Randomised Control Trial to Assess the Efficacy of Tadalafil in Raynaud's Phenomenon in Scleroderma
Status:
Completed
Trial end date:
2008-04-01
Target enrollment:
Participant gender:
Summary
In this double-blinded, placebo-controlled, fixed-dose, study patients will be randomly
assigned to take placebo or 20 mg tadalafil thrice weekly for 6 weeks. After 6 weeks a wash
out period of 2 week will be observed and then the two groups will be switched over to
receive the other drug. We planned a priori to include 20 patients. The concomitant
medication for treatment of rheumatic disease remained unchanged during the whole study.
Patient will undergo clinical and lab evaluation for organ damage for kidney and lungs. ECHO
heart will be done at base line to assess the PAH and LV function and repeated at the end of
the study. Blood pressure will be recorded at each visit. A physician unaware of the
treatment group will record skin score and appearance of new cutaneous ulcers. The primary
outcome variables will be frequency and duration of Raynauds attacks, evolution of trophic
digital lesions and change in flow mediated dilatation of the brachial artery. Flow mediated
dilatation of the brachial artery will be done at baseline 6 and 12 weeks.
Phase:
Phase 3
Details
Lead Sponsor:
Sanjay Gandhi Postgraduate Institute of Medical Sciences