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)

ClinicalTrials.gov ID: NCT02462811

Public ClinicalTrials.gov record NCT02462811. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Jul 21, 2026, 12:10 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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)

Study identification

NCT ID: NCT02462811
Recruitment status: Completed
Study type: Interventional
Phase: Phase 3
Lead sponsor: Joseph Hazelton; Industry
Enrollment: 552 participants

Conditions and interventions

Conditions

Interventions

CL-108 (hydrocodone 7.5 mg, acetaminophen 325 mg, promethazine 12.5 mg) Drug
Placebo Drug
Norco (hyrdocodone 7,5 mg, acetaminophen 325 mg) Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Aug 31, 2014
Primary completion: Jun 30, 2015
Completion: Jul 31, 2015
Last update posted: Nov 2, 2016

2014 – 2015

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
University of Pennsylvania	Philadelphia	Pennsylvania	19104-6030	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT02462811, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Nov 2, 2016 · Synced Jul 21, 2026

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The complete protocol, eligibility criteria, and contact information for NCT02462811 live on ClinicalTrials.gov.

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