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

NCT01117298 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2010-05-10

No results posted yet for this study

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.

Conditions

  • Raynaud's Phenomenon
  • Digital Ulcers
  • Scleroderma

Interventions

DRUG

Tadalafil

Tab Tadalafil, 20 mg alternate day for 8 weeks

DRUG

Placebo

Tab Placebo every alternate day for 8 weeks

Sponsors & Collaborators

  • Institute of Postgraduate Medical Education and Research

    collaborator AMBIG

  • Post Graduate Institute of Medical Education and Research, Chandigarh

    collaborator OTHER

  • Army Hospital Research And Referral, India

    collaborator OTHER

  • Sanjay Gandhi Postgraduate Institute of Medical Sciences

    lead OTHER_GOV

Principal Investigators

  • Parasar Ghosh, MD, DM · IPGMER, Kolkatta

  • Aman Sharma, MD · PGIMER, Chandigarh

  • Darshan S Bhakuni, MD · Army R&R Hospital, New Delhi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2010-04-30
Completion
2010-05-31

Countries

  • India

Study Locations

More Related Trials

Entities

Drugs

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 NCT01117298 on ClinicalTrials.gov