CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 87 enrolled
Drug / intervention
Pregabalin +3 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/NCT04495283
NCT04495283Phase 2Completed
CompareCT.gov

A Phase 2, Randomized, Double-Blind, Placebo- and Comparator-Controlled Trial to Evaluate the Safety and Efficacy of Combination of Pregabalin and Acetaminophen Compared to Acetaminophen and Placebo in Subjects Undergoing Bunionectomy

Nevakar, Inc.·interventional·Posted Jul 31, 2020·Updated Nov 23, 2021

In Brief

A Phase 2 clinical trial evaluating Pregabalin, Acetaminophen, and 2 other interventions for Postoperative Pain. Completed, enrolled 87 participants across 2 sites.

Detailed Summary

A Phase 2, Randomized, Double-Blind, Placebo- and Comparator-Controlled Trial to Evaluate the Safety and Efficacy of Combination Pregabalin and Acetaminophen Compared to Acetaminophen and Placebo in Subjects Undergoing Bunionectomy

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostoperative Pain
CountriesUnited States
CollaboratorsNevakar Injectables, Inc.

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedJul 31, 2020
Enrollment StartJul 28, 2020
Primary CompletionNov 12, 2020
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 5.9 years ago

Interventions

Pregabalindrug

Pregabalin is a structural derivative of the inhibitory neurotransmitter gamma aminobutyric acid with anticonvulsant, anxiolytic and sleep-modulating properties.

Acetaminophendrug

Acetaminophen is a non-salicylate antipyretic and non-opioid analgesic agent.

Placebo 1other

Placebo for APAP

Placebo 2other

Placebo for combination