Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-24 @ 11:49 PM
NCT ID:
NCT02183051
Eligibility Criteria:
Inclusion Criteria:
* Male or female aged 18 years or above
* Patients undergoing removal of one impacted mandibular third molar under local anesthesia. (Short duration anaesthetics will be allowed, i.e. mepivacaine 3% in Italy and Spain and xylocaine in USA, both without vasoconstrictors) Only patients with type of inclusion II to IV have to be included (type II, molar in the submucosa; type III, molar partially included in the bone; type IV, molar fully included in the bone)
* Assessment of pain must be at least 50 mm on a 100 mm visual analogue scale (VAS)
* Patient informed consent in accordance with local legislation.
Exclusion Criteria:
* Type I of inclusion (molar partially or totally erupted)
* Known or suspected hypersensitivity to trial drug or their excipients, analgesics, antipyretics or nonsteroidal antiinflammatory drug (NSAIDs)
* Any clinical evidence of active peptic ulceration during the last six month
* Recurrent ulcers
* Pregnancy or breast feeding
* Asthma, nasal polyps, angioneurotic oedema or urticaria following the administration of aspirin or NSAIDs
* Concomitant treatment with anti-coagulants (including heparin), lithium
* Concomitant administration of other anti inflammatory or analgesic agents
* Administration of any drug with analgesic properties in the 24 h previous to the administration of the study drug, except the local anesthetic for the surgery
* Administration of any antibiotics
* Significant perioperative complication judged by the oral surgeon
* Clinical evidence of or known severe cardiac, hepatic, renal, metabolic, hematological disease (including bleeding disorders), mental disturbance, ulcerative colitis
* Any other disease that could interfere with the evaluation of efficacy and safety
* Participation in another clinical trial during this study or during the previous month
* Previous participation in this trial
* Patient unable to comply with the protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02183051
Study Brief:
Protocol Section:
NCT02183051