Clinical trial NCT03652818: Dental Pain Study of Analgesics in Patients Undergoing Molar Removal
Official title: Randomized, Double-blind, Parallel Group, Single-center, Placebo-controlled Study to Evaluate Efficacy and Safety of Analgesic Combo in Prevention and Treatment of Post-surgical Dental Pain in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dental Pain
Lead sponsor: Nevakar, Inc.
Sponsor class: INDUSTRY
First posted: 2018-08-29
Enrollment: 115
Sex: ALL
Minimum age (years): 17
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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.)

Primary outcomes:
measure: Sum Pain Intensity Difference Scores
timeFrame: 0.5, 0.75, 1, 1.25, 1.75, 2.25 hours (± 5 min) and 3.25, 4.25, 5.25, 6.25, 8.25, 10.25, 12.25, 24 hours (± 10 min)
measure: Total Pain Relief Measure
timeFrame: 0.5, 0.75, 1, 1.25, 1.75, 2.25 hours (± 5 min) and 3.25, 4.25, 5.25, 6.25, 8.25, 10.25, 12.25, 24 hours (± 10 min)
Secondary outcomes:
measure: Number of Participants With Differing Patient Global Evaluation Scores
timeFrame: Upto 12.25 hours
measure: Cumulative Number of Participants With Onset of First Perceptible Relief (FPR) Confirmed at 24 Hours After Dose 2
timeFrame: 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0 and 24 hours
measure: Cumulative Number of Participants With Onset of Meaning Pain Relief (MPR) Confirmed at 24 Hours After Dose 2
timeFrame: 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0 and 24 hours
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
Study officials:
affiliation: Nevakar, Inc.
name: Kenneth Somberg, MD
role: STUDY_DIRECTOR
References: