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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00624273 |
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Date of registration:
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14/02/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Sildenafil for Treatment of Digital Ulcers in Patients With Systemic Sclerosis
Sildenafil |
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Scientific title:
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Effect of Sildenafil on Digital Ulcers in Systemic Sclerosis |
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Date of first enrolment:
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February 2004 |
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Target sample size:
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17 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00624273 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Germany
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Contacts
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Name:
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Dr. Gabriela Riemekasten, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Charité Universitätsklinik Berlin |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Digital gangrene, ulcers in patients with severe secondary Raynaud`s phenomenon
2. Stable therapy with vasoactive drugs, such as calcium channel blockers, angiotensin
inhibitors/AT II receptor antagonists or pentoxifyllin 4 weeks before and during the
treatment with sildenafil.
3. Unchanged immunosuppressive therapy 3 months before treatment with sildenafil
4. No effect of prostacyclin treatment, contraindications for prostacyclins, or other
reasons excluding this therapy
Exclusion Criteria:
1. Therapy with iloprost during the last 4 weeks
2. Sympathectomy during the last 4 weeks
3. TIA, stroke, myocardial infarction during the last 6 months
4. Instable angina pectoris
5. Hemorrhagic diathesis, thrombocytic dysfunction, fibromuscular dysplasia
6. Microangiopathic hemolytic anaemia
7. Azotaemia
8. Hypertonus not adjustable with diuretic, clonidine, ACE inhibitors/AT II antagonists,
calcium channel blockers)
9. Left ventricular ejection fraction< 20%
10. Hypotonus < 80/40 mm Hg
11. Positive pregnancy test
12. History of cancer
13. History of gastric/duodenic ulcers without endoscopic proof of complete healing
14. Participation in other studies (currently or during the last 4 weeks)
15. Abuse of alcohol or other drugs, smoker
16. Cardiac failure, use of nitrates
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Active Digital Ulcers
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Intervention(s)
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Drug: Sildenafil therapy
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Primary Outcome(s)
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healing of digital ulcer
[Time Frame: 6 months]
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Secondary Outcome(s)
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Prevention of necroses manifestations
[Time Frame: 6 months]
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Decrease of frequency/duration of Raynaud's attacks (monthly)
[Time Frame: 6 months]
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Secondary ID(s)
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SDN-D-002G
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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