Randomised, double-blind, prospective multi-centre study to compare the analgesic efficacy and safety of a paracetamol/codeine/caffeine fixed-dose combination (Azur® compositum) with paracetamol/codeine (Azur® compositum SC) in patients with moderate pain after third molar dental surgery - Azurcomp-Molar
- Conditions
- Post-operative pain after a dental surgical procedure (third molar surgery).MedDRA version: 9.1Level: LLTClassification code 10054711Term: Postoperative pain
- Registration Number
- EUCTR2007-002784-27-DE
- Lead Sponsor
- Steiner & Co. Deutsche Arzneimittelgesellschaft mbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
The patients will only be included in the trial if they meet all of the following criteria:
•Male and female outpatients aged 18 years and above
•X-ray confirmed diagnosis of impacted third molar
•Ability to swallow tablets
•Willingness to abstain from caffeinated drinks and food on the day of the surgery
•Sufficient knowledge of German language to understand trial instructions and rating scales
•Written informed consent prior to enrolment
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
The patients will only be included in the trial if they do not meet any of the following criteria:
•Adolescents < 18 years
•Hypersensitivity to paracetamol, caffeine, codeine or any other ingredients of the investigational medicinal product
•Severe hepatocellular insufficiency
•Severe respiratory insufficiency
•Pneumonia
•Acute exacerbation of asthma
•Pregnancy or breast feeding
•Necessity of general anaesthesia
•Known alcohol, narcotics, or drug abuse
•No consent to recording and processing of pseudonymised data according to legal requirements
•Participation in another clinical trial within the last 30 days
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method