Dental Pain Study of Analgesics in Patients Undergoing Molar Removal

Phase 2

Completed

• Conditions: Dental Pain
• Interventions: Drug: Pre-Op Placebo 1; Drug: Pre-Op pregabalin; Drug: Post-Op Placebo 1; Drug: Post-Op pregabalin; Drug: Post-Op Placebo 2; Drug: Post-Op acetaminophen

• Registration Number: NCT03652818
• Lead Sponsor: Nevakar, Inc.

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.

Study Timeline

• Study Start: 2018-06-15
• Study First Submitted: 2018-07-18
• Study First Submitted QC: 2018-08-27
• Study First Posted: 2018-08-29
• Primary Completion: 2018-09-20
• Study Completion: 2018-09-20
• Results First Submitted: 2021-08-28
• Status Verified: 2021-10
• Results First Submitted QC: 2021-10-25
• Last Update Submitted: 2021-10-25
• Results First Posted: 2021-11-23
• Last Update Posted: 2021-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

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.

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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.)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Post-Op Placebo 1	Pre-op Placebo 1; Post-op Placebo 1; Post-op Placebo 2
Group A	Post-Op Placebo 2	Pre-op Placebo 1; Post-op Placebo 1; Post-op Placebo 2
Group C	Post-Op pregabalin	Pre-op Placebo 1; Post-op pregabalin; Post-op Placebo 2.
Group D	Pre-Op Placebo 1	Pre-op Placebo 1; Post-op pregabalin Post-op acetaminophen.
Group D	Post-Op pregabalin	Pre-op Placebo 1; Post-op pregabalin Post-op acetaminophen.
Group B	Pre-Op Placebo 1	Pre-op Placebo 1; Post-op Placebo 2; Post-op acetaminophen.
Group B	Post-Op Placebo 1	Pre-op Placebo 1; Post-op Placebo 2; Post-op acetaminophen.
Group B	Post-Op acetaminophen	Pre-op Placebo 1; Post-op Placebo 2; Post-op acetaminophen.
Group E	Post-Op acetaminophen	Pre-op pregabalin; Post-op Placebo 1; Post-op acetaminophen.
Group A	Pre-Op Placebo 1	Pre-op Placebo 1; Post-op Placebo 1; Post-op Placebo 2
Group C	Post-Op Placebo 2	Pre-op Placebo 1; Post-op pregabalin; Post-op Placebo 2.
Group E	Post-Op Placebo 1	Pre-op pregabalin; Post-op Placebo 1; Post-op acetaminophen.
Group C	Pre-Op Placebo 1	Pre-op Placebo 1; Post-op pregabalin; Post-op Placebo 2.
Group D	Post-Op acetaminophen	Pre-op Placebo 1; Post-op pregabalin Post-op acetaminophen.
Group E	Pre-Op pregabalin	Pre-op pregabalin; Post-op Placebo 1; Post-op acetaminophen.

Primary Outcome Measures

Name	Time	Method
Total Pain Relief Measure	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)	Beginning post-surgery (at initiation of Dose 2), Pain Relief was self-reported over 24 hours, using a pain rating of 0-10 on the Numerical Rating Scale (NRS), with score between 0-10 (0= no pain; 10 = pain as bad as can be). Time-weighted sum pain total pain relief scores over 24 hours is reported Last observation carried forward method was used.
Sum Pain Intensity Difference Scores	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)	Beginning post-surgery (at initiation of Dose 2), Pain Intensity was self-reported over 24 hours, using a pain rating of 0-10 on the Numerical Rating Scale (NRS), with score between 0-10 (0= no pain; 10 = pain as bad as can be). Time weighted sum pain intensity difference scores are reported over 0 to 24 hours. Last observation carried forward method was used.

Secondary Outcome Measures

Name	Time	Method
Cumulative Number of Participants With Onset of First Perceptible Relief (FPR) Confirmed at 24 Hours After Dose 2	0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0 and 24 hours	Beginning post-surgery (at initiation of Dose 2), participants were given a stopwatch and asked to press the stopwatch if and when they feel first perceptible relief; a record of the time was noted in the participants record. Cumulative number of participants with onset of FPR confirmed after dose 2 and was recorded from 0.25 hour till 24 hours after administration of dose 2.
Cumulative Number of Participants With Onset of Meaning Pain Relief (MPR) Confirmed at 24 Hours After Dose 2	0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0 and 24 hours	Beginning post-surgery (at initiation of Dose 2), participants were given a stopwatch and asked to press the stopwatch if and when they feel first perceptible relief; a record of the time was noted in the participants record. Cumulative number of participants with onset of MPR confirmed after dose 2 and was recorded from 0.25 hour till 24 hours after administration of dose 2.
Number of Participants With Differing Patient Global Evaluation Scores	Upto 12.25 hours	Patient global evaluation was self-reported at time of first rescue or at 12.25 hours post-surgery, whichever was first, using a 0-4 categorical rating scale of: (0) poor, (1) fair, (2) good, (3) very good, and (4) excellent. The number of participants with differing patient global evaluation scores were reported.

Trial Locations

Locations (1)

Jean Brown Research; 🇺🇸 Salt Lake City, Utah, United States