Etoricoxib in Ear Nose Throat Surgery
Analgesic Efficacy and Safety of Etoricoxib in Ear Nose Throat Surgery
1 other identifier
interventional
90
1 country
2
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 etoricoxib reduce the post-operative opioid utilization in patients undergoing elective tonsillectomy under general anaesthesia (i.e. the post-operative opioid-sparing effect of etoricoxib in humans). The secondary endpoints are as follows:
- does the etoricoxib medication have an impact on PONV or activities of daily
- does the etoricoxib medication influence the blood loss during surgery or the incidence of postoperative bleeding
- does the etoricoxib medication influence the operation time. In addition, adverse effects of etoricoxib will be documented.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2008
Shorter than P25 for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 19, 2008
CompletedFirst Posted
Study publicly available on registry
September 22, 2008
CompletedStudy Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedSeptember 22, 2008
September 1, 2008
11 months
September 19, 2008
September 19, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Post-operative opioid-sparing effect of etoricoxib in humans undergoing elective tonsillectomy
Day 0-3 after surgery
Secondary Outcomes (1)
Impact of etoricoxib medication on PONV or activities of daily or the incidence of postoperative bleeding
Day 0-14
Study Arms (3)
1
PLACEBO COMPARATOR2
EXPERIMENTALEtoricoxib 90 mg qd.
3
EXPERIMENTALEtoricoxib 120 mg qd. (day 0-7) Etoricoxib 90 mg qd. (day 8-14)
Interventions
Eligibility Criteria
You may qualify if:
- male or female patients
- years of age
- female patients not pregnant/non-lactating
- indication for elective tonsillectomy
- written informed consent.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Regensburglead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (2)
Universtiy Hospital Regensburg
Regensburg, 93053, Germany
Weiden Clinic
Weiden I.d. OPf., 92637, Germany
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 19, 2008
First Posted
September 22, 2008
Study Start
October 1, 2008
Primary Completion
September 1, 2009
Study Completion
December 1, 2009
Last Updated
September 22, 2008
Record last verified: 2008-09