Expired Study
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Cypress, California


Purpose:

The purpose of this study is to evaluate the cumulative adhesion percentage for the test products and the reference products for both small and large patches.


Study summary:

This is a randomized (study medication assigned to participants by chance), single-center, parallel-group single-application, modified 3-way crossover study. Each participant will receive the marketed reference formulation (DURAGESIC) or the JNJ-35685-AAA-G016 or JNJ-35685-AAA-G021 fentanyl transdermal system (TDS). The study consists of a screening phase within 21 and 2 days before the first TDS application of the first period; a partially-blinded treatment phase consisting of 3 single-application treatment periods; and end-of-study or withdrawal assessments done upon completion of the 72-hour adhesion assessment on Day 5 of Period 3 or upon withdrawal. A 7- to 16-day washout period will separate the treatment periods, commencing at transdermal patch removal. The duration of participation in the study for an individual participant will be 31 days to a maximum of 68 days (including screening and follow-up visits). Participants will be primarily evaluated for cumulative adhesion percentage. Participants' safety will be monitored throughout the study.


Criteria:

Inclusion Criteria: - Participant must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. This determination must be recorded in the participant's source documents and initialed by the investigator - A woman of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) test at screening and urine pregnancy test at Day -1 of the first treatment period - A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control example, either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men must also not donate sperm during the study and for 3 months after completion of the study - Participant must be willing and able to adhere to the prohibitions and restrictions specified in this protocol - Body mass index (BMI) between 18 and 30 kilogram per square meter (kg/m^2), inclusive, and a body weight of not less than 50 kg Exclusion Criteria: - Participant has a 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 participant 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. Participants must not use tobacco products, including all nicotine use, example, cigarettes, cigars, chewing tobacco, patch, gum


Study is Available At:


Original ID:

CR108060


NCT ID:

NCT02608320


Secondary ID:

FENPAI1025


Study Acronym:


Brief Title:

A Study to Evaluate the Adherence of 2 Strengths of Newly Manufactured Samples and Aged Samples of a New Formulation (JNJ-35685-AAA-G016 and JNJ-35685


Official Title:

A Randomized, Partially-blinded, Two-arm, Single-application, 3-way Crossover Study to Evaluate the Adherence of 2 Strengths of Newly Manufactured Samples and Aged Samples of a New Formulation (JNJ-35685-AAA-G016 and JNJ-35685-AAA-G021) of Fentanyl Transd


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Janssen Research & Development, LLC


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

24


Number of Groups:

0


Total Enrollment:

52


Enrollment Type:

Actual


Overall Contact Information

Official Name:Janssen Research & Development, LLC Clinical Trial
Study Director
Janssen Research & Development, LLC

Study Dates

Start Date:November 17, 2015
Completion Date:April 13, 2016
Completion Type:Actual
Primary Completion Date:April 13, 2016
Primary Completion Type:Actual
Verification Date:June 2017
Last Changed Date:June 29, 2017
First Received Date:November 17, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Cumulative Adhesion Percentage
Time Frame:Time of patch application up to patch removal (up to 72 hours)
Safety Issues:False
Description:The actual percentages of patch adhesion will be estimated according to the Food and Drug Administration (FDA) 0-4 scoring system. An estimated percentage of adhesion, to a whole integer, will be obtained (FDA 0-4 [%] scoring) where 0=greater than or equa
Outcome Type:Secondary Outcome
Measure:Time to First Unacceptable Score
Time Frame:12, 24, 36, 48, 60, and 72 hour following patch application
Safety Issues:False
Description:Time to first unacceptable score that is < 75% adhered will be assessed.

