PainPhase 3NCT02462811
A Double-Blind, Randomized, Active- and Placebo-Controlled, Multiple-Dose Multi-Center Phase 3 Study of the Safety and Efficacy of CL-108 in the Treatment of Moderate to Severe Acute Pain and Opioid-Induced Nausea and Vomiting (OINV)
A Phase 3 study testing CL-108 (hydrocodone 7.5 mg, acetaminophen 325 mg, promethazine 12.5 mg) and Norco (hyrdocodone 7,5 mg, acetaminophen 325 mg) in people with Pain and Nausea, run by Joseph Hazelton at 1 site in United States.
Trial summary
The objectives of this study are to compare the occurrence and severity of opioid-induced nausea and vomiting (OINV) associated with CL-108 to Norco®, and to demonstrate the efficacy of CL-108 when compared to placebo for the relief of moderate to severe pain In patients with moderate to severe pain following… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- CL-108 (hydrocodone 7.5 mg, acetaminophen 325 mg, promethazine 12.5 mg) and Norco (hyrdocodone 7,5 mg, acetaminophen 325 mg)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 552 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Aug 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 consent obtained at screening prior to any procedures being performed.
- Gender: Male or non-pregnant and non-lactating female. A female of child-bearing potential is eligible to participate in this study if she has a negative urine pregnancy test and is using an acceptable method of birth control (i.e., oral, transdermal, or implanted contraceptives, intrauterine device, diaphragm, condom, abstinence, or surgical sterilization)
- Age: 18 years or older
- OINV Status: At risk of OINV on the Nausea Prone Questionnaire (NPQ)
- Foot Condition: Surgical extraction of a unilateral first metatarsal bunion confirmed by foot x-ray (assessed by surgeon prior to surgery)
- Pain Severity: Presence of moderate or severe pain (i.e., ≥ 4 on the baseline numerical pain intensity rating scale [PI-NRS])
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- Pain Confirm: Rating ≥ 50 mm on the baseline visual analog pain intensity scale (PI-VAS)
- Diary Completion: Be willing and able to record safety and efficacy information in the In-patient and Outpatient Diaries
- Safe Transportation: Patient must have arrangements for transportation home from the research center accompanied by a responsible adult
- EXLUSION CRITERIA
- Medical Condition: Presence of a serious medical condition (e.g., poorly controlled hypertension or diabetes, neurological disease including Parkinson's or other condition associated with a movement disorder, significantly impaired cardiac, renal, hepatic, respiratory, or thyroid function)
- Infection: Acute local infection at the time of surgery that could confound post-surgical evaluation.
- Drug Allergy: History of hypersensitivity or allergy to an opioid drug such as hydrocodone, promethazine, acetaminophen, ondansetron, NSAID (such as ibuprofen, including aspirin) or ketorolac or history of a dystonic/dyskinetic reaction to prior anti-emetic or anti-psychotic medication
- Contraindicated Drugs: Use (within 24 hours of the surgical procedure) of any confounding prescription or non-prescription drug (e.g., analgesic, anti-emetic, sedating antihistamine, sedative, alcohol, CNS/psychotropic agent, including sleep aides, benzodiazepines, performance/attention enhancers, marijuana, anti-depressants) or any drug contraindicated with hydrocodone, acetaminophen, or promethazine (except for pre-op medications). Antibiotic prophylaxis for endocarditis (except if known to cause nausea) and ASA 62.5 mg for cardiovascular prophylaxis are permitted during the study.
- History of drug or alcohol abuse
- Caffeine Use: Ingestion of any caffeine-containing beverage or chocolate since mid-night before the operation
- Investigation 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
- Participant Relation: Employee at the research center or of Charleston Laboratories or relative of the Principal Investigator, Sub-Investigators, or research staff who is directly involved in this study
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104-6030
About this study
Official title: A Double-Blind, Randomized, Active- and Placebo-Controlled, Multiple-Dose, Multi-Center Phase 3 Study of the Safety and Efficacy of CL-108 in the Treatment of Moderate to Severe Pain and Opioid-Induced Nausea and Vomiting (OINV)
The objectives of this study are to compare the occurrence and severity of opioid-induced nausea and vomiting (OINV) associated with CL-108 to Norco®, and to demonstrate the efficacy of CL-108 when compared to placebo for the relief of moderate to severe pain In patients with moderate to severe pain following bunionectomy (osteotomy with fixation of the head of the first metatarsal bone).
- Being tested
- CL-108 (hydrocodone 7.5 mg, acetaminophen 325 mg, promethazine 12.5 mg), Placebo, Norco (hyrdocodone 7,5 mg, acetaminophen 325 mg)
- 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 (hydrocodone 7.5 mg, acetaminophen 325 mg, promethazine 12.5 mg)Drug
PlaceboDrug
Norco (hyrdocodone 7,5 mg, acetaminophen 325 mg)Drug
| Study group | Role | What they receive |
|---|---|---|
| CL-108 | Experimental | CL-108 hydrocodone 7.5 mg, acetaminophen 325 mg, Promethazine 12.5 mg Receives: Drug: CL-108 (hydrocodone 7.5 mg, acetaminophen 325 mg, promethazine 12.5 mg) |
| Active Comparator: Norco | Active comparator | Commercial product containing hydrocodone 7.5 mg, acetaminophen 325 mg Receives: Drug: Norco (hyrdocodone 7,5 mg, acetaminophen 325 mg) |
| Placebo | Placebo comparator | CL-108 formulation without API Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence of opioid-induced nausea and vomiting (OINV) as assessed by an OINV questionnaire comparing CL-108 to Norco® over 48 hours.
