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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Raynaud's Phenomenon Digital Ulcers Scleroderma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Tadalafil

Group Type EXPERIMENTAL

Tadalafil

Intervention Type DRUG

Tab Tadalafil, 20 mg alternate day for 8 weeks

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Tab Placebo every alternate day for 8 weeks

Interventions

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Tadalafil

Tab Tadalafil, 20 mg alternate day for 8 weeks

Intervention Type DRUG

Placebo

Tab Placebo every alternate day for 8 weeks

Intervention Type DRUG

Other Intervention Names

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Tadalis

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No