Philadelphia, Pennsylvania 19104

  • Vomiting

Purpose:

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.


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.


Study is Available At:


Original ID:

CLCT-002


NCT ID:

NCT01780428


Secondary ID:


Study Acronym:


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


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Charleston Laboratories, Inc


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

460


Enrollment Type:

Actual


Study Dates

Start Date:January 2013
Completion Date:December 2014
Completion Type:Actual
Primary Completion Date:October 2013
Primary Completion Type:Actual
Verification Date:November 2016
Last Changed Date:November 2, 2016
First Received Date:January 28, 2013

Study Outcomes

Outcome Type:Primary Outcome
Measure: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
Safety Issues:False
Description:After data has been locked.
Outcome Type:Primary Outcome
Measure: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)
Safety Issues:False
Description:After data has been locked.
Outcome Type:Secondary Outcome
Measure:Reduction of the severity of nausea in patients treated with an opioid-containing pain reliever.
Time Frame:over 6 hours
Safety Issues:False
Description:After data lock.
Outcome Type:Secondary Outcome
Measure:Reduction of vomiting in patients treated with an opioid-containing pain reliever.
Time Frame:over 6 hours
Safety Issues:False
Description:After data lock.

Study Interventions

Intervention Type:Drug
Name:Placebo
Arm Name:Placebo
Intervention Type:Drug
Name:CL-108 (hydrodocone 7.5 mg, acetaminophen 325 mg,
Arm Name:CL-108
Other Name:Norco (hydrocodone 7.5 mg, acetaminophen 325 mg)

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Placebo
Description:CL-108 formulation without API
Study Arm Type:Active Comparator
Arm Name:Norco
Description:Commercial product containing hydrocodone 7.5 mg. acetaminophen 325 mg
Study Arm Type:Experimental
Arm Name:CL-108
Description:CL-108 (hydrocodone 7.5 mg, acetaminophen 325 mg, Promethazine 12.5 mg)

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Charleston Laboratories, Inc

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 01, 2021

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