Overview

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.)