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

Phase 1

Completed

• Conditions: Pain
• Interventions: Drug: BTDS

• Registration Number: NCT02431624
• Lead Sponsor: Mundipharma Research Limited

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.

Study Timeline

• Study First Submitted: 2015-02-25
• Study Start: 2015-03
• Study First Submitted QC: 2015-04-30
• Primary Completion: 2015-05
• Study First Posted: 2015-05-01
• Study Completion: 2015-11
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-08
• Last Update Posted: 2016-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Test treatment	BTDS	BTDS 40 milligram
Reference treatment	BTDS	BTDS 20 milligram

Primary Outcome Measures

Name	Time	Method
Patch Adhesion score	7 days

Secondary Outcome Measures

Name	Time	Method
Observer Rating Scale of Patch prior to Removal questionnaire	7 days	does the patch shift, buckle, curl, fall off, change colour or smell
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
ECG	Up to 7-10 days after last patch removal

Trial Locations

Locations (1)

BioKinetic Europe Ltd; 🇬🇧 Belfast, United Kingdom