A Controlled Study to Determine the Efficacy and Safety of CL-108 5 mg for Acute Pain and the Prevention of OINV
Condition: Pain; Nausea; Vomiting
MeSH terms: Nausea; Vomiting; Acute Pain
Intervention: CL-108 5 mg; Norco; Placebo
Intervention description: hydrocodone 5 mg/APAP 325 mg/promethazine 12.5 mg; hydrocodone 5 mg/APAP 325 mg; Placebo matching CL-108
Intervention MeSH terms: Acetaminophen; Promethazine; Acetaminophen, hydrocodone drug combination; Hydrocodone; Oxycodone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 349.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pain; Nausea; Vomiting

Summary:

      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.
    

Eligibility criteria:

        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.