Status:
TERMINATED
Etoricoxibe - Preemptive and Postoperative Analgesia for Abdominal and Thoracic Surgery
Lead Sponsor:
Ludwig-Maximilians - University of Munich
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Pain
Abdominal Surgery
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This randomised placebo controlled double-blinded bicentre study (phase III) was designed to evaluate the preemptive and postoperative analgetic impact of etoricoxibe in open abdominal and thoracic su...
Detailed Description
Etoricoxib (brand name Arcoxia worldwide; also Algix and Tauxib in Italy) is a new COX-2 selective inhibitor (approx. 106.0 times more selective for COX-2 inhibition over COX-1). Doses are 120 mg/day ...
Eligibility Criteria
Inclusion
- Programmed abdominal or thoracic surgery
- Patients \> 18 yrs
- Patients are aware of German language
- Participation is voluntary
- ASA-risk class 1-2 (American Society of Anesthesiologists guidelines)
Exclusion
- Severe cardiac, pulmonary, renal or neurologic disease
- ASA risk III and IV
- Insulin dependent Diabetes mellitus
- Polyneuropathy
- Chronic pain
- Use of analgesic drugs
- Ulcus duodeni
- Ulcus ventriculi
- Time after intestinal bleeding
- Allergy reactions towards coxibes or coxibe-like drugs
- Pregnancy and lactation
- Severe hepatic disease (Albumin \< 25 g/l or Child-Pugh-Score ≥ 10)
- Children and Teenager \< 16 years
- Chronic intestinal inflammation
- Heart failure (NYHA II - IV)
- Inbalancend arterial hypertension
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT00716833
Start Date
February 1 2006
End Date
December 1 2011
Last Update
January 16 2015
Active Locations (2)
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1
Zentrum für Pneumologie und Thoraxchirurgie, Asklepios Fachkliniken München-Gauting
Gauting, Germany, 82131
2
Chirurgische Klinik und Poliklinik, Innenstadt, Klinikum der Universität München
München, Germany, 80336