Clinical trial NCT02462811 (phase 3, status: completed)
Conditions: pain, nausea, vomiting
ICD codes: N50.82, R07.2, R07.82, R10.13, R10.33, R14.1, R52, R11.0, R11.11, R11.2, R11.10, R11.12, R11.14, R11.11, K91.0, O21.2, O21.8
Drugs: cl-108 (hydrocodone 7.5 mg, acetaminophen 325 mg, promethazine 12.5 mg), placebo, norco (hyrdocodone 7,5 mg, acetaminophen 325 mg)
SMILES: CC(CN1C2=CC=CC=C2SC2=CC=CC=C12)N(C)C, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, [H][C@@]12OC3=C(OC)C=CC4=C3[C@@]11CCN(C)[C@]([H])(C4)[C@]1([H])CCC2=O
Eligibility 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