Cross-over study with fentanyl patch in healthy Japanese volunteers

• Research type

  Research Study

• Full title

  An Open-Label, Single-Dose, Randomized, Two-Period, Cross-Over Bioequivalence Study of a novel fentanyl patch 11.0 mg and Durotep® MT Patch 16.8 mg in Healthy Japanese Male Volunteers

• IRAS ID

  79524

• Sponsor organisation

  CRS Clinical Research Services Mannheim GmbH

• Eudract number

  2011-002031-25

• ISRCTN Number

  n/a

• Research summary

  Pain is an unpleasant sensation that can range from mild, localised discomfort to agony and is often classified as being acute or chronic in nature. Acute pain includes trauma or disease and usually has a well defined location and timing. Chronic pain on the other hand is defined as pain lasting more than a few months. Fentanyl is a powerful opioid analgesic which is approximately 100 times more potent than morphine. It was developed in the 1960s and has been used as a strong painkiller, being both safe and effective. Chronic pain treatment by continuous administration is necessary and can be achieved by using transdermal patches (plasters containing a certain amount of medication), released through the skin over time. The transdermal route of medication administration would be beneficial for patients where swallowing or intravenous injections are difficult or unacceptable.The main aim of the study is to see how the study drug (a novel fentanyl patch) is handled by the body in comparison to Durotep© MT patch and to investigate how well healthy Japanese male volunteers tolerate different types of patches.This is a single centre study and will be performed in two stages. Stage 1 will involve 30 healthy Japanese males. Stage 2 will involve 40 healthy Japanese males. Each volunteer will receive two different treatments in two periods (Period 1 and Period 2): novel fentanyl patch (11.0 mg x 1 patch) and Durotep© MT patch (16.8 mg x 1 patch). There will at least an 11 days wash-out period between both treatments.If the objectives are met in Stage 1 or if they are considered impossible even if conducting Stage 2, then Stage 2 will not be conducted. The number of subjects, assessments and procedures in Stage 2 are decided based on the result of Stage 1.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  11/LO/0763

• Date of REC Opinion

  29 Jun 2011

• REC opinion

  Further Information Favourable Opinion