Status:
UNKNOWN
Etoricoxib in Ear Nose Throat Surgery
Lead Sponsor:
University of Regensburg
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Tonsillectomy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The aim of this study is to test the analgesic efficacy of etoricoxib (90 mg or 120 mg qd. perioperatively) for post-operative pain relief. The primary endpoint is as follows: * does preoperative et...
Detailed Description
On day of surgery (day 0) the patients will be randomly assigned to one of the three groups using a sealed envelope method. The etoricoxib 90 mg group receives etoricoxib (Arcoxia®, Merck Sharp \& Doh...
Eligibility Criteria
Inclusion
- male or female patients
- 18 years of age
- female patients not pregnant/non-lactating
- indication for elective tonsillectomy
- written informed consent.
Exclusion
- etoricoxib, other analgesic or anti-emetic medication within 10 half-lives
- evidence for active peptic ulceration
- history of gastrointestinal bleeding
- evidence of hepatic, renal or hematopoietic disorders
- heart failure (NYHA II-IV)
- uncontrolled arterial hypertension
- clinical evidence of arterial occlusive disease
- coronary heart disease or cerebrovascular disease
- inflammatory bowel disease
- hypersensitivity to analgetics, antipyretics, NSAIDs or antiemetics
- evidence for noncompliance
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00756873
Start Date
October 1 2008
End Date
December 1 2009
Last Update
September 22 2008
Active Locations (2)
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1
Universtiy Hospital Regensburg
Regensburg, Germany, 93053
2
Weiden Clinic
Weiden I.d. OPf., Germany, 92637