Trial Outcomes & Findings for Transdermal Patch CVD 2000: The Effect of Heat on Fentanyl Release From Fentanyl TDSs in Healthy Adults (NCT NCT02486016)

Last Updated: 2020-03-23

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

10 participants

Primary outcome timeframe

six procedure days for each participant

Results posted on

2020-03-23

Participant Flow

Participant milestones

Participant milestones
Measure	Fentanyl TDS Each volunteer participates in six procedure days. 1) Apotex generic fentanyl TDS (25 µg/h) with heat applied at 11 h for one hour 2) Apotex generic fentanyl TDS (25 µg/h) with heat at 18 h for one hour 3) Duragesic fentanyl TDS (25 µg/h) with heat applied at 11 h for one hour 4) Duragesic fentanyl TDS (25 µg/h) with heat at 18 h for one hour 5) Mylan generic fentanyl TDS (25 µg/h) with heat applied at 11 h for one hour 6) Mylan generic fentanyl TDS (25 µg/h) with heat at 18 h for one hour Two week wash out period between each procedure day.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fentanyl TDS n=10 Participants Each volunteer participates in six procedure days. 1. Apotex generic fentanyl TDS (25 µg/h) with heat applied at 11 h for one hour 2. Apotex generic fentanyl TDS (25 µg/h) with heat at 18 h for one hour 3. Duragesic fentanyl TDS (25 µg/h) with heat applied at 11 h for one hour 4. Duragesic fentanyl TDS (25 µg/h) with heat at 18 h for one hour 5. Mylan generic fentanyl TDS (25 µg/h) with heat applied at 11 h for one hour 6. Mylan generic fentanyl TDS (25 µg/h) with heat at 18 h for one hour Two week wash out period between each procedure day.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Sex: Female, Male Female	3 Participants n=99 Participants
Sex: Female, Male Male	7 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	2 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	6 Participants n=99 Participants
Race (NIH/OMB) White	2 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants

PRIMARY outcome

Timeframe: six procedure days for each participant

Population: Partial area under the flux-time curve of fentanyl from 11 to 14 h for Early Heat and 18 to 21 h for Late Heat study designs. Each was corrected to account for different TDS sizes. Comparison was early heat to late heat differences.

Outcome measures

Outcome measures
Measure	Apotex Generic Fentanyl TDS n=10 Participants 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. Apotex generic fentanyl TDS: 25 µg/hour	Duragesic Reference Fentanyl TDS n=10 Participants 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. Duragesic reference fentanyl TDS: 25 µg/hour	Mylan Generic Fentanyl TDS n=10 Participants 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. Mylan generic fentanyl TDS: 25 µg/hour
Partial Area Under the Curve (AUC) Attained With Early and Late Heat in Each of the Three Fentanyl TDSs (Reference and Generic) Early Heat (11 h)	2.2 h*ng/mL Standard Deviation 1.4	1.7 h*ng/mL Standard Deviation 1.4	2.1 h*ng/mL Standard Deviation 1.8
Partial Area Under the Curve (AUC) Attained With Early and Late Heat in Each of the Three Fentanyl TDSs (Reference and Generic) Late Heat (18 h)	2.7 h*ng/mL Standard Deviation 1.4	2.4 h*ng/mL Standard Deviation 1.0	2.9 h*ng/mL Standard Deviation 1.5

Adverse Events

Apotex Generic Fentanyl TDS

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Duragesic Reference Fentanyl TDS

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Mylan Generic Fentanyl TDS

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Apotex Generic Fentanyl TDS n=10 participants at risk 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. Apotex generic fentanyl TDS: 25 µg/hour	Duragesic Reference Fentanyl TDS n=10 participants at risk 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. Duragesic reference fentanyl TDS: 25 µg/hour	Mylan Generic Fentanyl TDS n=10 participants at risk 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. Mylan generic fentanyl TDS: 25 µg/hour
Cardiac disorders Bradycardia	90.0% 9/10 • Number of events 11 • 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.	80.0% 8/10 • Number of events 12 • 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.	50.0% 5/10 • Number of events 8 • 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.
Respiratory, thoracic and mediastinal disorders Decreased respiratory rate	40.0% 4/10 • Number of events 4 • 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.	50.0% 5/10 • Number of events 7 • 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.	60.0% 6/10 • Number of events 8 • 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.
Respiratory, thoracic and mediastinal disorders Increased respiratory rate	90.0% 9/10 • Number of events 15 • 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.	100.0% 10/10 • Number of events 15 • 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.	70.0% 7/10 • Number of events 10 • 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.
Skin and subcutaneous tissue disorders Hyperpigmentation	10.0% 1/10 • Number of events 1 • 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.	10.0% 1/10 • Number of events 1 • 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.	10.0% 1/10 • Number of events 1 • 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.
Cardiac disorders Increased blood pressure	10.0% 1/10 • Number of events 1 • 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.	10.0% 1/10 • Number of events 1 • 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.	10.0% 1/10 • Number of events 1 • 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.
Skin and subcutaneous tissue disorders Erythema	10.0% 1/10 • Number of events 1 • 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.	20.0% 2/10 • Number of events 2 • 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.	10.0% 1/10 • Number of events 2 • 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.
Gastrointestinal disorders Abdominal cramping	30.0% 3/10 • Number of events 4 • 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.	10.0% 1/10 • Number of events 1 • 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.	0.00% 0/10 • 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.

Additional Information

Dr. Audra Stinchomb (PI)

University of Maryland, Baltimore School of Pharmacy

Phone: 410-706-2646

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place