NCT01315899

Efficacy of ORM-12741 for Prevention of Raynaud's Phenomenon

Phase IIa Study of the Efficacy of ORM-12471 for Prevention of Cold-induced Vasospasm: a Randomised, Double-blind, Placebo-controlled, Single Centre Crossover Study in Patients With Raynaud's Phenomenon Secondary to Systemic Sclerosis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Orion Corporation, Orion Pharma · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Raynaud's 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 blood the skin turns white then blue. The aim of this study is to prove the concept that ORM-12741 can prevent these blood vessel spasms.

Conditions

• Raynaud's Phenomenon

Interventions

Type	Name	Description
DRUG	ORM-12471 30mg	Given as a single dose once during the crossover study as per Williams design
DRUG	ORM-12471	Given as a single dose once during the study as per Williams crossover design
DRUG	placebo	Given once as a single dose during the study as per Williams crossover design

Timeline

• Start date: 2011-03-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2011-03-15
• Last updated: 2014-06-27

Locations

1 site across 1 country: United Kingdom