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Dental Pain Study of Analgesics in Patients Undergoing Molar Removal

NCT03652818 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2021-11-23

Study results available
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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.

Conditions

  • Dental Pain

Interventions

DRUG

Pre-Op pregabalin

Pre-op pregabalin will be administered 60 min prior to surgery.

DRUG

Pre-Op Placebo 1

Placebo 1 will be administered 60 min prior to surgery.

DRUG

Post-Op pregabalin

Post-op pregabalin will be administered Post-operatively.

DRUG

Post-Op Placebo 1

Placebo 1 will be administered post-operatively.

DRUG

Post-Op Placebo 2

Placebo 2 will be administered post-operatively.

DRUG

Post-Op acetaminophen

Acetaminophen will be administered Post-operatively.

Sponsors & Collaborators

  • Nevakar, Inc.

    lead INDUSTRY

Principal Investigators

  • Kenneth Somberg, MD · Nevakar, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
17 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-15
Primary Completion
2018-09-20
Completion
2018-09-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03652818 on ClinicalTrials.gov