A, randomised, double-Blind, placebo-controlled pilot study with ibuprofen to implement the Post Surgical Dental Pain Model at the Kendle Clinical Pharmacology Unit in cooperation with Departments of Oral and Maxillofacial Surgery

1. Subjects must be male or female and at least 18 years of age;
2. Females should not be pregnant;
3. Subjects must voluntarily sign a written informed consent agreement approved by the Independent Ethics Committee (IEC) after explanation of the nature and objectives of the study and prior to any study specific procedure;
4. Subject has had surgical extraction from up to four 3rd molars of which at least one is a fully or partially impacted mandibular 3rd molar;
5. Subject has a baseline measurement of at least moderate pain on a 4 point Likert scale (*none*, *slight*, *moderate*, *severe pain*) and a minimum of 50 mm on a 100 mm VAS Pain Intensity Scale (*no pain* - *very severe pain*);
6. The subject receives the study medication within 4 hours after completion of surgery;
7. Subjects must otherwise be in good health, based upon the results of medical history;
8. Subject is awake and alert and able to complete protocol-specified assessments.

1. Female subjects that are pregnant (as shown by a positive urine pregnancy test) or lactating;
2. Subject should not have other (c honic) pain than pain caused by the molar extraction;
3. Subjects with contraindication for Ibuprofen like asthma, gastrointestinal bleeding, use of anticoagulants, bleeding disorders;
4. Subjects with contraindication for dental surgery;
5. Smoking is not allowed from pre-treatment until discharge;
6. Treatment with short-acting analgesics (paracetamol, aspirin) within 6 hours prior to surgery, ibuprofen within 10 hours prior to surgery and/or long-acting NSAIDs (naproxen, etc) or COX-2 inhibitors within 48 hours prior to surgery. Except for preoperative en intraoperative anaesthetic, treatment with drugs that can confound the analgesic response (like tricyclic antidepressants, sedatives, tranquilizers, antihistamines) within 5 half lifes of the respective drug prior to surgery;
7. Subjects who receive surgical medication other than lignocain 2% (with epinep hine 1:100,000?); to be discussed
8. Subjects with a presence or a history of clinically relevant conditions in the gastrointestinal, hepatic, renal, urogenital, cardiovascular, metabolic, endocrine or central and peripheral nervous systems;
9. Subjects with active presence or history of alcoholism or drug addiction;
10. Subjects with positive alcohol and drugs screen;
11. Subjects with a relevant food or drug hypersensitivity or allergy;
12. Subject with intolerance to any ingredients of the placebo;
13. Subjects who are considered unsuitable to participate in the study for any reason in the opinion of the principal investigator;