NCT04495283

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Nevakar, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Detailed description

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 Up to 80 subjects will be randomized (32 in each active treatment group, 16 placebo). To evaluate the efficacy of combination pregabalin (PGB) and acetaminophen (APAP) administered vs. placebo for pain control in subjects undergoing bunionectomy. The placebo will be the saline solution.

Conditions

• Postoperative Pain

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-07-28
• Primary completion: 2020-11-12
• Completion: 2020-11-12
• First posted: 2020-07-31
• Last updated: 2021-11-23
• Results posted: 2021-11-23

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study