An Assessment of Buprenorphine Transdermal Delivery System (BTDS) Patch Adhesion

NCT ID: NCT02431624

Last Updated: 2016-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2015-11-30

Brief Summary

The purpose of this study is to assess the adhesion of BTDS patch 40 µg/h.

Detailed Description

The objective is to show non-inferiority in adhesion of BTDS patch 40 µg/h compared to BTDS patch 20 µg/h. Safety and tolerability of both patches will also be assessed.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

Test treatment

BTDS 40 milligram

Group Type: EXPERIMENTAL

BTDS

Intervention Type: DRUG

Reference treatment

BTDS 20 milligram

Group Type: ACTIVE_COMPARATOR

BTDS

Intervention Type: DRUG

Interventions

BTDS

Intervention Type: DRUG

Eligibility Criteria

Exclusion Criteria

Subjects to be excluded from the study are those who meet any of the following criteria:

1. Female subjects who are pregnant or lactating.

2. Any history of drug or alcohol abuse.

3. Any history of conditions that might interfere with drug absorption, distribution, metabolism or excretion.

4. Use of opioid or opioid antagonist-containing medication in the past 30 days.

5. Any history of frequent nausea or vomiting regardless of aetiology.

6. Any history of seizures or symptomatic head trauma.

7. Participation in a clinical drug study during the 90 days preceding the initial dose in this study, or participation in any other clinical drug study during this study.

8. Any significant illness during the 4 weeks preceding entry into this study.

9. A history of additional risk factors for Torsades de Pointes (e.g. heart failure, hypokalaemia, personal or family history of long QT syndrome, syncope, or family history of sudden death).

10. Abnormal cardiac conditions including any of the following:

• QTcF interval greater than 450 msec at screening or at check-in before first dosing.
• Increase in QTcF of more than 60 msec above pre-dose values of each study period or QTcF > 500 msec at any time during the study.

11. Use of medication within 5 times the half-life or minimum 14 days for prescription medication or 7 days for over-the-counter preparations (including vitamins, herbal and/or mineral supplements), whichever is longer, before the first dose of study treatment and during the study (with the exception of the continued use of Hormone Replacement Therapy (HRT) and contraceptives).

12. Refusal to abstain from caffeine or xanthine containing beverages and grapefruit juice within 48 hours before IMP administration until after the last study measure has been performed in each study period.

13. Weekly alcohol intake exceeding the equivalent of 14 units/week for females and 21 units/week for males.

14. Consumption of alcoholic beverages within 48 hours before IMP administration, and refusal to abstain from alcohol for the duration of the study confinement and for at least 48 hours after the last naltrexone dose in each study period.

15. History of smoking within 45 days of IMP administration and refusal to abstain from smoking during the study.

16. Positive results of urine drug screen, alcohol test and pregnancy test.

17. Known sensitivity to buprenorphine, naltrexone, related compounds or any of the excipients or any contraindications as detailed in the Butrans Summary of Product Characteristics or Nemexin Summary of Product Characteristics.

18. Clinically significant history of allergic reaction to wound dressings or elastoplast.

19. Subjects with any dermatological disorder or tattoos at the proposed sites of patch application, or with a history of eczema/cutaneous atrophy.

20. Subjects who will not allow hair to be removed at the proposed patch application sites which may prevent proper placement of the patch.

21. Refusal to allow their primary care physician to be informed of participation in the trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mundipharma Research Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

BioKinetic Europe Ltd

Belfast, , United Kingdom

Countries

United Kingdom

Other Identifiers

2014-003421-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BUP1508

Identifier Type: -

Identifier Source: org_study_id