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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01780428
• Other study ID #: CLCT-002
• Status: Completed
• Phase: Phase 3
• First received: January 28, 2013
• Last updated: November 2, 2016
• Start date: January 2013
• Est. completion date: December 2014

Study information

• Verified date: November 2016
• Source: Charleston Laboratories, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 460
• Est. completion date: December 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Nausea
• Pain
• Vomiting

Intervention

Drug:
• CL-108 (hydrodocone 7.5 mg, acetaminophen 325 mg, promethazine 12.5 mg)

• Placebo

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Charleston Laboratories, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Elimination of vomiting in patients treated with an opioid-containing pain reliever.	After data lock.	6 hours and 24 hours	No
Other	Elimination of nausea in patients treated with an opioid-containing pain reliever.	After data lock.	6 hours and 24 hours	No
Primary	To compare the occurrence and severity of opioid-induced nausea and vomiting (OINV) associated with CL-108 to Norco.	After data has been locked.	Over the first 24 hours	No
Primary	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.	over 24 hours (SPID24)	No
Secondary	Reduction of the severity of nausea in patients treated with an opioid-containing pain reliever.	After data lock.	over 6 hours	No
Secondary	Reduction of vomiting in patients treated with an opioid-containing pain reliever.	After data lock.	over 6 hours	No

External Links

•   Charleston Website