Status:
COMPLETED
Randomised Control Trial to Assess the Efficacy of Tadalafil in Raynaud's Phenomenon in Scleroderma
Lead Sponsor:
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Conditions:
Raynaud Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief 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...
Detailed Description
Introduction Raynaud's syndrome, which was first described by Maurice Raynaud in 1862, is defined as episodic cold or emotional stress-triggered ischemic vasospasms of the digital arteries and precapi...
Eligibility Criteria
Inclusion
- Male or female subjects between the ages of 18 years and 60 years will be selected for the study if they have a clinical diagnosis of Raynaud's phenomenon secondary to systemic sclerosis (scleroderma). Raynaud's phenomenon is defined as a history of cold sensitivity associated with colour changes of cyanosis or pallor, as well as a history of at least 4 attacks per week during two pre-trial period even with treatment with other vasodilators. The diagnosis of scleroderma is defined by the American College of Rheumatology (ACR) criteria or by the presence of at least 3 of the 5 features of the CREST syndrome (calcinosis, Raynaud's phenomenon, esophageal dysmotility, sclerodactyly, telangiectasias).
Exclusion
- Patients will be excluded if they have:
- 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
- AMI, unstable angina, strokes and TIA 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
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00626665
Start Date
December 1 2007
End Date
April 1 2008
Last Update
March 22 2013
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