Abstract
We present a phase 1 study that utilizes a crossover design that provides a rapid and relatively inexpensive methodology for evaluating a new transdermal product. The treatment for osteoarthritis (OA) aims to reduce pain and improve function. An innovative magnetophoresis technology has been developed that facilitates transdermal delivery of ibuprofen. The study used measures that were taken over a relatively short time period to monitor the pharmacodynamic response to ibuprofen. Each participant received magnetophoresis-enhanced transdermal ibuprofen or placebo in randomised order, with a five-day washout period. The participants were 24 volunteers with medically diagnosed, painful knee OA. The primary outcome measures were VAS rating of pain on movement and Western Ontario and McMaster Universities (WOMAC) pain and function scores. VAS for pain on movement (p < 0.001), WOMAC pain score (p = 0.004), and WOMAC function score (p = 0.004) were all significantly improved. There was a significant reduction in movement-related pain (p < 0.05) during the first patch application and for the remainder of the study period. The number needed to treat for a 50% reduction in movement related pain was 2.2. The study showed a rapid and significant analgesic effect in response to transdermal ibuprofen. A short trial of this nature can be used for informing the parameters that are required for a major randomised controlled trial.
Highlights
In the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), Harmonised Tripartite Guideline developed in 2008, the committee stated that, in all cases, a pharmaceutical “product should be designed to meet patients’ needs and the intended product performance” [1]
This relatively inexpensive phase 1 trial methodology provides an indication of the relative clinical efficacy of the new transdermal product to evaluate the product viability and provide data for underpinning the design of a major randomised controlled trial (RCT)
There was no significant reduction in the total time that was required to complete a series of three functional tasks (ALF), there was a significant reduction in the time for the walk task and a significant reduction in the level of pain that participants experienced while completing each of the three component tasks
Summary
In the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), Harmonised Tripartite Guideline developed in 2008, the committee stated that, in all cases, a pharmaceutical “product should be designed to meet patients’ needs and the intended product performance” [1]. This paper describes the toolkit’s application in a short-term, crossover trial to evaluate the key clinical parameters for a novel transdermal patch that delivered a non-steroidal anti-inflammatory drug (NSAID) to painful osteoarthritic knees. This relatively inexpensive phase 1 trial methodology provides an indication of the relative clinical efficacy of the new transdermal product to evaluate the product viability and provide data for underpinning the design of a major randomised controlled trial (RCT)
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