Dental Pain Study of Analgesics in Patients Undergoing Molar Removal

• Status: Completed
• Trial end date: 2018-09-20
• Target enrollment: 0
• Participant gender: All

Summary

• Accessing the efficacy and safety of pregabalin when used alone and in combo with acetaminophen in a dental pain model.

• To test whether pre-operative dose of pregabalin increases the time to significant post-operative pain (NRS ≥ 5), and hence time to first analgesia consumed post-operatively.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Nevakar, Inc.; Nevakar, LLC
• Treatments: Acetaminophen; Analgesics; Pregabalin

Criteria

Inclusion Criteria:

• Patients who are scheduled to undergo the surgical removal of up to 4 third molars of which at least 2 have to be mandibular molars with a difficulty rating of 4 or 5.

• Patient must have a negative urine drug screen for drugs of abuse (including tobacco) at screening and at the day of surgery.

• No alcohol for a minimum of 1 day prior to the surgery.

Exclusion Criteria:

• Patients should not be experiencing oral infections or symptoms of concomitant illness at the time of a scheduled surgery.

• Patients with a history of any type of malignancy within the past 5 years other than minor skin related cancers.

• Patients who currently have or have had a history of uncontrolled hypertension.

• Patients with a known allergy or hypersensitivity to any local anesthetic drug, NSAIDs, gabapentin or pregabalin;.

• Patients with conditions that affect the absorption, metabolism, or passage of drugs out of the body (e.g., sprue, celiac disease, crohn's disease, etc.)