NCT01117298

A Randomized Control Trial to Assess the Efficacy of Tadalafil in Raynaud's Phenomenon in Scleroderma

A Randomized Control Trial to Assess the Efficacy of Tadalafil in Raynaud's Phenomenon in Scleroderma: A Double Blind, Parallel Group, Multicentric Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Sanjay Gandhi Postgraduate Institute of Medical Sciences · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Raynaud's phenomenon (RP) associated with scleroderma is a difficult problem to treat. Many patients develop ischemic digital ulcers due to severe RP that causes considerable morbidity and adversely affects the quality of life. In an earlier study, we have observed marked improvement in RP attacks and rapid healing of digital ulcers following therapy with phosphodiesterase V inhibitor, Tadalafil. In the present multicentric study we aim to study the efficacy of Tadalafil in patients continuing to have RP attacks despite using at least one or more vasodilators.

Conditions

• Raynaud's Phenomenon
• Digital Ulcers
• Scleroderma

Interventions

Type	Name	Description
DRUG	Tadalafil	Tab Tadalafil, 20 mg alternate day for 8 weeks
DRUG	Placebo	Tab Placebo every alternate day for 8 weeks

Timeline

• Start date: 2009-11-01
• Primary completion: 2010-04-01
• Completion: 2010-05-01
• First posted: 2010-05-05
• Last updated: 2010-05-10

Locations

4 sites across 1 country: India