NCT02462811View on ClinicalTrials.gov

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)

PHASE3CompletedINTERVENTIONAL
Enrollment

552

Participants

Timeline

Start Date

September 30, 2014

Primary Completion Date

July 31, 2015

Study Completion Date

August 31, 2015

Conditions
PainNauseaVomiting
Interventions
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)

Trial Locations (1)

19104-6030

University of Pennsylvania, Philadelphia

All Listed Sponsors
lead

Joseph Hazelton

INDUSTRY

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) | Biotech Hunter | Biotech Hunter