CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 115 enrolled
Drug / intervention
Pre-Op pregabalin +5 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03652818
NCT03652818Phase 2Completed

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

Nevakar, Inc.·interventional·Posted Aug 29, 2018·Updated Nov 23, 2021

In Brief

A Phase 2 clinical trial evaluating Pre-Op pregabalin, Pre-Op Placebo 1, and 4 other interventions for Dental Pain. Completed, enrolled 115 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDental Pain
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedAug 29, 2018
Enrollment StartJun 15, 2018
Primary CompletionSep 20, 2018
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 7.8 years ago

Interventions

Pre-Op pregabalindrug

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

Pre-Op Placebo 1drug

Placebo 1 will be administered 60 min prior to surgery.

Post-Op pregabalindrug

Post-op pregabalin will be administered Post-operatively.

Post-Op Placebo 1drug

Placebo 1 will be administered post-operatively.

Post-Op Placebo 2drug

Placebo 2 will be administered post-operatively.

Post-Op acetaminophendrug

Acetaminophen will be administered Post-operatively.