PainPhase 3NCT01780428
Phase III Study of the Safety and Efficacy of Cl-108 in the Treatment of Moderate to Severe Pain
A Phase 3 study testing CL-108 (hydrodocone 7.5 mg, acetaminophen 325 mg, promethazine 12.5 mg) in people with Pain and Nausea, run by Charleston Laboratories, Inc at 1 site in United States.
Trial summary
This is a double-blind, randomized, multiple-dose, placebo- and positive-controlled study of CL-108 (hydrocodone 7.5 mg/APAP 325 mg, promethazine 12.5 mg) in patients with moderate to severe pain following surgical removal of impacted third molar teeth. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- CL-108 (hydrodocone 7.5 mg, acetaminophen 325 mg, promethazine 12.5 mg)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 460 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Dec 2014
- 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
- Determination of being likely or possibly nausea-prone.
- Male or non-pregnant and non-lactating female.
- Surgical extraction of at least 2 impacted third molar teeth
- 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.
- Surgical extraction of at least 2 impacted third molar teeth.
- Presence of at least moderate post-operative pain.
Who cannot join
- Medial Condition, presence of a serious medical condition.
- Active local infection.
- Drug Allergy history of hypersensitivity to an Opioid, Promethazine, Acetaminophen.
- Caffeine use since midnight before the operation.
- Use of an IND Drug within past 30 days.
- Previous participation in this study.
- Pregnant or lactating.
- Employee of the PI,sub-investigator or Charleston Labs or relative of an employee.
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, Placebo-Controlled, Multiple-dose Multi-Center Phase III Study of the Safety and Efficacy of Cl-108 in the Treatment of Moderate to Severe Pain
This is a double-blind, randomized, multiple-dose, placebo- and positive-controlled study of CL-108 (hydrocodone 7.5 mg/APAP 325 mg, promethazine 12.5 mg) in patients with moderate to severe pain following surgical removal of impacted third molar teeth.
A positive control ( Norco, a commercial formulation of hydrocodone 7.5 mg/APAP 325 mg) was included to determine the anti-emetic effects of CL-108. The efficacy of CL-108 was also evaluated to placebo for the relief of pain.
- Being tested
- CL-108 (hydrodocone 7.5 mg, acetaminophen 325 mg, promethazine 12.5 mg), 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 (hydrodocone 7.5 mg, acetaminophen 325 mg, promethazine 12.5 mg)Drug
Also called Norco (hydrocodone 7.5 mg, acetaminophen 325 mg), Placebo
PlaceboDrug
| 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 (hydrodocone 7.5 mg, acetaminophen 325 mg, promethazine 12.5 mg) |
| Norco | Active comparator | Commercial product containing hydrocodone 7.5 mg. acetaminophen 325 mg Receives: Drug: CL-108 (hydrodocone 7.5 mg, acetaminophen 325 mg, promethazine 12.5 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.
To compare the occurrence and severity of opioid-induced nausea and vomiting (OINV) associated with CL-108 to Norco.
After data has been locked.
Measured: Over the first 24 hours
To demonstrate the efficacy of CL-108 when compared to placebo for the relief of pain following surgical removal of impacted third molar teeth.
After data has been locked.
Measured: over 24 hours (SPID24)
Secondary outcomes (2)
Reduction of the severity of nausea in patients treated with an opioid-containing pain reliever.
After data lock.
Measured: over 6 hours
Reduction of vomiting in patients treated with an opioid-containing pain reliever.
After data lock.
Measured: over 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionOct 2013
- Study completionDec 2014
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charleston Laboratories, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01780428
- Sponsor's protocol ID
- CLCT-002
- Status last verified
- Nov 2016
- First submitted
- 28 Jan 2013
- Last updated
- 3 Nov 2016
- Results posted
- 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, Placebo-Controlled, Multiple-dose Multi-Center Phase III Study of the Safety and Efficacy of Cl-108 in the Treatment of Moderate to Severe Pain
- ClinicalTrials.gov ID
- NCT01780428
- Acronym / sponsor ID
- CLCT-002
- Keywords
- Pain, Nausea, Vomiting
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 460 participants (actual)
- Lead sponsor
- Charleston Laboratories, IncIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 31 Jan 2013 (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.
This is a double-blind, randomized, multiple-dose, placebo- and positive-controlled study of CL-108 (hydrocodone 7.5 mg/APAP 325 mg, promethazine 12.5 mg) in patients with moderate to severe pain following surgical removal of impacted third molar teeth.
A positive control ( Norco, a commercial formulation of hydrocodone 7.5 mg/APAP 325 mg) was included to determine the anti-emetic effects of CL-108. The efficacy of CL-108 was also evaluated to placebo for the relief of pain.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CL-108 | Experimental | Drug: CL-108 (hydrodocone 7.5 mg, acetaminophen 325 mg, promethazine 12.5 mg)CL-108 (hydrocodone 7.5 mg, acetaminophen 325 mg, Promethazine 12.5 mg) |
| Norco | Active comparator | Drug: CL-108 (hydrodocone 7.5 mg, acetaminophen 325 mg, promethazine 12.5 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 (6 listed)
- Determination of being likely or possibly nausea-prone.
- Male or non-pregnant and non-lactating female.
- Surgical extraction of at least 2 impacted third molar teeth
- 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.
- Surgical extraction of at least 2 impacted third molar teeth.
Key exclusion criteria (8 listed)
- Medial Condition, presence of a serious medical condition.
- Active local infection.
- Drug Allergy history of hypersensitivity to an Opioid, Promethazine, Acetaminophen.
- Caffeine use since midnight before the operation.
- Use of an IND Drug within 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 (hydrodocone 7.5 mg, acetaminophen 325 mg, promethazine 12.5 mg)Also: Norco (hydrocodone 7.5 mg, acetaminophen 325 mg), Placebo | Drug | CL-108, Norco |
| Placebo | Drug | Placebo |
Primary outcome
To compare the occurrence and severity of opioid-induced nausea and vomiting (OINV) associated with CL-108 to Norco.
Time frame: Over the first 24 hours
After data has been locked.
To demonstrate the efficacy of CL-108 when compared to placebo for the relief of pain following surgical removal of impacted third molar teeth.
Time frame: over 24 hours (SPID24)
After data has been locked.
2 secondary outcomes
Reduction of the severity of nausea in patients treated with an opioid-containing pain reliever.
Time frame: over 6 hours
Reduction of vomiting in patients treated with an opioid-containing pain reliever.
Time frame: over 6 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 (hydrodocone 7.5 mg, acetaminophen 325 mg, promethazine 12.5 mg) in people with Pain and Nausea, run by Charleston Laboratories, Inc 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 6 inclusion and 8 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?
To compare the occurrence and severity of opioid-induced nausea and vomiting (OINV) associated with CL-108 to Norco. (time frame: Over the first 24 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.