NCT03657810

A Controlled Study to Determine the Efficacy and Safety of CL-108 5 mg for Acute Pain and the Prevention of OINV

A Randomized, Double-Blind, Placebo- and Active-Controlled Study to Determine the Efficacy and Safety of CL-108 5 mg (Hydrocodone 5 mg/Acetaminophen 325 mg/Promethazine 12.5 mg) as a Treatment for Moderate-to-Severe Acute Pain and the Prevention of Opioid-Induced Nausea and Vomiting (OINV) Following Orthopedic Surgery

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 349 (actual)
• Sponsor: Charleston Laboratories, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To determine the analgesic efficacy of CL-108 5 mg by comparison with placebo and the anti-emetic efficacy of CL-108 5 mg by comparison with hydrocodone 5 mg/acetaminophen 325 mg.

Detailed description

Adult patients with moderate or severe pain after bunionectomy will be randomized to CL-108 5 mg (hydrocodone 5 mg/acetaminophen 325 mg/ promethazine 12.5 mg), hydrocodone 5 mg/ acetaminophen 325 mg, or placebo under double-blind conditions. Over 48 hours they will use the assigned study medication and assess pain intensity, nausea, and vomiting. Uses of supplementary analgesic and antiemetic medications will be documented. Patient responses and adverse effects will also be documented during the 5-day outpatient period, too.

Conditions

• Pain
• Nausea
• Vomiting

Interventions

Type	Name	Description
DRUG	CL-108 5 mg	hydrocodone 5 mg/APAP 325 mg/promethazine 12.5 mg
DRUG	Norco	hydrocodone 5 mg/APAP 325 mg
DRUG	Placebo	Placebo matching CL-108

Timeline

• Start date: 2017-08-02
• Primary completion: 2018-04-16
• Completion: 2018-11-30
• First posted: 2018-09-05
• Last updated: 2023-03-22
• Results posted: 2023-03-22

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study