Pain MedDRA version: 12.0 Level: LLT Classification code 10033371 Term: Pain
Conditions
Interventions
Product Name: Ibuprofen Rapid
Product Code: NA
Pharmaceutical Form: Film-coated tablet
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product
Sponsors
Nycomed Sweden Holding 2 AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Indication for surgical removal of two impacted or partly impacted mandibular third molars 2) Written informed consent after verbal and written information. 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A.Exclusion criteria related to Ibuprofen 1) An active gastric or duodenal ulcer 2) Hypersensivity to NSAIDs or ASA 3) Severe liver or kidney disorder 4) Bleeding disorder 5) Treatment with anticoagulantia B. General exclusion criteria 1) Pregnancy, actual or intended 2) Systemic diseases which could endanger the participating patients 3) Patients who were assumed not to be able to carry out the study for instance patients who were not speaking or writing local language 4) Patients who are regarded to have high risk for alveolitis (dry socket pain) e.g. heavy smokers and diabetic patients 5) Intake of analgesics including NSAIDs for 12 hours before tooth removal of surgery 6) Lack of ability or willingness to comply with the protocol 7) Alcohol intake on the day of surgery. 8) Drug abusers 9) Other circumstances observed during the surgery, at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary aim of the study is to compare the time to onset of substantial analgesic effect of a new formulation of ibuprofen (the investigational product) to that of a conventional tablet (Nurofen®) in patients having removal of impacted or partly impacted third molars. ;Secondary Objective: The secondary aim is to compare the analgesic effect and the safety of the two formulations in the above mentioned patient group.;Primary end point(s): The primary endpoint is time to substantial pain relief recorded as the time of the second stop watch. If this watch is not stopped before end of the evaluation period (120 minutes), the time will be censored at 120 minutes. | — |
Countries
Denmark, Sweden
Outcome results
None listed