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 @ 12:13 PM
Ignite Modification Date:
2025-12-24 @ 12:13 PM
NCT ID:
NCT01266161
Eligibility Criteria:
Inclusion Criteria:
* Males and females 16 to 40 years of age
* Subjects who undergo surgical removal of at least two third molars
* One of which must be a partial or full bony mandibular impaction
* Subjects must have at least moderate baseline pain (a score of 2 on the categorical pain severity rating scale) confirmed by a score of at least 50 mm on the 100-mm visual analog scale-pain severity rating scale (VAS-PSR)
Exclusion Criteria:
* Acute localized dental infection at the time of surgery that could confound the post-surgical evaluation
* Presence or history of any significant organ disease
* Use of prescription or OTC first generation antihistamines
* Females who are pregnant, lactating or of childbearing potential and not using a medically approved method to prevent pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
40 Years
Study:
NCT01266161
Study Brief:
Protocol Section:
NCT01266161