Peer Review, ResearchPhase 4NCT02486016
Transdermal Patch CVD 2000: The Effect of Heat on Fentanyl Release From Fentanyl TDSs in Healthy Adults
A Phase 4 study testing Duragesic reference fentanyl TDS, Apotex generic fentanyl TDS and Mylan generic fentanyl TDS in people with Peer Review, Research, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
This is an Open-label, Non-Randomized, 3-way Crossover Bioequivalence Study to compare fentanyl release after heating of a brand name (Duragesic) and generic (Apotex and Mylan) fentanyl (transdermal delivery system)TDSs in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Peer Review, Research
- What is being tested?
- Duragesic reference fentanyl TDS, Apotex generic fentanyl TDS and Mylan generic fentanyl TDS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2015to 9 Aug 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Men or non-pregnant women of any ethnic background between the age of 18 and 45 years old.
- 2. Subjects must be non-smokers (must have refrained from the use of nicotine-containing substances, including tobacco products (e.g., cigarettes, cigars, chewing tobacco, gum, patch or electronic cigarettes) over the previous 2 months and are not currently using tobacco products.
- 3. Provide written informed consent before initiation of any study procedures.
- 4. Available for follow-up for the planned duration of the study.
- 5. Able to communicate well with the investigators.
- 6. Able to adhere to the study protocol schedule.
Show all 17Show fewer
- 7. Subjects who are within their ideal body weight (BMI>17 and ≤ 28).
- 8. Demonstrate comprehension of the protocol procedures and knowledge of study by passing (>70% correct responses) a written examination containing 20 multiple choice and true false questions covering all aspects of the study including the purpose, procedures, risks and benefits.
- 9. Subjects deemed to be healthy as judged by the Medically Accountable Investigator (MAI) and determined by medical history, physical examination, and medication history.
- 10. Negative urine drug screening test.
- 11. Have a normal blood pressure (systolic: 90-140 mmHg; diastolic: 50-90 mmHg) and heart rate (55-100 bpm).
- 12. Have normal screening laboratories for WBC, Hgb, platelets, sodium, potassium, chloride, bicarbonate, BUN, creatinine, ALT, AST and total bilirubin.
- 13. Have normal screening laboratories for urine protein and urine glucose.
- 14. Female subjects must be of non-childbearing potential (as defined as surgically sterile [i.e. history of hysterectomy or tubal ligation] or postmenopausal for more than 1 year), or if of childbearing potential must be non-pregnant at the time of enrollment and on the morning of each procedure, and must agree to use hormonal or barrier birth control such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence, or a vasectomized partner.
- 15. Agrees not to participate in another clinical study during the study period.
- 16. Agrees not to donate blood to a blood bank throughout participation in the study and for at least 3 months after last procedure day.
- 17. Have a normal ECG.
Who cannot join
- 1. Women who are pregnant, lactating, breast feeding or have a positive serum pregnancy test at enrollment or on the morning of any procedure day.
- 2. Smokers (current use or use over the previous 2 months of nicotine-containing substances, including tobacco products (e.g., cigarettes, cigars, chewing tobacco, gum, patch or electronic cigarettes).
- 3. Participation in any ongoing investigational drug trial or clinical drug trial.
- 4. Abnormal Vital signs, defined as:
- Hypertension (systolic blood pressure >140 mm Hg or diastolic blood pressure >90 mm Hg) at rest on 2 separate days)
- Heart rate <55 at rest on 2 separate days
Show all 23Show fewer
- Respiratory rate >20
- 5. Temperature > 38.0°C (100.4°F) or symptoms of an acute self-limited illness such as an upper respiratory infection or gastroenteritis within 7 days of application of the fentanyl TDS.
- 6. History of chronic obstructive pulmonary disease.
- 7. Active positive Hepatitis B, C, and HIV serologies.
- 8. Positive urine drug screening test.
- 9. Use of any prescription medication during the period 0 to 30 days or over-the counter medication (vitamin, herbal supplements and birth control medications not included) during the period 0 to 3 days before entry to the study.
- 10. Donation or loss of greater than one pint of blood within 60 days of entry to the study.
- 11. Any prior serious adverse reaction or hypersensitivity to fentanyl, naltrexone or naloxone or any of the inactive ingredients in the TDS (alcohol, ethylene vinyl acetate-copolymer membrane and hydroxyethyl cellulose, polyester, silicone adhesive, isopropyl myristate, octyldodecanol, polybutene, polyisobutene, dimethicone NF, or polyolefin).
- 12. Have a diagnosis of schizophrenia or other major psychiatric diagnosis or mental illness (e.g. major depression).
- 13. Received an experimental agent (vaccine, drug, biologic, device, blood product or medication) within 1 month before enrollment in this study or expects to receive an experimental agent during the study.
