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

NCT03657810 | Completed Phase 3 Results FDA Drug

• 1 other identifier: CLCT-018
• Study Type: interventional
• Target: 349
• Locations: 1 country
• Sites: 5

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.

Conditions

Pain; Nausea; Vomiting

Keywords

Pain; Nausea; Vomiting

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With OINV Over 48 Hours

  Number and Percentage of participants With opioid-induced nausea and vomiting (OINV) who experienced any Vomiting / use of Anti-Emetic Medication Over 48 Hours

  Up to 48 hours

• The Sum of Pain Intensity Differences (on PI-NRS) Over 48 Hours (SPID48)

  The SPID48 endpoint is calculated from the PI-NRS values at baseline, every 30 minutes until hour 12, then every hour (when awake) until hour 48 as follows: * Each subsequent PI-NRS value is subtracted from the baseline PI-NRS value. * Each difference is weighted by the elapsed time from the previous PI-NRS value to the current one. * The weighed differences are summed to yield the SPID48. Summed pain intensity differences over 48 hours (SPID48) will be compared for patients treated with CL-108 5 mg and those treated with placebo. Pain intensity will be measured on a 0-10 Pain Intensity Numerical Rating Scale (PI-NRS), where 0 is "no pain" and 10 is "severe pain".

  Up to 48 hours

Secondary Outcomes (7)

• Percentage of Patients With Complete Absence of OINV (no Nausea, no Vomiting, and no Use of Anti-emetic Medication) Over 48 Hours

  Up to 48 hours

• Percentage of Patients With Any Vomiting Over 48 Hours

  Up to 48 hours

• Percentage of Patients With Any Nausea Over 48 Hours

  Up to 48 hours

• Percentage of Patients With Any Nausea or Vomiting Over 48 Hours

  Up to 48 hours

• Percentage of Patients With Any Post-discharge Nausea and Vomiting (PDNV)

  Day 3 to 7

Study Arms (3)

CL-108 5 mg

EXPERIMENTAL

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

Drug: CL-108 5 mg

Norco

ACTIVE COMPARATOR

hydrocodone 5 mg/APAP 325 mg

Drug: Norco

Placebo

PLACEBO COMPARATOR

Placebo 0 mg matching CL-108

Drug: Placebo

Interventions

CL-108 5 mg DRUG

hydrocodone 5 mg/APAP 325 mg/promethazine 12.5 mg

Also known as: hydrocodone bitartrate/ acetaminophen/ promethazine hydrochloride

CL-108 5 mg

Norco DRUG

hydrocodone 5 mg/APAP 325 mg

Also known as: hydrocodone bitartrate/ acetaminophen

Norco

Placebo DRUG

Placebo matching CL-108

Also known as: Matching Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Charleston Laboratories, Inc: lead

Study Sites (5)

Arizona Research Center

Phoenix, Arizona, 85023, United States

Location

Chesapeake

Pasadena, Maryland, 21122, United States

Location

Optimal Research

Austin, Texas, 78705, United States

Location

Endeavor Clinical Research

San Antonio, Texas, 78240, United States

Location

Jean Brown Research

Salt Lake City, Utah, 84124, United States

Location

Related Links

• Charleston Website

MeSH Terms

Conditions

Pain; Nausea; Vomiting

Interventions

Hydrocodone; Acetaminophen; Promethazine; oxycodone-acetaminophen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Propylamines; Phenothiazines; Sulfur Compounds; Heterocyclic Compounds, 3-Ring

Results Point of Contact

• Title: Bernard P. Schachtel, MD, Chief Scientific Officer
• Organization: Charleston Laboratories, Inc.

bschachtel@charlestonlabs.com

561.379.8726

Study Officials

• Bernard Schachtel, MD

  Charleston Laboratories, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2017
• First Posted: September 5, 2018
• Study Start: August 2, 2017
• Primary Completion: April 16, 2018
• Study Completion: November 30, 2018
• Last Updated: March 22, 2023
• Results First Posted: March 22, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)