1 g
Study Arms  ICMJE
  • Active Comparator: etoricoxib 120 mg
    active control
    Intervention: Drug: etoricoxib
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: etoricoxib
  • Active Comparator: 3
    Paracetamol 1 g and etoricoxib 120 mg
    Intervention: Drug: etoricoxib
Publications * Not Provided

*   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 Terminated
Actual Enrollment  ICMJE
 (submitted: January 29, 2012)
40
Original Estimated Enrollment  ICMJE
 (submitted: September 30, 2008)
180
Actual Study Completion Date  ICMJE November 2011
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Type of gynaecologic surgery:

    • diagnostic laparoscopy
    • sterilization
    • removal of ovarial cyst
    • chromopertubation
    • laparoscopic myomectomy
    • laparoscopic fenestration of ovaria
    • laparoscopic adhesiolysis
  2. Age 18-50 years.
  3. Evaluated risk of anaesthetic procedure according to ASA (American Society of Anaesthesiologist) classification: ASA I or II.
  4. Patients agreed to participate in the study and signed the informed consent.

Exclusion Criteria:

  1. ASA III or more
  2. Emergency surgery
  3. Major laparoscopic surgery i.e. hysterectomy
  4. Duration of surgery more than 90 minutes
  5. Chronic pain
  6. History of hypersensitivity to the active substance or to any of the excipients of study drug (Paracetamol or Etoricoxib)
  7. Active peptic ulceration or active gastro-intestinal (GI) bleeding.
  8. Patients who have experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria, or allergic-type reactions after taking acetylsalicylic acid or NSAIDs including COX-2 (cyclooxygenase-2) inhibitors.
  9. Pregnancy and lactation
  10. Severe hepatic dysfunction (serum albumin < 25 g/l or Child-Pugh score ≥ 10).
  11. Estimated renal creatinine clearance < 30 mL/min.
  12. Children and adolescents under 16 years of age.
  13. Inflammatory bowel disease.
  14. Congestive heart failure (NYHA II-IV).
  15. Patients with hypertension whose blood pressure has not been adequately controlled.
  16. Established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease, unstable angina.
  17. Patient has undergone coronary artery bypass graft surgery, angioplasty, or had myocardial infarction, cerebrovascular accident or transient ischemic attack within the past 6 months.
  18. History of drug abuse.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Estonia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00763685
Other Study ID Numbers  ICMJE 35195
EUDRACT 2008-004098-17
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tiina Arumagi, East Tallinn Central Hospital
Study Sponsor  ICMJE East Tallinn Central Hospital
Collaborators  ICMJE Merck Sharp & Dohme Corp.
Investigators  ICMJE
Principal Investigator: Tiina Arumägi, MD East Tallinn Central Hospital
PRS Account East Tallinn Central Hospital
Verification Date January 2012

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