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:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-25 @ 4:25 AM
NCT ID:
NCT01307020
Eligibility Criteria:
Inclusion Criteria:
Patients meeting ALL the following criteria will be eligible for entry into the study:
* Male or female patients aged 18 to 70 years old. Females participating in the study must be either: of non-childbearing potential, or willing to use a highly effective contraceptive method.
* Scheduled for outpatient surgical extraction -under local anaesthesia- of third mandibular molar teeth, with at least one of which is fully or partially impacted in the mandible requiring bone manipulation.
* Normal physical examination or without clinically relevant abnormalities.
At randomisation (after surgery):
No intake of analgesics (including prescription and over the counter drugs) within 24h prior to the surgery.
* No complication during the surgery, duration of surgery \< 1 hour and not requiring re-anaesthesia.
* Patients experiencing pain of moderate or higher intensity in the first four hours after the end of surgery.
Exclusion Criteria:
* History of allergy or hypersensitivity to NSAIDs, opioids or acetyl salicylic acid.
* History of asthma, bronchospasm, acute rhinitis, nasal polyps, urticaria or angioneurotic oedema.
* History of peptic ulcer, gastrointestinal disorders by NSAIDs, gastrointestinal bleeding or other active bleedings.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01307020
Study Brief:
Protocol Section:
NCT01307020