Post-operative pain after a dental surgical procedure (third molar surgery). MedDRA version: 9.1 Level: LLT Classification code 10054711 Term: Postoperative pain
Conditions
Interventions
Trade Name: Azur compositum
Pharmaceutical Form: Tablet
INN or Proposed INN: Paracetamol
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 350-
INN or Proposed INN: C
Sponsors
Steiner & Co. Deutsche Arzneimittelgesellschaft mbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the trial is to investigate the analgesic efficacy and safety of a paracetamol/codeine/caffeine fixed-dose combination (Azur® compositum) compared to paracetamol/codeine (Azur® compositum SC). ;Secondary Objective: none;Primary end point(s): The primary endpoint is the mean change from baseline pain intensity scores 1 hour after onset of pain and intake of trial medication assessed by the patient on a 100 mm Visual Analogue Scale. | — |
Countries
Germany
Outcome results
None listed