- 14. Any condition that would, in the opinion of the Medically Accountable Investigator (MAI), place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
- 15. Inability to communicate or co-operate with the investigators.
- 16. History of consumption of alcohol within 24 hours prior to dose administration.
- 17. Within 72 hours prior to dosing, use of antihistamines or use of topical drugs at TDS site.
- 18. Subject has an obvious difference in skin color between arms or the presence of a skin condition, open sore, scar tissue, tattoo, or coloration that would interfere with placement of test articles, skin assessment, or reactions to drug.
- 19. Use of monoamine oxidase inhibitors 21 days prior to study.
- 20. Failure to pass opioid dependence challenge test on each procedure day before application of the fentanyl TDS. Each subject will be injected subcutaneously with naloxone HCl (0.8 mg injection) and will be observed for 45 minutes for signs and symptoms of opioid withdrawal.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland, Baltimore Center for Vaccine Development
Baltimore, Maryland, 21201
About this study
Official title: Determination of Serum Fentanyl Levels After Using Reference and Generic Transdermal Fentanyl TDSs With and Without Standardized Heat Application in Healthy Human Volunteers
This is an Open-label, Non-Randomized, 3-way Crossover Bioequivalence Study to compare fentanyl release after heating of a brand name (Duragesic) and generic (Apotex and Mylan) fentanyl (transdermal delivery system)TDSs in healthy adults.
Read the detailed description
This research study is intended to determine the effect of heat on FDA-approved fentanyl TDSs and whether the heat applied will result in more fentanyl being absorbed through the skin than without applying heat. This is important given that little is known about how the release of fentanyl is affected by heat, particularly for generic products. This study will use fentanyl TDSs (brand name and generic TDSs) that have been approved by the Food and Drug Administration (FDA) and are already prescribed to customers in the United States, and will not include any placebos.
- Conditions
- Peer Review, Research
- Being tested
- Duragesic reference fentanyl TDS, Apotex generic fentanyl TDS, Mylan generic fentanyl TDS
- Keywords
- Bioequivalence, Therapeutic Equivalency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duragesic reference fentanyl TDSDrug
Also called Brand name fentanyl TDS
25 µg/hour
Apotex generic fentanyl TDSDrug
Also called Generic fentanyl TDS
25 µg/hour
Mylan generic fentanyl TDSDrug
Also called Generic fentanyl TDS
25 µg/hour
| Study group | Role | What they receive |
|---|---|---|
| Duragesic Reference Fentanyl TDS | Experimental | Each volunteer participates in two procedure days using the Duragesic reference (RLD) fentanyl TDS with heating applied for one hour at hour 11 and hour 18, respectively. Receives: Drug: Duragesic reference fentanyl TDS |
| Apotex Generic Fentanyl TDS | Active comparator | Each volunteer participates in two procedure days using the Apotex generic fentanyl TDS with heating applied for one hour at hour 11 and hour 18, respectively. Receives: Drug: Apotex generic fentanyl TDS |
| Mylan Generic Fentanyl TDS | Active comparator | Each volunteer participates in two procedure days using the Mylan generic fentanyl TDS with heating applied for one hour at hour 11 and hour 18, respectively. Receives: Drug: Mylan generic fentanyl TDS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Partial Area Under the Curve (AUC) Attained With Early and Late Heat in Each of the Three Fentanyl TDSs (Reference and Generic)
Partial area under the flux-time curve of fentanyl calculated from 11 to 14 h for Early Heat and 18 to 21 h for Late Heat study designs
Blood samples obtained at 15 min prior to patch application [baseline], and at 1:00, 10:00, 10:55, 11:05, 11:15, 11:25, 11:35, 11:45, 12:00, 13:00, 14:00, 16:00, 17:00, 17:55, 18:05, 18:15, 18:25, 18:35, 18:45, 19:00, 20:00, 21:00, and 22:00 h post-patch application
Measured: six procedure days for each participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2015 (estimated)
- Study start9 Jul 2015
- Primary completion8 Aug 2017
- Study completion9 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peer Review, ResearchStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Responsible party
- Principal investigator, Audra Stinchcomb, University of Maryland, Baltimore
- Investigators
- Audra Stinchcomb, PhD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02486016
- Sponsor's protocol ID
- HP-00059884
- Status last verified
- Mar 2020
- First submitted
- 26 Jun 2015
- Last updated
- 23 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Serum Fentanyl Levels After Using Reference and Generic Transdermal Fentanyl TDSs With and Without Standardized Heat Application in Healthy Human Volunteers
- ClinicalTrials.gov ID
- NCT02486016
- Acronym / sponsor ID
- HP-00059884
- Conditions
- Peer Review, Research
- Keywords
- Bioequivalence, Therapeutic Equivalency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Study start
- 9 Jul 2015 (actual)
- Primary completion
- 8 Aug 2017 (actual)
- Study completion
- 9 Aug 2017 (actual)
- First posted
- 30 Jun 2015 (estimated)
- Results
- Posted 10 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an Open-label, Non-Randomized, 3-way Crossover Bioequivalence Study to compare fentanyl release after heating of a brand name (Duragesic) and generic (Apotex and Mylan) fentanyl (transdermal delivery system)TDSs in healthy adults.
