drugset
drugset / Trial / NCT04495283

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

NCT04495283 ↗

Phase 2 Completed 87 enrolled Nevakar, Inc. Nevakar Injectables, Inc. · collab
RandomizedParallel-groupTriple-blindTreatment

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

Timeline

Start
2020-07-28
Primary completion
2020-11-12
Completion
2020-11-12

Outcome

Met primary endpoint

registry analysis (superiority test); PGB and APAP (Group A) vs Placebo (Group C).; p <0.001; LS Mean Difference -114.43; ANOVA NCT04495283 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Acetaminophen Small molecule — —
Subject Pregabalin Small molecule — —

Indications

No indication recorded.