Study Interventions

Intervention Type:Drug
Name:Duragesic (Fentanyl Transdermal System [TDS] Small
Description:Duragesic 12.5 mcg/h (Treatment A) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
Arm Name:Treatment Sequence (ACB) Position (RLR)
Intervention Type:Drug
Name:New JNJ-35685-AAA-G016 (Fentanyl TDS -Small Patche
Description:New JNJ-35685-AAA-G016 12.5 mcg/h (Treatment B) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
Arm Name:Treatment Sequence (ACB) Position (RLR)
Intervention Type:Drug
Name:Aged JNJ-35685-AAA-G016 (Fentanyl TDS Small Patche
Description:Aged JNJ-35685-AAA-G016 12.5 mcg/h (Treatment C) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
Arm Name:Treatment Sequence (ACB) Position (RLR)
Intervention Type:Drug
Name:Duragesic (Fentanyl TDS Large Patches)
Description:Duragesic 100 mcg/h (Treatment D) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours, applied to the paraspinal region of the back for 72 hours.
Arm Name:Treatment Sequence (DFE) Position (RLR)
Intervention Type:Drug
Name:New JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches
Description:New JNJ-35685-AAA-G021 100 mcg/h (Treatment E) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
Arm Name:Treatment Sequence (DFE) Position (RLR)
Intervention Type:Drug
Name:Aged JNJ-35685-AAA-G021 (Fentanyl TDS Large Patche
Description:Aged JNJ-35685-AAA-G021 100 mcg/h (Treatment F) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
Arm Name:Treatment Sequence (DFE) Position (RLR)

