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Sildenafil for Treatment of Digital Ulcers in Patients With Systemic Sclerosis (Sildenafil)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00624273
First Posted: February 27, 2008
Last Update Posted: January 7, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Charite University, Berlin, Germany
  Purpose
This is a pilot study analyzing the effect of sildenafil therapy on digital ulcers in systemic sclerosis. We want to analyze ulcer healing by measuring the size of digital ulcers and their count and analyze the effect of sildenafil on angiography.

Condition Intervention Phase
Active Digital Ulcers Drug: Sildenafil therapy Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Sildenafil on Digital Ulcers in Systemic Sclerosis

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • healing of digital ulcer [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Decrease of frequency/duration of Raynaud's attacks (monthly) [ Time Frame: 6 months ]
  • Prevention of necroses manifestations [ Time Frame: 6 months ]

Enrollment: 17
Study Start Date: February 2004
Study Completion Date: February 2007
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1, active ulcers
sildenafil treatment
Drug: Sildenafil therapy
oral use
Other Name: start at 25 mg

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00624273


Locations
Germany
Riemekasten, PD Dr. med.
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Dr. Gabriela Riemekasten, MD Charité Universitätsklinik Berlin
  More Information

Responsible Party: PD Dr. Gabriela Riemekasten, Charité Universitäsmedizin
ClinicalTrials.gov Identifier: NCT00624273     History of Changes
Other Study ID Numbers: SDN-D-002G
First Submitted: February 14, 2008
First Posted: February 27, 2008
Last Update Posted: January 7, 2009
Last Verified: July 2003

Keywords provided by Charite University, Berlin, Germany:
digital ulcers,
systemic sclerosis,
sildenafil,
vasoactive therapies

Additional relevant MeSH terms:
Sclerosis
Ulcer
Scleroderma, Systemic
Scleroderma, Diffuse
Skin Ulcer
Pathologic Processes
Connective Tissue Diseases
Skin Diseases
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents