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 @ 10:22 PM
Ignite Modification Date:
2025-12-24 @ 10:22 PM
NCT ID:
NCT04622735
Eligibility Criteria:
Main Inclusion Criteria:
* Male and female patient aged from 18 years up to 65 years,
* Patient scheduled to undergo the surgical removal of at least one fully or partially impacted third mandibular molar requiring bone removal under short-acting local anaesthetic (mepivacaine or lidocaine) with or without vasoconstrictor,
* Patient weighing \> 50 kg,
* Patient who has signed a written informed consent prior to any study-related procedures.
Additional inclusion criteria after surgery (randomization):
1. Patient experiencing moderate to severe pain within 4 hours after the dental extraction, defined by a baseline pain intensity Visual Analogic Scale (VAS) score ≥ 50 mm,
2. Third molar extraction(s) completed without any immediate complication, that in the opinion of the investigator, would interfere with the study conduct and/or assessments (e.g., suspected neurosensory complication, incomplete removal of tooth)
Main Exclusion Criteria:
* Patient treated by analgesics or nonsteroidal anti-inflammatory drugs (NSAIDs) within 3 days preceding the day of randomization or within 5 times the elimination half-life whichever the longest,
* Woman with positive results on a urine pregnancy test or breastfeeding woman or woman of childbearing potential without an effective contraception,
* Patient with a history of convulsive disorders,
* Patient taking mono-amine-oxidase (MAO) inhibitors (including but not limited to selegiline, isocarboxazid, tranylcypromine, phenelzine…),
* Patient with an abnormal cardiac condition: medically significant disorders of cardiac rate and/or rhythm,
* Patient with known anaemia,
* Patient with known pulmonary disease,
* Patient with known active gastric or duodenal ulcer or a history of recurrent gastrointestinal ulcer/bleeding,
* Patient with known glaucoma,
* Patients with a prostatic hyperplasia or urinary retention,
* Patient with current or chronic history of liver disease, or known hepatic or biliary abnormalities,
* Patient with a current or chronic history of severe renal impairment (glomerular filtration below 30 mL/min),
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04622735
Study Brief:
Protocol Section:
NCT04622735