Phase III Study of the Safety and Efficacy of Cl-108 in the Treatment of Moderate to Severe Pain

November 2, 2016 updated by: Charleston Laboratories, Inc

A Double-Blind, Randomized, Placebo-Controlled, Multiple-dose Multi-Center Phase III Study of the Safety and Efficacy of Cl-108 in the Treatment of Moderate to Severe Pain

This is a double-blind, randomized, multiple-dose, placebo- and positive-controlled study of CL-108 (hydrocodone 7.5 mg/APAP 325 mg, promethazine 12.5 mg) in patients with moderate to severe pain following surgical removal of impacted third molar teeth.

A positive control ( Norco, a commercial formulation of hydrocodone 7.5 mg/APAP 325 mg) was included to determine the anti-emetic effects of CL-108. The efficacy of CL-108 was also evaluated to placebo for the relief of pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

460

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104-6030
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Determination of being likely or possibly nausea-prone.
  • Male or non-pregnant and non-lactating female.
  • Surgical extraction of at least 2 impacted third molar teeth
  • A female of child-bearing potential is eligible to participate in this study if she has a negative urine pregnancy test and is using an acceptable method of birth control.
  • Surgical extraction of at least 2 impacted third molar teeth.
  • Presence of at least moderate post-operative pain.

Exclusion Criteria:

  • Medial Condition, presence of a serious medical condition.
  • Active local infection.
  • Drug Allergy history of hypersensitivity to an Opioid, Promethazine, Acetaminophen.
  • Caffeine use since midnight before the operation.
  • Use of an IND Drug within past 30 days.
  • Previous participation in this study.
  • Pregnant or lactating.
  • Employee of the PI,sub-investigator or Charleston Labs or relative of an employee.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CL-108
CL-108 (hydrocodone 7.5 mg, acetaminophen 325 mg, Promethazine 12.5 mg)
Drug: CL-108 (hydrodocone 7.5 mg, acetaminophen 325 mg, promethazine 12.5 mg)
Other Names:
  • Placebo
  • Norco (hydrocodone 7.5 mg, acetaminophen 325 mg)
Active Comparator: Norco
Commercial product containing hydrocodone 7.5 mg. acetaminophen 325 mg
Drug: CL-108 (hydrodocone 7.5 mg, acetaminophen 325 mg, promethazine 12.5 mg)
Other Names:
  • Placebo
  • Norco (hydrocodone 7.5 mg, acetaminophen 325 mg)
Placebo Comparator: Placebo
CL-108 formulation without API
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare the occurrence and severity of opioid-induced nausea and vomiting (OINV) associated with CL-108 to Norco.
Time Frame: Over the first 24 hours
After data has been locked.
Over the first 24 hours
To demonstrate the efficacy of CL-108 when compared to placebo for the relief of pain following surgical removal of impacted third molar teeth.
Time Frame: over 24 hours (SPID24)
After data has been locked.
over 24 hours (SPID24)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of the severity of nausea in patients treated with an opioid-containing pain reliever.
Time Frame: over 6 hours
After data lock.
over 6 hours
Reduction of vomiting in patients treated with an opioid-containing pain reliever.
Time Frame: over 6 hours
After data lock.
over 6 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Elimination of vomiting in patients treated with an opioid-containing pain reliever.
Time Frame: 6 hours and 24 hours
After data lock.
6 hours and 24 hours
Elimination of nausea in patients treated with an opioid-containing pain reliever.
Time Frame: 6 hours and 24 hours
After data lock.
6 hours and 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charleston Laboratories, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

January 28, 2013

First Submitted That Met QC Criteria

January 30, 2013

First Posted (Estimate)

January 31, 2013

Study Record Updates

Last Update Posted (Estimate)

November 3, 2016

Last Update Submitted That Met QC Criteria

November 2, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLCT-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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