Prevention of cold-induced vasospasm in Raynaud's Phenomenon REINO

• Research type

  Research Study

• Full title

  Efficacy of ORM-12741 for prevention of cold-induced vasospasm; a randomised, double-blind, placebo-crontrolled, single centre crossover study in patients with Raynaud's phenomenon secondary to systemic sclerosis. Study number 3098009 REINO. EudraCT number 2010-024005-13.

• IRAS ID

  70562

• Contact name

  Ariane Herrick

• Sponsor organisation

  Orion Pharma

• Eudract number

  2010-024005-13

• ISRCTN Number

  0

• Clinicaltrials.gov Identifier

  0

• Research summary

  Raynauds phenomenon (RP) is a disorder of the digital blood vessels resulting in episodic impairment of blood flow. During an attack of RP, which commonly affects the hands and feet, these arteries contract briefly which limits the blood flow (this is called a vasospasm) and deprived of the blood the skin turns white and then blue. The aim of this study is to prove the concept that ORM-12741 can prevent these blood vessel spasms. The study will be conducted in a single site in the UK. The proposed duration of the study is from March 2011 to August 2011. A total of 18 subjects with Raynauds phenomenon secondary to systemic sclerosis will be recruited. Each study subject will be required to attend 5 study visits these comprise a screening visit, three visits when the study treatment will be administered and a follow up visit.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  11/H1010/2

• Date of REC Opinion

  11 Mar 2011

• REC opinion

  Further Information Favourable Opinion