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

Primary Purpose

Pain, Nausea, Vomiting

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
CL-108 (hydrodocone 7.5 mg, acetaminophen 325 mg, promethazine 12.5 mg)
Placebo
Sponsored by
Charleston Laboratories, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain focused on measuring Pain, Nausea, Vomiting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

CL-108

Norco

Placebo

Arm Description

CL-108 (hydrocodone 7.5 mg, acetaminophen 325 mg, Promethazine 12.5 mg)

Commercial product containing hydrocodone 7.5 mg. acetaminophen 325 mg

CL-108 formulation without API

Outcomes

Primary Outcome Measures

To compare the occurrence and severity of opioid-induced nausea and vomiting (OINV) associated with CL-108 to Norco.
After data has been locked.
To demonstrate the efficacy of CL-108 when compared to placebo for the relief of pain following surgical removal of impacted third molar teeth.
After data has been locked.

Secondary Outcome Measures

Reduction of the severity of nausea in patients treated with an opioid-containing pain reliever.
After data lock.
Reduction of vomiting in patients treated with an opioid-containing pain reliever.
After data lock.

Full Information

First Posted
January 28, 2013
Last Updated
November 2, 2016
Sponsor
Charleston Laboratories, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01780428
Brief Title
Phase III Study of the Safety and Efficacy of Cl-108 in the Treatment of Moderate to Severe Pain
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Charleston Laboratories, Inc

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Nausea, Vomiting
Keywords
Pain, Nausea, Vomiting

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
460 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CL-108
Arm Type
Experimental
Arm Description
CL-108 (hydrocodone 7.5 mg, acetaminophen 325 mg, Promethazine 12.5 mg)
Arm Title
Norco
Arm Type
Active Comparator
Arm Description
Commercial product containing hydrocodone 7.5 mg. acetaminophen 325 mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
CL-108 formulation without API
Intervention Type
Drug
Intervention Name(s)
CL-108 (hydrodocone 7.5 mg, acetaminophen 325 mg, promethazine 12.5 mg)
Other Intervention Name(s)
Norco (hydrocodone 7.5 mg, acetaminophen 325 mg), Placebo
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
To compare the occurrence and severity of opioid-induced nausea and vomiting (OINV) associated with CL-108 to Norco.
Description
After data has been locked.
Time Frame
Over the first 24 hours
Title
To demonstrate the efficacy of CL-108 when compared to placebo for the relief of pain following surgical removal of impacted third molar teeth.
Description
After data has been locked.
Time Frame
over 24 hours (SPID24)
Secondary Outcome Measure Information:
Title
Reduction of the severity of nausea in patients treated with an opioid-containing pain reliever.
Description
After data lock.
Time Frame
over 6 hours
Title
Reduction of vomiting in patients treated with an opioid-containing pain reliever.
Description
After data lock.
Time Frame
over 6 hours
Other Pre-specified Outcome Measures:
Title
Elimination of vomiting in patients treated with an opioid-containing pain reliever.
Description
After data lock.
Time Frame
6 hours and 24 hours
Title
Elimination of nausea in patients treated with an opioid-containing pain reliever.
Description
After data lock.
Time Frame
6 hours and 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-6030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.charlestonlabs.com
Description
Charleston Website

Learn more about this trial

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

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