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Trial NCT00000530

Resource URI: http://static.linkedct.org/resource/trials/NCT00000530
PropertyValue
linkedct:brief_title Raynaud's Treatment Study (RTS)
linkedct:condition <http://static.linkedct.org/resource/condition/11138>
linkedct:condition <http://static.linkedct.org/resource/condition/13668>
linkedct:condition <http://static.linkedct.org/resource/condition/2312>
linkedct:condition <http://static.linkedct.org/resource/condition/5702>
linkedct:criteria Men and women with documented primary or secondary Raynaud's syndrome.
linkedct:description BACKGROUND: Primary Raynaud's phenomenon is a peripheral vascular disorder resulting in vasospastic attacks provoked by cold and/or emotional stress. Attacks most often occur in the fingers, but may occur in other extremities as well. DESIGN NARRATIVE: Randomized. Patients were assigned to one of four treatment groups: slow release Nifedipine, a calcium channel blocker; pill placebo; temperature biofeedback; or electromyograph biofeedback from the frontalis muscle. The primary endpoint was reduction in number of vasospastic attacks. Other endpoints included: other measures of Raynaud's attacks including frequency, severity, duration, response to laboratory-based cold challenge, and quality of life.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 75 Years
linkedct:eligibility_minimum_age 18 Years
linkedct:end_date June 1998
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date October 27, 1999
linkedct:id NCT00000530
rdfs:label Trial NCT00000530
linkedct:lastchanged_date June 23, 2005
linkedct:lead_sponsor_agency National Heart, Lung, and Blood Institute (NHLBI)
linkedct:nct_id NCT00000530
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:org_study_id 73
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/6961>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000530>
linkedct:phase Phase 3
linkedct:reference <http://static.linkedct.org/resource/reference/10375>
linkedct:reference <http://static.linkedct.org/resource/reference/12354>
linkedct:reference <http://static.linkedct.org/resource/reference/3757>
linkedct:reference <http://static.linkedct.org/resource/reference/5059>
linkedct:reference <http://static.linkedct.org/resource/reference/7014>
linkedct:reference <http://static.linkedct.org/resource/reference/8713>
linkedct:source National Heart, Lung, and Blood Institute (NHLBI)
linkedct:start_date September 1992
linkedct:study_design Treatment, Randomized, Placebo Control
linkedct:study_type Interventional
linkedct:summary To determine the relative efficacy of usual medical care and a course of treatment by thermal biofeedback in reducing vasospastic attacks characteristic of Raynaud's syndrome. Also, to confirm the frequency and severity of attacks, examine the role of psychophysiological factors in precipitating attacks, and assess the influence of treatment on health quality of life.
rdf:type linkedct:trials
linkedct:verification_date August 2004