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NCT02486016

Transdermal Patch CVD 2000: The Effect of Heat on Fentanyl Release From Fentanyl TDSs in Healthy Adults

Completed Phase 4 Results posted Last updated 23 March 2020
What this trial tests

Phase 4 trial testing Duragesic reference fentanyl TDS in Peer Review, Research in 10 participants. Completed in 9 August 2017.

Timeline
9 July 2015
Primary endpoint
8 August 2017
9 August 2017

Quick facts

Lead sponsorUniversity of Maryland, Baltimore
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designcrossover
Maskingnone
Primary purposehealth services research
Enrollment10
Start date9 July 2015
Primary completion8 August 2017
Estimated completion9 August 2017
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Maryland, Baltimore

Who can join

Adults 18 to 45, any sex, with Peer Review, Research. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Partial Area Under the Curve (AUC) Attained With Early and Late Heat in Each of the Three Fentanyl TDSs (Reference and Generic) Primary · 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

Early Heat (11 h)
GroupValue95% CI
Apotex Generic Fentanyl TDS2.2± 1.4
Duragesic Reference Fentanyl TDS1.7± 1.4
Mylan Generic Fentanyl TDS2.1± 1.8
Late Heat (18 h)
GroupValue95% CI
Apotex Generic Fentanyl TDS2.7± 1.4
Duragesic Reference Fentanyl TDS2.4± 1.0
Mylan Generic Fentanyl TDS2.9± 1.5

Adverse events — posted to ClinicalTrials.gov

Time frame: Minimum 19 weeks; the period of time was dependent on how long it took the volunteer to complete six procedure days with a minimum of 2 weeks washout between procedure days.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Apotex Generic Fentanyl TDS
Serious: 0/10 (0%)
Deaths: 0/10
Duragesic Reference Fentanyl TDS
Serious: 0/10 (0%)
Deaths: 0/10
Mylan Generic Fentanyl TDS
Serious: 0/10 (0%)
Deaths: 0/10
Other adverse events (7 terms — click to expand)

ReactionSystemApotex Generic Fentanyl TDSDuragesic Reference Fentan…Mylan Generic Fentanyl TDS
Increased respiratory rateRespiratory, thoracic and mediastinal disorders———
BradycardiaCardiac disorders———
Decreased respiratory rateRespiratory, thoracic and mediastinal disorders———
Abdominal crampingGastrointestinal disorders———
ErythemaSkin and subcutaneous tissue disorders———
HyperpigmentationSkin and subcutaneous tissue disorders———
Increased blood pressureCardiac disorders———

Data from ClinicalTrials.gov NCT02486016 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other University of Maryland, Baltimore trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02486016.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing