Efficacy of ORM-12741 for Prevention of Raynaud's Phenomenon (NCT01315899) | Clinical Trial Compass
TerminatedPhase 2
Efficacy of ORM-12741 for Prevention of Raynaud's Phenomenon
Stopped: Recommendation by study DSMC to the sponsor following interim analysis of 8 subjects.
United Kingdom15 participantsStarted 2011-03
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Written informed consent obtained
* Age of 10-75 years (inclusive)
* Body mass index (BMI) between 10-30 kg/m2 (inclusive)
* Male or female patients with a diagnosis of active Raynaud's phenomenon (RP) secondary to systemic sclerosis. Active RP will be defined as a history of cold sensitivity associated with colour changes of cyanosis or pallor, as well as of at least 6 attacks weekly during the winter months. Diagnosis of systemic sclerosis will be defined by the European League Against Rheumatism (EULAR) criteria.
* Stable symptoms for RP and medication requirements within 2 months prior to screening
* Negative pregnancy test for females of childbearing potential
Exclusion Criteria:
* Treatment with nitrates
* Treatment with calcium channel blockers (CCBs)for indications other than the relief of RP symptoms
* Treatment with calcium channel blockers (CCBs) for the relief of RP symptoms that in the opinion of the investigator cannot be stopped from the screening visit until end of the last experimental session
* Changes in dosing of other vasoactive medications within 1 month prior to screening or during the study
* Smoking or smoking cessation using nicotine products within 3 months prior to screening
* Current active ischemic digital ulcer and/or tissue gangrene
* History of sympathectomy
* Upper extremity deep vein thrombosis or lymphoedema within 3 months prior to screening.
* Clinically significant cardiovascular, pulmonary, gastrointestinal, hep…
What they're measuring
1
Finger temperature measurements and laser doppler imaging of the hands