Detailed description
This research study is intended to determine the effect of heat on FDA-approved fentanyl TDSs and whether the heat applied will result in more fentanyl being absorbed through the skin than without applying heat. This is important given that little is known about how the release of fentanyl is affected by heat, particularly for generic products. This study will use fentanyl TDSs (brand name and generic TDSs) that have been approved by the Food and Drug Administration (FDA) and are already prescribed to customers in the United States, and will not include any placebos.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Duragesic Reference Fentanyl TDS | Experimental | Drug: Duragesic reference fentanyl TDSEach volunteer participates in two procedure days using the Duragesic reference (RLD) fentanyl TDS with heating applied for one hour at hour 11 and hour 18, respectively. |
| Apotex Generic Fentanyl TDS | Active comparator | Drug: Apotex generic fentanyl TDSEach volunteer participates in two procedure days using the Apotex generic fentanyl TDS with heating applied for one hour at hour 11 and hour 18, respectively. |
| Mylan Generic Fentanyl TDS | Active comparator | Drug: Mylan generic fentanyl TDSEach volunteer participates in two procedure days using the Mylan generic fentanyl TDS with heating applied for one hour at hour 11 and hour 18, respectively. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- 1. Men or non-pregnant women of any ethnic background between the age of 18 and 45 years old.
- 2. Subjects must be non-smokers (must have refrained from the use of nicotine-containing substances, including tobacco products (e.g., cigarettes, cigars, chewing tobacco, gum, patch or electronic cigarettes) over the previous 2 months and are not currently using tobacco products.
- 3. Provide written informed consent before initiation of any study procedures.
- 4. Available for follow-up for the planned duration of the study.
- 5. Able to communicate well with the investigators.
Key exclusion criteria (23 listed)
- 1. Women who are pregnant, lactating, breast feeding or have a positive serum pregnancy test at enrollment or on the morning of any procedure day.
- 2. Smokers (current use or use over the previous 2 months of nicotine-containing substances, including tobacco products (e.g., cigarettes, cigars, chewing tobacco, gum, patch or electronic cigarettes).
- 3. Participation in any ongoing investigational drug trial or clinical drug trial.
- 4. Abnormal Vital signs, defined as:
- 5. Temperature > 38.0°C (100.4°F) or symptoms of an acute self-limited illness such as an upper respiratory infection or gastroenteritis within 7 days of application of the fentanyl TDS.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Duragesic reference fentanyl TDSAlso: Brand name fentanyl TDS25 µg/hour | Drug | Duragesic Reference Fentanyl TDS |
| Apotex generic fentanyl TDSAlso: Generic fentanyl TDS25 µg/hour | Drug | Apotex Generic Fentanyl TDS |
| Mylan generic fentanyl TDSAlso: Generic fentanyl TDS25 µg/hour | Drug | Mylan Generic Fentanyl TDS |
Primary outcome
Partial Area Under the Curve (AUC) Attained With Early and Late Heat in Each of the Three Fentanyl TDSs (Reference and Generic)
Time frame: six procedure days for each participant
Partial area under the flux-time curve of fentanyl calculated from 11 to 14 h for Early Heat and 18 to 21 h for Late Heat study designs Blood samples obtained at 15 min prior to patch application [baseline], and at 1:00, 10:00, 10:55, 11:05, 11:15, 11:25, 11:35, 11:45, 12:00, 13:00, 14:00, 16:00, 17:00, 17:55, 18:05, 18:15, 18:25, 18:35, 18:45, 19:00, 20:00, 21:00, and 22:00 h post-patch application
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Peer Review, Research
Not yet recruitingObservational study
Delphi Process to Achieve Global Consensus on Gender Equity in Critical Care
Professional Role, Research Peer Review
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Audra Stinchcomb, PhD principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Duragesic reference fentanyl TDS, Apotex generic fentanyl TDS and Mylan generic fentanyl TDS in people with Peer Review, Research, run by University of Maryland, Baltimore 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 17 inclusion and 23 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 23 Mar 2020. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Partial Area Under the Curve (AUC) Attained With Early and Late Heat in Each of the Three Fentanyl TDSs (Reference and Generic) (time frame: six procedure days for each participant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Mar 2020.