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Bosentan Treatment of Digital Ulcers Related to Systemic Sclerosis

NCT02798055 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 148

Last updated 2019-07-05

No results posted yet for this study

Summary

GRegistry is a significant collection of data and information on the clinical practice of systemic scleroderma finger ulcers.

The GRegistry study is a nationwide (Greece) prospective study recording, which includes consecutive patients with SC-DU diagnosis in clinical management departments of different hospitals, selected in such a way as to reflect a representation of the country.

The use of Bosentan in the treatment of patients suffering from systemic sclerosis with digital ulcer disease is supported by data from large, placebo-controlled, randomized studies. The beneficial effect of Bosentan in digital ulcers, a vascular event of systemic sclerosis consistent with its beneficial effect on pulmonary arterial hypertension associated with connective tissue disease and its beneficial effect on vascular remodeling.

Conditions

  • Systematic Sclerosis
  • Digital Ulcer
  • Scleroderma

Interventions

DRUG

Bosentan group

Sponsors & Collaborators

  • Elpen Pharmaceutical Co. Inc.

    lead INDUSTRY

Eligibility

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

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2019-06-30
Completion
2019-06-30

Countries

  • Greece

Study Locations

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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 NCT02798055 on ClinicalTrials.gov