Study Arms

Study Arm Type:Experimental
Arm Name:Treatment Sequence (ACB) Position (RLR)
Description:Participants will receive treatment A (Duragesic 12.5 microgram per hour [mcg/h]) applied to right paraspinal side in period 1, then treatment C (aged JNJ- 35685-AAA-G016 12.5 mcg/h) applied to left paraspinal side in period 2 and then treatment B (New JNJ-35685- AAA-G016 12.5 mcg/h) applied to right paraspinal side in period 3.
Study Arm Type:Experimental
Arm Name:Treatment Sequence (BAC) Position (RLR)
Description:Participants will receive treatment B applied to right paraspinal side in period 1, then treatment A applied to left paraspinal side in period 2 and then treatment C applied to right paraspinal side in period 3.
Study Arm Type:Experimental
Arm Name:Treatment Sequence (CBA) Position (RLR)
Description:Participants will receive treatment C applied to right paraspinal side in period 1, then treatment B applied to left paraspinal side in period 2 and then treatment A applied to right paraspinal side in period 3.
Study Arm Type:Experimental
Arm Name:Treatment Sequence (BCA) Position (RLR)
Description:Participants will receive treatment B applied to right paraspinal side in period 1, then treatment C applied to left paraspinal side in period 2 and then treatment A applied to right paraspinal side in period 3.
Study Arm Type:Experimental
Arm Name:Treatment Sequence (CAB) Position (RLR)
Description:Participants will receive treatment C applied to right paraspinal side in period 1, then treatment A applied to left paraspinal side in period 2 and then treatment B applied to right paraspinal side in period 3.
Study Arm Type:Experimental
Arm Name:Treatment Sequence (ABC) Position (RLR)
Description:Participants will receive treatment A applied to right paraspinal side in period 1, then treatment B applied to left paraspinal side in period 2 and then treatment C applied to right paraspinal side in period 3.
Study Arm Type:Experimental
Arm Name:Treatment Sequence (ACB) Position (LRL)
Description:Participants will receive treatment A applied to left paraspinal side in period 1, then treatment C applied to right paraspinal side in period 2 and then treatment B applied to left paraspinal side in period 3.
Study Arm Type:Experimental
Arm Name:Treatment Sequence (BAC) Position (LRL)
Description:Participants will receive treatment B applied to left paraspinal side in period 1, then treatment A applied to right paraspinal side in period 2 and then treatment C applied to left paraspinal side in period 3.
Study Arm Type:Experimental
Arm Name:Treatment Sequence (CBA) Position (LRL)
Description:Participants will receive treatment C applied to left paraspinal side in period 1, then treatment B applied to right paraspinal side in period 2 and then treatment A applied to left paraspinal side in period 3.
Study Arm Type:Experimental
Arm Name:Treatment Sequence (BCA) Position (LRL)
Description:Participants will receive treatment B applied to left paraspinal side in period 1, then treatment C applied to right paraspinal side in period 2 and then treatment A applied to left paraspinal side in period 3.
Study Arm Type:Experimental
Arm Name:Treatment Sequence (CAB) Position (LRL)
Description:Participants will receive treatment C applied to left paraspinal side in period 1, then treatment A applied to right paraspinal side in period 2 and then treatment B applied to left paraspinal side in period 3.
Study Arm Type:Experimental
Arm Name:Treatment Sequence (ABC) Position (LRL)
Description:Participants will receive treatment A applied to left paraspinal side in period 1, then treatment B applied to right paraspinal side in period 2 and then treatment C applied to left paraspinal side in period 3.
Study Arm Type:Experimental
Arm Name:Treatment Sequence (DFE) Position (RLR)
Description:Participants will receive treatment D (Duragesic 100 mcg/h) applied to right paraspinal side in period 1, then treatment F (aged JNJ-35685-AAA-G021 100 mcg/h) applied to left paraspinal side in period 2 and then treatment E (new JNJ-35685-AAA-G021 100 mcg/h) applied to right paraspinal side in period 3.
Study Arm Type:Experimental
Arm Name:Treatment Sequence (EDF) Position (RLR)
Description:Participants will receive treatment E applied to right paraspinal side in period 1, then treatment D applied to left paraspinal side in period 2 and then treatment F applied to right paraspinal side in period 3.
Study Arm Type:Experimental
Arm Name:Treatment Sequence (FED) Position (RLR)
Description:Participants will receive treatment F applied to right paraspinal side in period 1, then treatment E applied to left paraspinal side in period 2 and then treatment D applied to right paraspinal side in period 3.
Study Arm Type:Experimental
Arm Name:Treatment Sequence (EFD) Position (RLR)
Description:Participants will receive treatment E applied to right paraspinal side in period 1, then treatment F applied to left paraspinal side in period 2 and then treatment D applied to right paraspinal side in period 3.
Study Arm Type:Experimental
Arm Name:Treatment Sequence (FDE) Position (RLR)
Description:Participants will receive treatment F applied to right paraspinal side in period 1, then treatment D applied to left paraspinal side in period 2 and then treatment E applied to right paraspinal side in period 3.
Study Arm Type:Experimental
Arm Name:Treatment Sequence (DEF) Position (RLR)
Description:Participants will receive treatment D applied to right paraspinal side in period 1, then treatment E applied to left paraspinal side in period 2 and then treatment F applied to right paraspinal side in period 3.
Study Arm Type:Experimental
Arm Name:Treatment Sequence (DFE) Position (LRL)
Description:Participants will receive treatment D applied to left paraspinal side in period 1, then treatment F applied to right paraspinal side in period 2 and then treatment E applied to left paraspinal side in period 3.
Study Arm Type:Experimental
Arm Name:Treatment Sequence (EDF) Position (LRL)
Description:Participants will receive treatment E applied to left paraspinal side in period 1, then treatment D applied to right paraspinal side in period 2 and then treatment F applied to left paraspinal side in period 3.
Study Arm Type:Experimental
Arm Name:Treatment Sequence (FED) Position (LRL)
Description:Participants will receive treatment F applied to left paraspinal side in period 1, then treatment E applied to right paraspinal side in period 2 and then treatment D applied to left paraspinal side in period 3.
Study Arm Type:Experimental
Arm Name:Treatment Sequence (EFD) Position (LRL)
Description:Participants will receive treatment E applied to left paraspinal side in period 1, then treatment F applied to right paraspinal side in period 2 and then treatment D applied to left paraspinal side in period 3.
Study Arm Type:Experimental
Arm Name:Treatment Sequence (FDE) Position (LRL)
Description:Participants will receive treatment F applied to left paraspinal side in period 1, then treatment D applied to right paraspinal side in period 2 and then treatment E applied to left paraspinal side in period 3.
Study Arm Type:Experimental
Arm Name:Treatment Sequence (DEF) Position (LRL)
Description:Participants will receive treatment D applied to left paraspinal side in period 1, then treatment E applied to right paraspinal side in period 2 and then treatment F applied to left paraspinal side in period 3.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Janssen Research & Development, LLC

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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