NCT02462811

A Double-Blind, Randomized, Active- and Placebo-Controlled, Multiple-Dose Multi-Center Phase 3 Study of the Safety and Efficacy of CL-108 in the Treatment of Moderate to Severe Acute Pain and Opioid-Induced Nausea and Vomiting (OINV)

A Double-Blind, Randomized, Active- and Placebo-Controlled, Multiple-Dose, Multi-Center Phase 3 Study of the Safety and Efficacy of CL-108 in the Treatment of Moderate to Severe Pain and Opioid-Induced Nausea and Vomiting (OINV)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 552 (actual)
• Sponsor: Joseph Hazelton · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objectives of this study are to compare the occurrence and severity of opioid-induced nausea and vomiting (OINV) associated with CL-108 to Norco®, and to demonstrate the efficacy of CL-108 when compared to placebo for the relief of moderate to severe pain In patients with moderate to severe pain following bunionectomy (osteotomy with fixation of the head of the first metatarsal bone).

Conditions

• Pain
• Nausea
• Vomiting

Interventions

Type	Name	Description
DRUG	CL-108 (hydrocodone 7.5 mg, acetaminophen 325 mg, promethazine 12.5 mg)
DRUG	Placebo
DRUG	Norco (hyrdocodone 7,5 mg, acetaminophen 325 mg)

Timeline

• Start date: 2014-09-01
• Primary completion: 2015-07-01
• Completion: 2015-08-01
• First posted: 2015-06-04
• Last updated: 2016-11-03

Locations

1 site across 1 country: United States