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

NCT02431624 | Completed Phase 1

• 2 other identifiers: BUP15082014-003421-18
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain

Keywords

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• Patch Adhesion score

  7 days

Secondary Outcomes (6)

• Observer Rating Scale of Patch prior to Removal questionnaire

  7 days

• Skin reaction assessment score

  day 8

• Adverse Events

  Up to 7-10 days post patch removal

• Changes in haematology and biochemistry values

  Up to 7-10 days after last patch removal

• Vital signs

  Up to 7-10 days after last patch removal

Study Arms (2)

Test treatment

EXPERIMENTAL

BTDS 40 milligram

Drug: BTDS

Reference treatment

ACTIVE COMPARATOR

BTDS 20 milligram

Drug: BTDS

Interventions

BTDS DRUG

Reference treatment; Test treatment

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• Subjects to be excluded from the study are those who meet any of the following criteria:
• Female subjects who are pregnant or lactating.
• Any history of drug or alcohol abuse.
• Any history of conditions that might interfere with drug absorption, distribution, metabolism or excretion.
• Use of opioid or opioid antagonist-containing medication in the past 30 days.
• Any history of frequent nausea or vomiting regardless of aetiology.
• Any history of seizures or symptomatic head trauma.
• 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.
• Any significant illness during the 4 weeks preceding entry into this study.
• 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).
• 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.
• 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).
• 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.

Sponsors & Collaborators

• Mundipharma Research Limited: lead

Study Sites (1)

BioKinetic Europe Ltd

Belfast, United Kingdom

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2015
• First Posted: May 1, 2015
• Study Start: March 1, 2015
• Primary Completion: May 1, 2015
• Study Completion: November 1, 2015
• Last Updated: February 9, 2016

Record last verified: 2016-02

Locations

GB (1)