EUCTR2010-021604-16-DEActive, not recruitingNot Applicable
A double-blind, randomized, placebo controlled study to evaluate the effectiveness of etoricoxib as an additive analgesic to epidural analgesia in colon or rectum fast-track surgery - Etoricoxib fast-track
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •- age >= 18 years
- •- written informed consent
- •- no inclusion in other medical studies according to the AMG (German drug law) during the study period
- •- realization of planned colon or rectum surgery in the fast track design after clinical standards including an epidural catheter
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 70
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
Exclusion Criteria
- •- ASA status IV-V
- •- allergy against etoricoxib, other components or other NSAID
- •- coronary heart disease
- •- heart insufficiency NYHA II-IV
- •- cerebrovascular disease
- •- peripheral arterial occlusive disease
- •- untreated arterial hypertonus
- •- active peptic ulcera or active gastrointestinal bleeding
- •- light to severe liver dysfunction (beginning from Child - Plugh - Classification A)
- •- kidney insufficiency
- •- inflammatory bowl disease
- •- pregnancy or lactation
- •- placement in an institution on order of an official authority
- •- missing consent for saving and passing on pseudonymous data
- •- hereditary galactose-intolerance, lactase deficit, glucose-galactose-malabsorption
- •- no correct epidural catheter placement within 48 h after surgery
Investigators
Similar Trials
Active, not recruiting
Phase 1
Study of efficacy and safety of canakinumab in patients with Hereditary Periodic FeversHereditary Periodic Fevers (TRAPS, HIDS, or crFMF)MedDRA version: 18.0Level: PTClassification code 10016207Term: Familial mediterranean feverSystem Organ Class: 10010331 - Congenital, familial and genetic disordersMedDRA version: 18.0Level: LLTClassification code 10067783Term: Tumor necrosis factor receptor-associated periodic syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disordersMedDRA version: 18.0Level: PTClassification code 10072010Term: Hyper IgD syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2013-004291-35-HUovartis Pharma Services AG180
Completed
Phase 2
A randomized, double-blind, placebo controlled study to assess the pharmacodynamics, safety/tolerability and efficacy of omiganan in patients with mild to moderate atopic dermatitiseczema10014982atopic dermatitisNL-OMON42598Cutanea Life Sciences36
Active, not recruiting
Not Applicable
A randomized, double-blind, placebo controlled study to assess efficacy, safety and tolerability of LCQ908 in subjects with Familial Chylomicronemia SyndromeEUCTR2011-005535-68-NLovartis Pharma Services AG42
Active, not recruiting
Phase 1
Study of efficacy and safety of canakinumab in patients with Hereditary Periodic FeversEUCTR2013-004291-35-BEovartis Pharma Services AG180
Completed
Phase 3
A randomized, double-blind, placebo controlled study to assess efficacy, safety and tolerability of LCQ908 in subjects with Familial Chylomicronemia SyndromeFamilial Chylomicronemia Syndrome10013317NL-OMON39328ovartis4