Last reviewed · How we verify
NCT02798055: GRegistry SCDU
Bosentan Treatment of Digital Ulcers Related to Systemic Sclerosis
trial testing Bosentan group in Systematic Sclerosis in 148 participants. Completed in 30 June 2019.
30 June 2019
Quick facts
| Lead sponsor | Elpen Pharmaceutical Co. Inc. |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 148 |
| Start date | 30 September 2016 |
| Primary completion | 30 June 2019 |
| Estimated completion | 30 June 2019 |
| Sites | 1 location across Greece |
Drugs / interventions tested
- Bosentan group — full drug profile →
Conditions studied
- Systematic Sclerosis — all drugs for Systematic Sclerosis →
- Digital Ulcer — all drugs for Digital Ulcer →
- Scleroderma — all drugs for Scleroderma →
Sponsor
Elpen Pharmaceutical Co. Inc. — full company profile →
Who can join
Adults 18 to 80, any sex, with Systematic Sclerosis or Digital Ulcer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
The role of endothelin and RAS/ERK signaling in immunopathogenesis-related fibrosis in patients with systemic sclerosis: an updated review with therapeutic implications.
Rokni M, Sadeghi Shaker M, Kavosi H, Shokoofi S, et al · · 2022 · cited 20× · PMID 35562771 · DOI 10.1186/s13075-022-02787-w
Verify or expand the search:
- PubMed search for NCT02798055
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Elpen Pharmaceutical Co. Inc. trials
Trials by the same sponsor.
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- NCT06949956 — Administration of Fingolimod in Greek Patients With Multiple Sclerosis. · not yet recruiting
- NCT06528613 — Real World Study in Greek Patients with BPH for Disease Control and QoL Under FDC Treatment with Solifenacin/Tamsulosin. · recruiting
- NCT06117722 — TorasEmide Induced Effect on QoL and Clinical parameterS in paTients With chronIc heArt Failure Receiving Eplerenone. · unknown
- NCT05426915 — Clinical Study for the Effectiveness of Roflumilast Treatment in COPD Greek Patients Based on Standard Clinical Practice · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02798055 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Elpen Pharmaceutical Co. Inc.
- Last refreshed: 5 July 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02798055.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing