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

INTERVENTION: 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: Codeinphosphat‐Hemihydrat Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 30‐ INN or Proposed INN: Coffein Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50‐ Trade Name: Azur compositum SC Pharmaceutical Form: Tablet INN or Proposed INN: Paracetamol Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500‐ INN or Proposed INN: Codeinphosphat‐Hemihydrat Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 30‐ CONDITION: Post‐operative pain after a dental surgical procedure (third molar surgery). ; MedDRA version: 9.1 Level: LLT Classification code 10054711 Term: Postoperative pain PRIMARY OUTCOME: 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).; ; ; 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.; ; Secondary Objective: none 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