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

• Status: Completed
• Trial end date: 2018-11-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Charleston Laboratories, Inc
• Treatments: Diphenhydramine; Hydrocodone; Promethazine

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.