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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: JNJ-35684-AAA-023: 5.5 cm^2 Patch
Drug: JNJ-35684-AAA-023: Size 1; small 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
Drug: JNJ-35684-AAA-023: Size 2; large 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Research & Development, LLC

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 19, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 20, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 15, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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