A Controlled Study to Determine the Efficacy and Safety of CL-108 5 mg for Acute Pain and the Prevention of OINV

Charleston Laboratories

Status and phase: Completed; Phase 3

Conditions: Vomiting; Nausea; Pain

Treatments: Drug: CL-108 5 mg; Drug: Placebo; Drug: Norco

Study type: Interventional

Funder types: Industry

Identifiers

NCT03657810

CLCT-018

Details and patient eligibility

About

To determine the analgesic efficacy of CL-108 5 mg by comparison with placebo and the anti-emetic efficacy of CL-108 5 mg by comparison with hydrocodone 5 mg/acetaminophen 325 mg.

Full description

Adult patients with moderate or severe pain after bunionectomy will be randomized to CL-108 5 mg (hydrocodone 5 mg/acetaminophen 325 mg/ promethazine 12.5 mg), hydrocodone 5 mg/ acetaminophen 325 mg, or placebo under double-blind conditions. Over 48 hours they will use the assigned study medication and assess pain intensity, nausea, and vomiting. Uses of supplementary analgesic and antiemetic medications will be documented. Patient responses and adverse effects will also be documented during the 5-day outpatient period, too.

Enrollment: 349 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Informed consent: Signed informed consent form obtained at screening prior to any procedures being performed.
• Gender: Male or non-pregnant and non-lactating female.
• Age: 18 years or older at time of consent.
• Foot condition: Primary unilateral first metatarsal bunionectomy (osteotomy and internal fixation) with no additional collateral procedures.
• Pain Severity: Presence of moderate or severe pain on a categorical pain intensity scale at Baseline
• Pain Confirmation: On the 0-10 numerical pain intensity scale at Baseline.
• Diary Completion: Be willing and able to record safety and efficacy ratings in the Diaries.
• Safe Transportation Home: Patient must have arrangements for transportation home from the research center accompanied by a responsible adult.

Exclusion criteria

• Medical condition: Presence of a serious medical condition, intolerance to NSAIDs, or any other medical condition which, in the opinion of the Investigator, makes the patient unsuitable for participation.
• Infection: Acute infection of the surgical site at the time of surgery that could confound post-surgical evaluation.
• Drug Allergy: History of hypersensitivity to an opioid drug (such as hydrocodone), promethazine, acetaminophen, NSAID (such as ibuprofen or aspirin), midazolam, propofol, mepivacaine, ropivacaine or ketorolac.
• Confounding and Contraindicated Drugs: Other than protocol-permitted medications administered pre-operatively or during surgery: use within 14 days before or during the surgical procedure of any systemic corticosteroid or use within 24 hours or during the surgical procedure of any confounding prescription or non-prescription drug or any drug contraindicated with hydrocodone, acetaminophen, or promethazine. [Note: Antibiotic for endocarditis prophylaxis (except if known to cause nausea) and aspirin (ASA) ≤ 325 mg for cardiovascular prophylaxis are permitted during the study.] History of consuming more than 2 alcoholic drinks per day every day for the last month or a positive urine test for opiates, benzodiazepines, barbiturates, tetrahydrocannabinol, methamphetamines, cocaine, oxycodone, cotinine at screening or the morning of surgery will exclude the patient from the trial.
• Investigational 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.
• Compliance: Inability to swallow capsules whole.
• Participant relationship: Employee at the research center, employee of the Principal Investigator, Sub-Investigators, or sponsor or relative of the Investigator, Sub-Investigators or research staff who is involved in this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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349 participants in 3 patient groups, including a placebo group

CL-108 5 mg

Experimental group

Description:

Hydrocodone 5 mg/APAP 325 mg/promethazine 12.5 mg (CL-108 5 mg) bi-layered tablet

Treatment:

Drug: CL-108 5 mg

Norco

Active Comparator group

Description:

hydrocodone 5 mg/APAP 325 mg

Treatment:

Drug: Norco

Placebo

Placebo Comparator group

Description:

Placebo 0 mg matching CL-108

Treatment:

Drug: Placebo