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

NCT03657810 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 349

Last updated 2023-03-22

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Charleston Laboratories, Inc

    lead INDUSTRY

Principal Investigators

  • Bernard Schachtel, MD · Charleston Laboratories, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-02
Primary Completion
2018-04-16
Completion
2018-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03657810 on ClinicalTrials.gov