PainPhase 3NCT03657810
A Controlled Study to Determine the Efficacy and Safety of CL-108 5 mg for Acute Pain and the Prevention of OINV
A Phase 3 study testing CL-108 5 mg and Norco in people with Pain and Nausea, run by Charleston Laboratories, Inc at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- CL-108 5 mg and Norco
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 349 participants
- Where
- 5 sitesUnited States
- Study dates
- 2 Aug 2017to 30 Nov 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Optimal Research
Austin, Texas, 78705
Chesapeake
Pasadena, Maryland, 21122
Arizona Research Center
Phoenix, Arizona, 85023
Jean Brown Research
Salt Lake City, Utah, 84124
Endeavor Clinical Research
San Antonio, Texas, 78240
About this study
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
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.
Read the 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.
- Being tested
- CL-108 5 mg, Norco, Placebo
- Keywords
- Pain, Nausea, Vomiting
- Medical subject headings
- Pain, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CL-108 5 mgDrug
Also called hydrocodone bitartrate/ acetaminophen/ promethazine hydrochloride
hydrocodone 5 mg/APAP 325 mg/promethazine 12.5 mg
NorcoDrug
Also called hydrocodone bitartrate/ acetaminophen
hydrocodone 5 mg/APAP 325 mg
PlaceboDrug
Also called Matching Placebo
Placebo matching CL-108
| Study group | Role | What they receive |
|---|---|---|
| CL-108 5 mg | Experimental | Hydrocodone 5 mg/APAP 325 mg/promethazine 12.5 mg (CL-108 5 mg) bi-layered tablet Receives: Drug: CL-108 5 mg |
| Norco | Active comparator | hydrocodone 5 mg/APAP 325 mg Receives: Drug: Norco |
| Placebo | Placebo comparator | Placebo 0 mg matching CL-108 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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".
Measured: 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
Percentage of patients with complete absence of OINV (no nausea, no vomiting, and no use of anti-emetic medication) over 48 hours comparing CL-108 5 mg to hydrocodone 5 mg/APAP 325 mg)
Measured: Up to 48 hours
Percentage of Patients With Any Vomiting Over 48 Hours
Percentage of patients with any vomiting over 48 hours, comparing CL-108 5 mg to hydrocodone 5 mg/APAP 325 mg
Measured: Up to 48 hours
Percentage of Patients With Any Nausea Over 48 Hours
Percentage of patients with any nausea over 48 hours, comparing CL-108 5 mg to hydrocodone 5 mg/APAP 325 mg
Measured: Up to 48 hours
Percentage of Patients With Any Nausea or Vomiting Over 48 Hours
Percentage of patients with any nausea or vomiting over 48 hours, comparing CL-108 5 mg to hydrocodone 5 mg/APAP 325 mg
Measured: Up to 48 hours
Percentage of Patients With Any Post-discharge Nausea and Vomiting (PDNV)
Percentage of patients with any Post-discharge Nausea and Vomiting (PDNV) over Days 3 to 7
Measured: Day 3 to 7
Number of Doses of Study Medication Taken Over Days 3to7
Number of doses of study medication taken over Days 3 to 7
Measured: Day3 to Day7
Number of Doses of Study Medication Taken Per Day Over Days 3to7
Number of doses of study medication taken per day over Days 3 to 7
Measured: Day3 to Day7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start2 Aug 2017
- Primary completion16 Apr 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 349 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charleston Laboratories, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bernard Schachtel, MD, Study director, Charleston Laboratories, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03657810
- Sponsor's protocol ID
- CLCT-018
- Status last verified
- Feb 2023
- First submitted
- 5 Dec 2017
- Last updated
- 22 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03657810
- Acronym / sponsor ID
- CLCT-018
- Keywords
- Pain, Nausea, Vomiting
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 349 participants (actual)
- Lead sponsor
- Charleston Laboratories, IncIndustry (pharma, biotech, devices)
- Study start
- 2 Aug 2017 (actual)
- Primary completion
- 16 Apr 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 5 Sep 2018 (actual)
- Results
- Posted 22 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CL-108 5 mg | Experimental | Drug: CL-108 5 mgHydrocodone 5 mg/APAP 325 mg/promethazine 12.5 mg (CL-108 5 mg) bi-layered tablet |
| Norco | Active comparator | Drug: Norcohydrocodone 5 mg/APAP 325 mg |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 0 mg matching CL-108 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CL-108 5 mgAlso: hydrocodone bitartrate/ acetaminophen/ promethazine hydrochloridehydrocodone 5 mg/APAP 325 mg/promethazine 12.5 mg | Drug | CL-108 5 mg |
| NorcoAlso: hydrocodone bitartrate/ acetaminophenhydrocodone 5 mg/APAP 325 mg | Drug | Norco |
| PlaceboAlso: Matching PlaceboPlacebo matching CL-108 | Drug | Placebo |
Primary outcome
Percentage of Participants With OINV Over 48 Hours
Time frame: Up to 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
The Sum of Pain Intensity Differences (on PI-NRS) Over 48 Hours (SPID48)
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 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".
7 secondary outcomes
Percentage of Patients With Complete Absence of OINV (no Nausea, no Vomiting, and no Use of Anti-emetic Medication) Over 48 Hours
Time frame: Up to 48 hours
Percentage of Patients With Any Vomiting Over 48 Hours
Time frame: Up to 48 hours
Percentage of Patients With Any Nausea Over 48 Hours
Time frame: Up to 48 hours
Percentage of Patients With Any Nausea or Vomiting Over 48 Hours
Time frame: Up to 48 hours
Percentage of Patients With Any Post-discharge Nausea and Vomiting (PDNV)
Time frame: Day 3 to 7
Number of Doses of Study Medication Taken Over Days 3to7
Time frame: Day3 to Day7
Number of Doses of Study Medication Taken Per Day Over Days 3to7
Time frame: Day3 to Day7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Charleston WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernard Schachtel, MD study director
Charleston Laboratories, Inc
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CL-108 5 mg and Norco in people with Pain and Nausea, run by Charleston Laboratories, Inc at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With OINV Over 48 Hours (time frame: Up to 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2023.