tandpijn dental pain
Conditions
Interventions
None listed
Sponsors
Kendle International
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To implement the Post Surgical Dental Pain Model at the Kendle Clinical Pharmacology Unit in cooperation with Departments of Oral and Maxillofacial Surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| To show the ability to discriminate between the analgesic effect of a single oral dose of Ibuprofen 400 mg and a single oral dose of placebo in patients with moderate to severe pain following 3rd molar extraction. | — |
Countries
Netherlands
Outcome results
None listed