Fentanyl patch dose proportionality study in Japanese volunteers

• Research type

  Research Study

• Full title

  A Randomized, Open-Label, Three-Period, Ten-Sequence, Five-Treatment, Cross-Over Study to Assess Dose Proportionality of Single-Dose Administration of a Novel Fentanyl Patch in Healthy Japanese Male Volunteers

• IRAS ID

  92967

• Contact name

  Ulrike Lorch

• Sponsor organisation

  CRS Clinical Research Services Mannheim GmbH

• Eudract number

  2011-004713-16

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  We are conducting a study to compare different size novel fentanyl transdermal (through the skin) patches which will have different concentrations of fentanyl (study drug) to see if the response to the study drug is proportional to the concentration given. We have recently completed a similar study in Japanese volunteers to see if the effects of fentanyl transdermal patches are similar (bioequivalent) to a marketed patch. The study drug will be applied for 72 hours and the concentration of study medication in the blood will be measured. We are performing the study in Japanese volunteers since the target population for the study patch is Japanese patients. Japan does not allow studies involving opioid based drugs in healthy volunteers. Therefore, the study is being performed in Japanese volunteers outside of Japan in the UK. Japanese law requires that any drug to be given to Japanese patients must be tested in Japanese volunteers. The study will be done at a single centre using a three-period crossover study (different patches applied at each of the 3 periods) performed in 30 volunteers. Each volunteer will be randomised to 1 of 10 sequences each describing which three pacthes will be applied). Each period will be separated by at least 11 days between patch removal and application. Each volunteer will receive three of five treatments (novel fentanyl patch 1.38 mg x 1 patch [12.5 æg/hr], 2.75 mg x 1 patch [25 æg/hr], 5.5 mg x 1 patch [50 æg/hr], 8.25 mg x 1 patch [75 æg/hr] and 11.0 mg x 1 patch [100 æg/hr]) in sequence from a lower dose to higher dose during the three periods. Fentanyl transdermal patches (plasters containing a certain amount of painkiller medication) are used in the treatment of severe chronic pain such as that in cancer patients.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  11/IE/0175

• Date of REC Opinion

  28 Nov 2011

• REC opinion

  Further Information Favourable Opinion