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

Sanjay Gandhi Postgraduate Institute of Medical Sciences

Status and phase

Completed

Phase 3

Conditions

Scleroderma

Raynaud's Phenomenon

Digital Ulcers

Treatments

Drug: Tadalafil

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01117298

B22:A15:PGI/DM/EC/40/7.11.2007

Details and patient eligibility

About

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.

Enrollment

66 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female subjects between the ages of 18 years and 65 years will be selected for the study if they have a clinical diagnosis of Raynaud's phenomenon secondary to systemic sclerosis (scleroderma) despite being on vasodilator therapy. Raynaud's phenomenon is defined as a history of cold sensitivity associated with colour changes of cyanosis or pallor. Patients with a history of at least 4 attacks per week during two-week pre-trial period even with treatment with other vasodilators will be recruited. Patients fulfilling the diagnostic criteria of scleroderma (as per American College of Rheumatology criteria) or having presence of at least 3 of the 5 features of the CREST syndrome (calcinosis, Raynaud's phenomenon, esophageal dysmotility, sclerodactyly, telangiectasias)will be invited to participate in the study.

Exclusion criteria

Patients with:

Symptomatic orthostatic hypotension,
Evidence of current malignancy,
History of sympathectomy,
Upper extremity deep vein thrombosis or lymphedema within 3 months,
Recent surgical procedure requiring general anesthesia,
Acute Myocardial Infarction, unstable angina, strokes and transient ischemic attacks within the past three months,
Smoking,
Use of any investigational drug within 30 days of the study sessions,
Use of medications that might interfere with tadalafil like nitrates and alpha adrenergic blockers that have vasoactive effects, and patients taking potent inhibitors of CYP3A4 such as ritonavir, ketoconazole, and itraconazole, erythromycin, itraconazole, and grapefruit juice,
Patients taking alcohol,
Patients with bleeding disorders
Significant active peptic ulceration,
Current pregnancy,
Current breast-feeding.