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)
1 other identifier
interventional
552
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 pain
Started Sep 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 22, 2015
CompletedFirst Posted
Study publicly available on registry
June 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedNovember 3, 2016
January 1, 2016
10 months
May 22, 2015
November 2, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The occurrence of opioid-induced nausea and vomiting (OINV) as assessed by an OINV questionnaire comparing CL-108 to Norco® over 48 hours.
48 hours
The relief of moderate to severe pain, assessed by visual analog pain intensity scale, comparing CL-108 to placebo over 48 hours (SPID48).
48 hours
Secondary Outcomes (6)
The severity of opioid-induced nausea, comparing CL-108 to Norco® over 48 hours
48 hours
The occurrence of vomiting, comparing CL-108 to Norco® over 48 hours
48 hours
The use of anti-emetics, comparing CL-108 to Norco® over 48 hours.
48 hours
Incidence of post-discharge nausea and vomiting (PDNV), comparing CL-108 to placebo over days 3-5
48 hours
The relief of post-operative nausea and vomiting (PONV), comparing CL-108 to placebo over 48 hours
48 hours
- +1 more secondary outcomes
Study Arms (3)
CL-108
EXPERIMENTALCL-108 hydrocodone 7.5 mg, acetaminophen 325 mg, Promethazine 12.5 mg
Active Comparator: Norco
ACTIVE COMPARATORCommercial product containing hydrocodone 7.5 mg, acetaminophen 325 mg
Placebo
PLACEBO COMPARATORCL-108 formulation without API
Interventions
Eligibility Criteria
You may qualify if:
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Joseph Hazeltonlead
Study Sites (1)
University of Pennsylvania
Philadelphia, Pennsylvania, 19104-6030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Vice President, Regulatory Affairs
Study Record Dates
First Submitted
May 22, 2015
First Posted
June 4, 2015
Study Start
September 1, 2014
Primary Completion
July 1, 2015
Study Completion
August 1, 2015
Last Updated
November 3, 2016
Record last verified: 2016-01