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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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Charleston Laboratories, Inc
ClinicalTrials.gov Identifier:
NCT01780428
First received: January 28, 2013
Last updated: November 2, 2016
Last verified: November 2016
  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.


Condition Intervention Phase
Pain
Nausea
Vomiting
Drug: CL-108 (hydrodocone 7.5 mg, acetaminophen 325 mg, promethazine 12.5 mg)
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.


Enrollment: 460
Study Start Date: January 2013
Study Completion Date: December 2014
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, acetaminophen 325 mg, Promethazine 12.5 mg)
Drug: CL-108 (hydrodocone 7.5 mg, acetaminophen 325 mg, promethazine 12.5 mg)
Other Names:
  • Norco (hydrocodone 7.5 mg, acetaminophen 325 mg)
  • Placebo
Active Comparator: Norco
Commercial product containing hydrocodone 7.5 mg. acetaminophen 325 mg
Drug: CL-108 (hydrodocone 7.5 mg, acetaminophen 325 mg, promethazine 12.5 mg)
Other Names:
  • Norco (hydrocodone 7.5 mg, acetaminophen 325 mg)
  • Placebo
Placebo Comparator: Placebo
CL-108 formulation without API
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-6030
Sponsors and Collaborators
Charleston Laboratories, Inc
  More Information

Additional Information:
Responsible Party: Charleston Laboratories, Inc
ClinicalTrials.gov Identifier: NCT01780428     History of Changes
Other Study ID Numbers: CLCT-002 
Study First Received: January 28, 2013
Last Updated: November 2, 2016
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
Acetaminophen
Hydrocodone
Diphenhydramine
Promethazine
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Antipruritics
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Allergic Agents
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Hypnotics and Sedatives
Analgesics, Opioid

ClinicalTrials.gov processed this record on December 09, 2016