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 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT01512160
Eligibility Criteria:
Inclusion Criteria:
* Oral surgical procedure having removed 2 third molars (unilateral).
* Pre-dose pain intensity score (100 mm Visual Analog Scale \[VAS\]) \>50 mm within 5 hours of oral surgery.
* Pre-dose pain intensity score of moderate or within 5 hours of oral surgery.
Exclusion Criteria:
* Presence or history of any significant hepatic, renal, endocrine, cardiovascular, neurological (including subjects with a history of frequent moderate to severe headaches or subjects with episodic migraines more than twice per month), psychiatric, gastrointestinal, pulmonary, hematologic, or metabolic disorder.
* Prior use of any type of analgesic or NSAID within five half-lives of that drug or less before taking the first dose of study medication, except for anesthesia for the procedure.
* Recent history of chronic analgesic or tranquilizer dependency.
* Active dental infection at the time of surgery.
* Any significant oral surgery complication at the time of surgery or in the immediate postoperative period or dental surgery lasting \> 30 minutes.
* Subjects who are smokers.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01512160
Study Brief:
Protocol Section:
NCT01512160