- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02221726
Study to Assess Adhesion Quality and Wear of Placebo JNJ-35685-AAA-G-023 Transdermal System in Healthy Adults
September 12, 2014 updated by: Janssen Research & Development, LLC
Evaluation of Scoring Methods to Assess Adhesion Quality and Wear of the Placebo JNJ-35685-AAA-G-023 5.5 cm^2 and 44 cm^2 Transdermal Systems
The purpose of this study is to assess 3 different scoring systems to evaluate the adhesive quality of placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial]) JNJ-35685-AAA-G-023-G transdermal (through the skin) systems during a single system 72-hour application, replicated 3 times, of 2 patch sizes (5.5 centimeter^2 [cm^2] and 44 cm^2).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study will assess 3 different scoring systems to evaluate the adhesive quality of "placebo" patch (an inactive patch that contains no active drug), JNJ-35685-AAA-G-023-G transdermal (through the skin) system.
In this study, this patch is NOT being compared to a patch with a drug, and is NOT being used to test if the patch with the drug has a real effect in a clinical trial.
The study consists 3 parts: Screening (21 days before study commences on Day 1), an adhesion assessment period (4 days), and an end of Study (EOS) assessment (recorded at 24 hours +/- 4 hours following patch removal).
Total study duration per participant will be 26 days (including Screening).
JNJ-35685-AAA-G-023 small (5.5 cm^2) and large (44 cm^2) patches will be applied on to left or right side of the paraspinal region based on randomization schedule.
Adhesion assessments will be performed at patch application (hour 0, Baseline), and during the time interval of 8 to 10 hours, 24, 48, and 72 hours following patch application.
Adhesion quality will be assessed by visual grading, United States Food and Drug Administration (FDA) scale, digital image analysis and visual grading grid system.
Participants' safety will be monitored throughout the study.
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Cypress, California, United States
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Body mass index (BMI: weight in kilogram [kg]/height^2 [meter (m^2)]) between 18 and 35 kg/m^2 (inclusive), and body weight not less than 50 kg
- Blood pressure (can be taken in supine or sitting position) between 90 and 140 milimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic
- Non-smoker (for at least 6 months prior to screening) and willing to abstain from smoking during the study confinement period
- Good general health as determined by medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests
- Willing to adhere to the prohibitions and restrictions specified in this protocol
Exclusion Criteria:
- History of or current clinically significant medical illness including but not limited to, cardiac arrhythmias or other cardiac disease; hematologic disease; coagulation disorders (including any abnormal bleeding or blood dyscrasias); lipid abnormalities; significant pulmonary disease, including bronchospastic respiratory disease; diabetes mellitus; hepatic or renal insufficiency (creatinine clearance below 60 milliliter per minute [mL/min]); thyroid disease; neurologic or psychiatric disease; infection; or any other illness that the Investigator considers should exclude the subject or that could interfere with the interpretation of the study results
- Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening as deemed appropriate by the Investigator
- Clinically significant abnormal physical examination, vital signs or 12 lead ECG at screening as deemed appropriate by the Investigator
- Use of medications or treatments that would significantly influence or exaggerate patch adhesion or that would alter inflammatory or immune response to the study product (example, antihistamines, systemic or topical corticosteroids, cyclosporine, tacrolimus, cytotoxic drugs, immune globulin, Bacillus Calmette-Guerin (BCG), monoclonal antibodies, radiation therapy)
- History of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (4th edition) criteria within 5 years before screening or positive test result(s) for alcohol and/or drugs of abuse (such as barbiturates, opiates, cocaine, cannabinoids, amphetamines, and benzodiazepines) at screening
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: JNJ-35684-AAA-023: 5.5 cm^2 Patch
|
Placebo (matched to Fentanyl transdermal delivery device system [TDDS]) JNJ-35685-AAA-G-023 TDDS, 5.5 centimeter square (cm^2) will be applied vertically to 1 side of the paraspinal region, replicated 3 times, and worn for 72 hours.
|
Experimental: JNJ-35684-AAA-023: 44 cm^2 Patch
|
Placebo (matched to Fentanyl transdermal delivery device system [TDDS]) JNJ-35685-AAA-G-023 TDDS, 44 cm^2 (Size 1; small patch) will be applied vertically to other side of the paraspinal region, replicated 3 times, and worn for 72 hours.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Grading United States Food and Drug Administration (FDA) Scale Score
Time Frame: Baseline up to 72 hours following patch application
|
Visual grading US FDA scale will be used to evaluate adhesion performance of the transdermal system.
The score ranges from 0-4: 0 = greater than or equal to (>=) 90 percent (%) adhered (essentially no lift off the skin); 1 = greater than or equal to 75% to less than (<) 90% adhered (some edges only lifting off the skin); 2 = greater than or equal to 50% to <75% adhered (less than half of the patch lifting off the skin); 3 = greater than (>) 0% to <50% adhered but not detached (more than half of the patch lifting off the skin without falling off); and 4 = 0% adhered - patch detached (patch completely off the skin).
|
Baseline up to 72 hours following patch application
|
Adhesion Area Calculated by Digital Image Analysis
Time Frame: Baseline up to 72 hours following patch application
|
Digital image will be captured with high resolution for each transdermal patch site and adhesion area will be calculated.
|
Baseline up to 72 hours following patch application
|
Total Adhesion Score Calculated by Visual Grading Grid System
Time Frame: Baseline up to 72 hours following patch application
|
Total adhesion score will be calculated by visual grading grid system (a grid system based on 20 four-sided divisions that are approximately 5% of the total patch area; 44 cm^2 patch will be evaluated by square and rectangular grid elements while 5.5 cm^2 patch will be evaluated by square grid element only) which also contains a scale to allow for proper determination of actual area of the patch not adhering to the skin.
Total area of the patch which does not adhere will be calculated.
Any area of the patch that does not entirely adhere onto the skin will be scored as 0% adhesion for that area.
Subsequently, a total adhesion score for that system will be calculated.
|
Baseline up to 72 hours following patch application
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Participants With Adverse Events (AEs) and Serious AEs
Time Frame: Baseline up to 72 hours following patch application
|
Baseline up to 72 hours following patch application
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2014
Primary Completion (Actual)
August 1, 2014
Study Completion (Actual)
August 1, 2014
Study Registration Dates
First Submitted
August 19, 2014
First Submitted That Met QC Criteria
August 19, 2014
First Posted (Estimate)
August 20, 2014
Study Record Updates
Last Update Posted (Estimate)
September 15, 2014
Last Update Submitted That Met QC Criteria
September 12, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR105188
- FENPAI1024 (Other Identifier: Janssen Research & Development, LLC)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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