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A Phase 2 Study to Evaluate Pregabalin and Acetaminophen Compared to Acetaminophen and Placebo in Subjects Undergoing Bunionectomy

NCT04495283 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2021-11-23

Study results available
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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

Conditions

  • Postoperative Pain

Interventions

DRUG

Pregabalin

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

DRUG

Acetaminophen

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

OTHER

Placebo 1

Placebo for APAP

OTHER

Placebo 2

Placebo for combination

Sponsors & Collaborators

  • Nevakar Injectables, Inc.

    collaborator INDUSTRY

  • Nevakar, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-28
Primary Completion
2020-11-12
Completion
2020-11-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT04495283 on ClinicalTrials.gov