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. (see Contacts and Locations)
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 July 29, 2014