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HealthyEarly Phase 1NCT02221726

Study to Assess Adhesion Quality and Wear of Placebo JNJ-35685-AAA-G-023 Transdermal System in Healthy Adults

A Early Phase 1 study testing JNJ-35684-AAA-023: Size 1; small patch and JNJ-35684-AAA-023: Size 2; large patch in people with Healthy, run by Janssen Research & Development, LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
JNJ-35684-AAA-023: Size 1; small patch and JNJ-35684-AAA-023: Size 2; large patch
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteUnited States
Study dates
Aug 2014to Aug 2014
Phase
Early Phase 1
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 to 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Study site

    Cypress, California

Other trials in United States

About this study

Official title: 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).

Read the 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.

Conditions
Healthy
Being tested
JNJ-35684-AAA-023: Size 1; small patch, JNJ-35684-AAA-023: Size 2; large patch
Keywords
Healthy, JNJ-35685-AAA-G-023, Placebo, Transdermal delivery device system

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JNJ-35684-AAA-023: Size 1; small patchDrug

    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.

  • JNJ-35684-AAA-023: Size 2; large patchDrug

    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.

Study groups in NCT02221726
Study groupRoleWhat they receive
JNJ-35684-AAA-023: 5.5 cm^2 PatchExperimentalNot described
Receives: Drug: JNJ-35684-AAA-023: Size 1; small patch
JNJ-35684-AAA-023: 44 cm^2 PatchExperimentalNot described
Receives: Drug: JNJ-35684-AAA-023: Size 2; large patch

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual Grading United States Food and Drug Administration (FDA) Scale Score

    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).

    Measured: Baseline up to 72 hours following patch application

  2. Adhesion Area Calculated by Digital Image Analysis

    Digital image will be captured with high resolution for each transdermal patch site and adhesion area will be calculated.

    Measured: Baseline up to 72 hours following patch application

  3. Total Adhesion Score Calculated by Visual Grading Grid System

    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.

    Measured: Baseline up to 72 hours following patch application

Secondary outcomes (1)

  1. Number of Participants With Adverse Events (AEs) and Serious AEs

    Measured: Baseline up to 72 hours following patch application

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2014 (estimated)
  2. Study startAug 2014
  3. Primary completionAug 2014
  4. Study completionAug 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02221726
Sponsor's protocol ID
CR105188
Other IDs
FENPAI1024
Status last verified
Sep 2014
First submitted
19 Aug 2014
Last updated
15 Sep 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing JNJ-35684-AAA-023: Size 1; small patch and JNJ-35684-AAA-023: Size 2; large patch in people with Healthy, run by Janssen Research & Development, LLC 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 5 inclusion and 5 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 15 Sep 2014. 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. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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?

Visual Grading United States Food and Drug Administration (FDA) Scale Score (time frame: Baseline up to 72 hours following patch application). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02221726.

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 15 Sep 2014.

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