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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03657810
Recruitment Status : Completed
First Posted : September 5, 2018
Last Update Posted : July 31, 2019
Information provided by (Responsible Party):
Charleston Laboratories, Inc

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.

Condition or disease Intervention/treatment Phase
Pain Nausea Vomiting Drug: CL-108 5 mg Drug: Norco Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 349 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Acute Pain and the Prevention of Opioid-Induced Nausea and Vomiting (OINV)
Actual Study Start Date : August 2, 2017
Actual Primary Completion Date : April 16, 2018
Actual Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: CL-108 5 mg
Hydrocodone 5 mg/APAP 325 mg/promethazine 12.5 mg (CL-108 5 mg) bi-layered tablet
Drug: CL-108 5 mg
hydrocodone 5 mg/APAP 325 mg/promethazine 12.5 mg

Active Comparator: Norco
hydrocodone 5 mg/APAP 325 mg
Drug: Norco
hydrocodone 5 mg/APAP 325 mg

Placebo Comparator: Placebo
Placebo 0 mg matching CL-108
Drug: Placebo
Placebo matching CL-108

Primary Outcome Measures :
  1. OINV endpoint: Occurrence of any vomiting over 48 hours, comparing CL-108 5 mg to hydrocodone 5 mg/acetaminophen (APAP) 325 mg [ Time Frame: Up to 48 hours ]
    Vomiting Frequency Scale (VFS), a 0-to-3 ordinal scale to assess the occurrence of vomiting

  2. OINV endpoint: Use of antiemetic over 48 hours, comparing CL-108 5 mg to hydrocodone 5 mg/acetaminophen (APAP) 325 mg [ Time Frame: Up to 48 hours ]
    Uses of antiemetic documented as they occur.

  3. The sum of pain intensity differences over 48 hours (SPID48), comparing CL-108 5 mg to placebo [ Time Frame: Up to 48 hours ]

    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 Numerical Pain Intensity Rating Scale (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03657810

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United States, Arizona
Arizona Research Center
Phoenix, Arizona, United States, 85023
United States, Maryland
Pasadena, Maryland, United States, 21122
United States, Texas
Optimal Research
Austin, Texas, United States, 78705
Endeavor Clinical Research
San Antonio, Texas, United States, 78240
United States, Utah
Jean Brown Research
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
Charleston Laboratories, Inc
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Study Director: Bernard Schachtel, MD Charleston Laboratories, Inc

Additional Information:
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Responsible Party: Charleston Laboratories, Inc Identifier: NCT03657810    
Other Study ID Numbers: CLCT-018
First Posted: September 5, 2018    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Charleston Laboratories, Inc:
Additional relevant MeSH terms:
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Acute Pain
Signs and Symptoms, Digestive
Signs and Symptoms
Neurologic Manifestations
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Allergic Agents
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Anesthetics, Local