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

NCT00626665 | Completed Phase 3

• 1 other identifier: A-15;PGI/DM/EC/40/7/11/07
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

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 will be observed and then the two groups will be switched over to receive the other drug. We planned a priori to include 20 patients. The concomitant medication for treatment of rheumatic disease remained unchanged during the whole study. Patient will undergo clinical and lab evaluation for organ damage for kidney and lungs. ECHO heart will be done at base line to assess the PAH and LV function and repeated at the end of the study. Blood pressure will be recorded at each visit. A physician unaware of the treatment group will record skin score and appearance of new cutaneous ulcers. The primary outcome variables will be frequency and duration of Raynauds attacks, evolution of trophic digital lesions and change in flow mediated dilatation of the brachial artery. Flow mediated dilatation of the brachial artery will be done at baseline 6 and 12 weeks.

Conditions

Raynaud Disease

Keywords

Raynaud disease; Scleroderma

Outcome Measures

Primary Outcomes (1)

• The primary outcome variables will be frequency and duration of Raynaud's attacks, evolution of trophic digital lesions

  6 weeeks and 12 weeks

Secondary Outcomes (1)

• change in flow mediated dilatation of the brachial artery

  6 weeks and 12 weeks

Study Arms (1)

Placebo

PLACEBO COMPARATOR

One placebo tablet every alternate day for 6 weeks

Drug: Tadalafil

Interventions

Tadalafil DRUG

Tablets Tadalafil, 20 mg, alternate days, 6 weeks

Also known as: Tadalis

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanjay Gandhi Postgraduate Institute of Medical Sciences: lead

Related Publications (1)

• Shenoy PD, Kumar S, Jha LK, Choudhary SK, Singh U, Misra R, Agarwal V. Efficacy of tadalafil in secondary Raynaud's phenomenon resistant to vasodilator therapy: a double-blind randomized cross-over trial. Rheumatology (Oxford). 2010 Dec;49(12):2420-8. doi: 10.1093/rheumatology/keq291. Epub 2010 Sep 12.

  PMID: 20837499 RESULT

MeSH Terms

Conditions

Raynaud Disease; Scleroderma, Diffuse

Interventions

Tadalafil

Condition Hierarchy (Ancestors)

Livedoid Vasculopathy; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Scleroderma, Systemic; Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Vikas Agarwal, MD, DM

  Sanjay Gandhi Postgraduate Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Additional Professor

Study Record Dates

• First Submitted: February 21, 2008
• First Posted: February 29, 2008
• Study Start: December 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: March 22, 2013

Record last verified: 2013-03