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

Scleroderma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01117298
• Other study ID #: B22:A15:PGI/DM/EC/40/7.11.2007
• Status: Completed
• Phase: Phase 3
• First received: May 3, 2010
• Last updated: May 7, 2010
• Start date: November 2009
• Est. completion date: May 2010

Study information

• Verified date: May 2010
• Source: Sanjay Gandhi Postgraduate Institute of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: May 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Digital Ulcers
• Raynaud Disease
• Raynaud's Phenomenon
• Scleroderma
• Scleroderma, Diffuse
• Scleroderma, Localized
• Scleroderma, Systemic

Intervention

Drug:
• Tadalafil
Tab Tadalafil, 20 mg alternate day for 8 weeks
• Placebo
Tab Placebo every alternate day for 8 weeks

Locations

Country	Name	City	State
India	Medicine Unit II, PGIMER	Chandigarh	Punjab
India	Immunology Rheumatology Unit, IPGMER	Kolkatta	WB
India	Department of Immunology, SGPGIMS	Lucknow	UP
India	Department of Clinical Immunology, Army R&R hospital	New Delhi	ND

Sponsors (4)

Lead Sponsor	Collaborator
Sanjay Gandhi Postgraduate Institute of Medical Sciences	Army Research and Referral hospital, Institute of Postgraduate Medical Education and Research, Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daily frequency, duration and severity of Raynaud's phenomenon		Baseline and 8 weeks	No
Primary	Appearance or healing of digital ulcers		Baseline and 8 weeks	No
Secondary	Improvement in health assessment questionnaire		Baseline and 8 weeks	No
Secondary	Improvement in scleroderma specific health assessment questionnaire		Baseline and 8 weeks	No
Secondary	Improvement in quality of life		Baseline and 8 weeks	No
Secondary	Improvement in biomarkers of endothelial dysfunction		Baseline and 8 weeks	No
Secondary	Improvement in flow mediated dilatation		Baseline and 8 weeks	No

External Links

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