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

NCT01315899 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2014-06-27

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Orion Corporation, Orion Pharma

    lead INDUSTRY

Principal Investigators

  • Ariane L Herrick, MB,ChB, MD · Northern Care Alliance NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • United Kingdom

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01315899 on ClinicalTrials.gov