Dental Pain Study of Analgesics in Patients Undergoing Molar Removal (NVK009-0001)

Nevakar

Status and phase: Completed; Phase 2

Conditions: Dental Pain

Treatments: Drug: Post-Op Placebo 1; Drug: Post-Op pregabalin; Drug: Post-Op Placebo 2; Drug: Post-Op acetaminophen; Drug: Pre-Op Placebo 1; Drug: Pre-Op pregabalin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03652818

CP-NVK009-0001

Details and patient eligibility

About

• 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.

Full description

This is a 5 arm randomized, double-blind, parallel group, single-center, placebo-controlled study to evaluate the efficacy and safety of pregabalin-acetaminophen combination in the prevention and treatment of post-surgical dental pain in healthy patients.

Subjects in every treatment arm will receive a dose 60 min prior to surgery. It is not required to receive a post-operative dose if patient does not feel pain at a scale of NRS≥ 5. Dose 2 will be given post-surgically when patients report at least moderate pain on the categorical scale and a score of ≥5 on 0-10 PI-NRS. Subsequent to dose 2, patients can request rescue analgesic at any time.

Enrollment: 115 patients

Sex: All

Ages: 17 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

115 participants in 5 patient groups

Group A

Experimental group

Description:

Pre-op Placebo 1; Post-op Placebo 1; Post-op Placebo 2

Treatment:

Drug: Pre-Op Placebo 1

Drug: Post-Op Placebo 2

Drug: Post-Op Placebo 1

Group B

Experimental group

Description:

Pre-op Placebo 1; Post-op Placebo 2; Post-op acetaminophen.

Treatment:

Drug: Post-Op acetaminophen

Drug: Pre-Op Placebo 1

Drug: Post-Op Placebo 1

Group C

Experimental group

Description:

Pre-op Placebo 1; Post-op pregabalin; Post-op Placebo 2.

Treatment:

Drug: Post-Op pregabalin

Drug: Pre-Op Placebo 1

Drug: Post-Op Placebo 2

Group D

Experimental group

Description:

Pre-op Placebo 1; Post-op pregabalin Post-op acetaminophen.

Treatment:

Drug: Post-Op pregabalin

Drug: Post-Op acetaminophen

Drug: Pre-Op Placebo 1

Group E

Experimental group

Description:

Pre-op pregabalin; Post-op Placebo 1; Post-op acetaminophen.

Treatment:

Drug: Post-Op acetaminophen

Drug: Pre-Op pregabalin

Drug: Post-Op Placebo 1