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)
NCT ID: NCT02462811
Last Updated: 2016-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
552 participants
INTERVENTIONAL
2014-09-30
2015-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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CL-108
CL-108 hydrocodone 7.5 mg, acetaminophen 325 mg, Promethazine 12.5 mg
CL-108 (hydrocodone 7.5 mg, acetaminophen 325 mg, promethazine 12.5 mg)
Active Comparator: Norco
Commercial product containing hydrocodone 7.5 mg, acetaminophen 325 mg
Norco (hyrdocodone 7,5 mg, acetaminophen 325 mg)
Placebo
CL-108 formulation without API
Placebo
Interventions
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CL-108 (hydrocodone 7.5 mg, acetaminophen 325 mg, promethazine 12.5 mg)
Placebo
Norco (hyrdocodone 7,5 mg, acetaminophen 325 mg)
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Joseph Hazelton
INDUSTRY
Responsible Party
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Joseph Hazelton
Vice President, Regulatory Affairs
Locations
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University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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Related Links
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Charleston Website
Other Identifiers
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CLCL-003
Identifier Type: -
Identifier Source: org_study_id