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.
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