Clinical trial NCT03657810: A Controlled Study to Determine the Efficacy and Safety of CL-108 5 mg for Acute Pain and the Prevention of OINV
Official title: A Randomized, Double-Blind, Placebo- and Active-Controlled Study to Determine the Efficacy and Safety of CL-108 5 mg (Hydrocodone 5 mg/Acetaminophen 325 mg/Promethazine 12.5 mg) as a Treatment for Moderate-to-Severe Acute Pain and the Prevention of Opioid-Induced Nausea and Vomiting (OINV) Following Orthopedic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Nausea
Vomiting
Keywords: Pain
Nausea
Vomiting
Lead sponsor: Charleston Laboratories, Inc
Sponsor class: INDUSTRY
First posted: 2018-09-05
Enrollment: 349
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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.

Primary outcomes:
measure: Percentage of Participants With OINV Over 48 Hours
timeFrame: Up to 48 hours
measure: The Sum of Pain Intensity Differences (on PI-NRS) Over 48 Hours (SPID48)
timeFrame: Up to 48 hours
Secondary outcomes:
measure: Percentage of Patients With Complete Absence of OINV (no Nausea, no Vomiting, and no Use of Anti-emetic Medication) Over 48 Hours
timeFrame: Up to 48 hours
measure: Percentage of Patients With Any Vomiting Over 48 Hours
timeFrame: Up to 48 hours
measure: Percentage of Patients With Any Nausea Over 48 Hours
timeFrame: Up to 48 hours
measure: Percentage of Patients With Any Nausea or Vomiting Over 48 Hours
timeFrame: Up to 48 hours
measure: Percentage of Patients With Any Post-discharge Nausea and Vomiting (PDNV)
timeFrame: Day 3 to 7
measure: Number of Doses of Study Medication Taken Over Days 3to7
timeFrame: Day3 to Day7
measure: Number of Doses of Study Medication Taken Per Day Over Days 3to7
timeFrame: Day3 to Day7
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Pasadena
country: United States
facility: Chesapeake
state: Maryland
city: Austin
country: United States
facility: Optimal Research
state: Texas
city: San Antonio
country: United States
facility: Endeavor Clinical Research
state: Texas
city: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
Study officials:
affiliation: Charleston Laboratories, Inc
name: Bernard Schachtel, MD
role: STUDY_DIRECTOR
References: