drugset / Trial / NCT01117298
A Randomized Control Trial to Assess the Efficacy of Tadalafil in Raynaud's Phenomenon in Scleroderma
Phase 3
Completed
66 enrolled
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Army Hospital Research And Referral, India · collabInstitute of Postgraduate Medical Education and Research · collabPost Graduate Institute of Medical Education and Research, Chandigarh · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2009-11
- Primary completion
- 2010-04
- Completion
- 2010-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tadalafil | Small molecule | 20 mg | Oral |