NCT04495283View on ClinicalTrials.gov

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

PHASE2CompletedINTERVENTIONAL
Enrollment

87

Participants

Timeline

Start Date

July 28, 2020

Primary Completion Date

November 12, 2020

Study Completion Date

November 12, 2020

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

Trial Locations (2)

77401

Lotus HD Research, Bellaire

91105

Lotus Clinical Resarch,LLC, Pasadena

Sponsors

Lead Sponsor

Nevakar, Inc.
All Listed Sponsors
collaborator

Nevakar Injectables, Inc.

INDUSTRY

lead

Nevakar, Inc.

INDUSTRY

NCT04495283 - A Phase 2 Study to Evaluate Pregabalin and Acetaminophen Compared to Acetaminophen and Placebo in Subjects Undergoing Bunionectomy | Biotech Hunter | Biotech Hunter