Measured: 48 hours
The relief of moderate to severe pain, assessed by visual analog pain intensity scale, comparing CL-108 to placebo over 48 hours (SPID48).
Measured: 48 hours
Secondary outcomes (6)
The severity of opioid-induced nausea, comparing CL-108 to Norco® over 48 hours
Measured: 48 hours
The occurrence of vomiting, comparing CL-108 to Norco® over 48 hours
Measured: 48 hours
The use of anti-emetics, comparing CL-108 to Norco® over 48 hours.
Measured: 48 hours
Incidence of post-discharge nausea and vomiting (PDNV), comparing CL-108 to placebo over days 3-5
Measured: 48 hours
The relief of post-operative nausea and vomiting (PONV), comparing CL-108 to placebo over 48 hours
Measured: 48 hours
The relief of severe pain, comparing CL-108 to Norco® over 48 hours, i.e., summed pain intensity differences over 48 hours (SPID48)
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2015 (estimated)
- Study startSep 2014
- Primary completionJul 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 552 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joseph Hazelton
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Joseph Hazelton, Charleston Laboratories, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02462811
- Sponsor's protocol ID
- CLCL-003
- Status last verified
- Jan 2016
- First submitted
- 22 May 2015
- Last updated
- 3 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Active- and Placebo-Controlled, Multiple-Dose, Multi-Center Phase 3 Study of the Safety and Efficacy of CL-108 in the Treatment of Moderate to Severe Pain and Opioid-Induced Nausea and Vomiting (OINV)
- ClinicalTrials.gov ID
- NCT02462811
- Acronym / sponsor ID
- CLCL-003
- Keywords
- Pain, Nausea, Vomiting
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 552 participants (actual)
- Lead sponsor
- Joseph HazeltonIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 4 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this study are to compare the occurrence and severity of opioid-induced nausea and vomiting (OINV) associated with CL-108 to Norco®, and to demonstrate the efficacy of CL-108 when compared to placebo for the relief of moderate to severe pain In patients with moderate to severe pain following bunionectomy (osteotomy with fixation of the head of the first metatarsal bone).
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 | Experimental | Drug: CL-108 (hydrocodone 7.5 mg, acetaminophen 325 mg, promethazine 12.5 mg)CL-108 hydrocodone 7.5 mg, acetaminophen 325 mg, Promethazine 12.5 mg |
| Active Comparator: Norco | Active comparator | Drug: Norco (hyrdocodone 7,5 mg, acetaminophen 325 mg)Commercial product containing hydrocodone 7.5 mg, acetaminophen 325 mg |
| Placebo | Placebo comparator | Drug: PlaceboCL-108 formulation without API |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Informed Consent: Signed consent obtained at screening prior to any procedures being performed.
- Gender: Male or non-pregnant and non-lactating female. A female of child-bearing potential is eligible to participate in this study if she has a negative urine pregnancy test and is using an acceptable method of birth control (i.e., oral, transdermal, or implanted contraceptives, intrauterine device, diaphragm, condom, abstinence, or surgical sterilization)
- Age: 18 years or older
- OINV Status: At risk of OINV on the Nausea Prone Questionnaire (NPQ)
- Foot Condition: Surgical extraction of a unilateral first metatarsal bunion confirmed by foot x-ray (assessed by surgeon prior to surgery)
Key exclusion criteria (0 listed)
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 (hydrocodone 7.5 mg, acetaminophen 325 mg, promethazine 12.5 mg) | Drug | CL-108 |
| Placebo | Drug | Placebo |
| Norco (hyrdocodone 7,5 mg, acetaminophen 325 mg) | Drug | Active Comparator: Norco |
Primary outcome
The occurrence of opioid-induced nausea and vomiting (OINV) as assessed by an OINV questionnaire comparing CL-108 to Norco® over 48 hours.
Time frame: 48 hours
The relief of moderate to severe pain, assessed by visual analog pain intensity scale, comparing CL-108 to placebo over 48 hours (SPID48).
Time frame: 48 hours
6 secondary outcomes
The severity of opioid-induced nausea, comparing CL-108 to Norco® over 48 hours
Time frame: 48 hours
The occurrence of vomiting, comparing CL-108 to Norco® over 48 hours
Time frame: 48 hours
The use of anti-emetics, comparing CL-108 to Norco® over 48 hours.
Time frame: 48 hours
Incidence of post-discharge nausea and vomiting (PDNV), comparing CL-108 to placebo over days 3-5
Time frame: 48 hours
The relief of post-operative nausea and vomiting (PONV), comparing CL-108 to placebo over 48 hours
Time frame: 48 hours
The relief of severe pain, comparing CL-108 to Norco® over 48 hours, i.e., summed pain intensity differences over 48 hours (SPID48)
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2016.
- Charleston WebsiteLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 (hydrocodone 7.5 mg, acetaminophen 325 mg, promethazine 12.5 mg) and Norco (hyrdocodone 7,5 mg, acetaminophen 325 mg) in people with Pain and Nausea, run by Joseph Hazelton at 1 site 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 20 inclusion and 0 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 3 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The occurrence of opioid-induced nausea and vomiting (OINV) as assessed by an OINV questionnaire comparing CL-108 to Norco® over 48 hours. (time frame: 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 3 Nov 2016.