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

This study is currently recruiting participants.
Verified January 2013 by Charleston Laboratories, Inc
Sponsor:
Information provided by (Responsible Party):
John Ameling, Charleston Laboratories, Inc
ClinicalTrials.gov Identifier:
NCT01780428
First received: January 28, 2013
Last updated: January 30, 2013
Last verified: January 2013
History of Changes
  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 severs pain following surgical removal of impacted third molar teeth.

A positive control ( Norco, A commercial formulation of hydrocodone 7.5 mg/APAP 325 mg) is included to determine the anti-emetic effects of CL-108.


Condition Intervention Phase
Pain
Nausea
Vomiting
 Drug: CL-108
Drug: Placebo
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Charleston Laboratories, Inc:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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. [ Time Frame: over 24 hours (SPID24) ] [ Designated as safety issue: No ]
    After data has been locked.


Secondary Outcome Measures:
  • Reduction of the severity of nausea in patients treated with an opioid-containing pain reliever. [ Time Frame: over 6 hours ] [ Designated as safety issue: No ]
    After data lock.

  • Reduction of vomiting in patients treated with an opioid-containing pain reliever. [ Time Frame: over 6 hours ] [ Designated as safety issue: No ]
    After data lock.


Other Outcome Measures:
  • Elimination of vomiting in patients treated with an opioid-containing pain reliever. [ Time Frame: 6 hours and 24 hours ] [ Designated as safety issue: No ]
    After data lock.

  • Elimination of nausea in patients treated with an opioid-containing pain reliever. [ Time Frame: 6 hours and 24 hours ] [ Designated as safety issue: No ]
    After data lock.


Estimated Enrollment: 810
Study Start Date: January 2013
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CL-108
CL-108 hydrocodone 7.5 mg,APAP 325 mg, Promethazine 12.5 mg
 Drug: CL-108
Other Names:
  • Norco
  • Placebo
Active Comparator: Norco
Commercial product containing hydrocodone 7.5 mg. APAP 325 mg
 Drug: CL-108
Other Names:
  • Norco
  • Placebo
Placebo Comparator: Placebo
CL-108 formulation without API
 Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01780428

Contacts
Contact: Benard P Schachtel, M.D. 5615757330 bschachlet@charlestonlabs.com

Locations
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104-6030
Contact: Stacey A Secreto, Med. Tech.     215-746-8871        
Principal Investigator: Elliot V HErsh, D.M.D.            
Sponsors and Collaborators
Charleston Laboratories, Inc
  More Information

Additional Information:
Charleston Website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: John Ameling, Vice-President, Charleston Laboratories, Inc
ClinicalTrials.gov Identifier: NCT01780428     History of Changes
Other Study ID Numbers: CLCT-002
Study First Received: January 28, 2013
Last Updated: January 30, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Charleston Laboratories, Inc:
Pain
Nausea
Vomiting

Additional relevant MeSH terms:
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013