Phase III Study of the Safety and Efficacy of Cl-108 in the Treatment of Moderate to Severe Pain
NCT ID: NCT01780428
Last Updated: 2016-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
460 participants
INTERVENTIONAL
2013-01-31
2014-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
PREVENTION
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CL-108
CL-108 (hydrocodone 7.5 mg, acetaminophen 325 mg, Promethazine 12.5 mg)
CL-108 (hydrodocone 7.5 mg, acetaminophen 325 mg, promethazine 12.5 mg)
Norco
Commercial product containing hydrocodone 7.5 mg. acetaminophen 325 mg
CL-108 (hydrodocone 7.5 mg, acetaminophen 325 mg, promethazine 12.5 mg)
Placebo
CL-108 formulation without API
Placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CL-108 (hydrodocone 7.5 mg, acetaminophen 325 mg, promethazine 12.5 mg)
Placebo
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Charleston Laboratories, Inc
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Charleston Website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CLCT-002
Identifier Type: -
Identifier Source: org_study_id