Pilot Study Comparing the Efficacy and Safety of a New Pain Patch and Placebo in Delayed Onset Muscle Soreness (DOMS)
NCT ID: NCT02602353
Last Updated: 2016-10-28
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
PHASE2
42 participants
INTERVENTIONAL
2015-10-31
2015-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Loxoprofen Pain Patch
One Active Pain Patch containing loxoprofen applied once daily for 3 days
Loxoprofen Pain Patch
One Loxoprofen Pain Patch (active NSAID) applied once daily for 3 days
Placebo Patch
One Placebo Patch applied once daily for 3 days
Placebo Patch
One Placebo Patch applied daily for 3 days
No Treatment
No Treatment for 3 days
No Treatment
No Treatment for 3 days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Loxoprofen Pain Patch
One Loxoprofen Pain Patch (active NSAID) applied once daily for 3 days
Placebo Patch
One Placebo Patch applied daily for 3 days
No Treatment
No Treatment for 3 days
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* are in good general health, with a BMI less than or equal to 32, and able to perform the exercise regimen
* develops muscle pain/soreness within 24-48 hours of the end of the exercise regimen and have a baseline muscle pain/soreness with movement of greater than or equal to 5 on the Numerical Rating Scale (NRS) (numerical rating scale) and at least "moderate" on the categorical scale
Exclusion Criteria
* has been working heavy manual or physical labor jobs within 3 months prior to study participation.
* has a known history of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, or any nonsteroidal anti-inflammatory drugs
* has skin lesions such as psoriasis at the application site
* has abnormal skin condition such as eczema, contact dermatitis, pigment anomaly, etc.
* has an allergy-related skin condition
18 Years
40 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cardinal Health
INDUSTRY
Lead Chemical Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Derek Muse, MD
Role: PRINCIPAL_INVESTIGATOR
Jean Brown Research
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Jean Brown Research
Salt Lake City, Utah, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
LEAD-PhII-050
Identifier Type: -
Identifier Source: org_study_id