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

NCT00626665 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2013-03-22

No results posted yet for this study

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

Interventions

DRUG

Tadalafil

Tablets Tadalafil, 20 mg, alternate days, 6 weeks

Sponsors & Collaborators

  • Sanjay Gandhi Postgraduate Institute of Medical Sciences

    lead OTHER_GOV

Principal Investigators

  • Vikas Agarwal, MD, DM · Sanjay Gandhi Postgraduate Institute of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2008-04-30
Completion
2008-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00626665 on ClinicalTrials.gov