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A Double-Blind, Randomized, Active- and Placebo-Controlled, Multiple-Dose Multi-Center Phase 3 Study of the Safety and Efficacy of CL-108 in the Treatment of Moderate to Severe Acute Pain and Opioid-Induced Nausea and Vomiting (OINV)

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ClinicalTrials.gov Identifier: NCT02462811
Recruitment Status : Completed
First Posted : June 4, 2015
Last Update Posted : November 3, 2016
Sponsor:
Information provided by (Responsible Party):
Joseph Hazelton, Charleston Laboratories, Inc

Brief Summary:
The objectives of this study are to compare the occurrence and severity of opioid-induced nausea and vomiting (OINV) associated with CL-108 to Norco®, and to demonstrate the efficacy of CL-108 when compared to placebo for the relief of moderate to severe pain In patients with moderate to severe pain following bunionectomy (osteotomy with fixation of the head of the first metatarsal bone).

Condition or disease Intervention/treatment Phase
Pain Nausea Vomiting Drug: CL-108 (hydrocodone 7.5 mg, acetaminophen 325 mg, promethazine 12.5 mg) Drug: Placebo Drug: Norco (hyrdocodone 7,5 mg, acetaminophen 325 mg) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 552 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Active- and Placebo-Controlled, Multiple-Dose, Multi-Center Phase 3 Study of the Safety and Efficacy of CL-108 in the Treatment of Moderate to Severe Pain and Opioid-Induced Nausea and Vomiting (OINV)
Study Start Date : September 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Chlorine

Arm Intervention/treatment
Experimental: CL-108
CL-108 hydrocodone 7.5 mg, acetaminophen 325 mg, Promethazine 12.5 mg
Drug: CL-108 (hydrocodone 7.5 mg, acetaminophen 325 mg, promethazine 12.5 mg)
Active Comparator: Active Comparator: Norco
Commercial product containing hydrocodone 7.5 mg, acetaminophen 325 mg
Drug: Norco (hyrdocodone 7,5 mg, acetaminophen 325 mg)
Placebo Comparator: Placebo
CL-108 formulation without API
Drug: Placebo



Primary Outcome Measures :
  1. The occurrence of opioid-induced nausea and vomiting (OINV) as assessed by an OINV questionnaire comparing CL-108 to Norco® over 48 hours. [ Time Frame: 48 hours ]
  2. The relief of moderate to severe pain, assessed by visual analog pain intensity scale, comparing CL-108 to placebo over 48 hours (SPID48). [ Time Frame: 48 hours ]

Secondary Outcome Measures :
  1. The severity of opioid-induced nausea, comparing CL-108 to Norco® over 48 hours [ Time Frame: 48 hours ]
  2. The occurrence of vomiting, comparing CL-108 to Norco® over 48 hours [ Time Frame: 48 hours ]
  3. The use of anti-emetics, comparing CL-108 to Norco® over 48 hours. [ Time Frame: 48 hours ]
  4. Incidence of post-discharge nausea and vomiting (PDNV), comparing CL-108 to placebo over days 3-5 [ Time Frame: 48 hours ]
  5. The relief of post-operative nausea and vomiting (PONV), comparing CL-108 to placebo over 48 hours [ Time Frame: 48 hours ]
  6. The relief of severe pain, comparing CL-108 to Norco® over 48 hours, i.e., summed pain intensity differences over 48 hours (SPID48) [ Time Frame: 48 hours ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA

  • Informed Consent: Signed consent obtained at screening prior to any procedures being performed.
  • Gender: Male or non-pregnant and non-lactating female. 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 (i.e., oral, transdermal, or implanted contraceptives, intrauterine device, diaphragm, condom, abstinence, or surgical sterilization)
  • Age: 18 years or older
  • OINV Status: At risk of OINV on the Nausea Prone Questionnaire (NPQ)
  • Foot Condition: Surgical extraction of a unilateral first metatarsal bunion confirmed by foot x-ray (assessed by surgeon prior to surgery)
  • Pain Severity: Presence of moderate or severe pain (i.e., ≥ 4 on the baseline numerical pain intensity rating scale [PI-NRS])
  • Pain Confirm: Rating ≥ 50 mm on the baseline visual analog pain intensity scale (PI-VAS)
  • Diary Completion: Be willing and able to record safety and efficacy information in the In-patient and Outpatient Diaries
  • Safe Transportation: Patient must have arrangements for transportation home from the research center accompanied by a responsible adult

EXLUSION CRITERIA

  • Medical Condition: Presence of a serious medical condition (e.g., poorly controlled hypertension or diabetes, neurological disease including Parkinson's or other condition associated with a movement disorder, significantly impaired cardiac, renal, hepatic, respiratory, or thyroid function)
  • Infection: Acute local infection at the time of surgery that could confound post-surgical evaluation.
  • Drug Allergy: History of hypersensitivity or allergy to an opioid drug such as hydrocodone, promethazine, acetaminophen, ondansetron, NSAID (such as ibuprofen, including aspirin) or ketorolac or history of a dystonic/dyskinetic reaction to prior anti-emetic or anti-psychotic medication
  • Contraindicated Drugs: Use (within 24 hours of the surgical procedure) of any confounding prescription or non-prescription drug (e.g., analgesic, anti-emetic, sedating antihistamine, sedative, alcohol, CNS/psychotropic agent, including sleep aides, benzodiazepines, performance/attention enhancers, marijuana, anti-depressants) or any drug contraindicated with hydrocodone, acetaminophen, or promethazine (except for pre-op medications). Antibiotic prophylaxis for endocarditis (except if known to cause nausea) and ASA 62.5 mg for cardiovascular prophylaxis are permitted during the study.
  • History of drug or alcohol abuse
  • Caffeine Use: Ingestion of any caffeine-containing beverage or chocolate since mid-night before the operation
  • Investigation Drug Use: Use of an investigational drug within the past 30 days
  • Participated in Study:Previous participation in this study
  • Pregnancy, Lactation: Women who are pregnant or lactating
  • Participant Relation: Employee at the research center or of Charleston Laboratories or relative of the Principal Investigator, Sub-Investigators, or research staff who is directly involved in this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02462811


Locations
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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-6030
Sponsors and Collaborators
Joseph Hazelton

Additional Information:
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Responsible Party: Joseph Hazelton, Vice President, Regulatory Affairs, Charleston Laboratories, Inc
ClinicalTrials.gov Identifier: NCT02462811    
Other Study ID Numbers: CLCL-003
First Posted: June 4, 2015    Key Record Dates
Last Update Posted: November 3, 2016
Last Verified: January 2016
Keywords provided by Joseph Hazelton, Charleston Laboratories, Inc:
Pain
Nausea
Vomiting
Additional relevant MeSH terms:
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Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Acetaminophen
Promethazine
Diphenhydramine
Hydrocodone
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Antipruritics
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Allergic Agents
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Anesthetics, Local