A controlled, randomized, double-blind, cross-over study of the onset of analgesic effect of two formulations of ibuprofen for the treatment of pain after oral surgery.

• Conditions: Pain; MedDRA version: 12.0Level: LLTClassification code 10033371Term: Pain

• Registration Number: EUCTR2009-015589-74-SE
• Lead Sponsor: ycomed Sweden Holding 2 AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-04
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 140

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.