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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)

NCT02462811 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 552

Last updated 2016-11-03

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • Joseph Hazelton

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2015-07-31
Completion
2015-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02462811 on ClinicalTrials.gov