Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Sildenafil for Treatment of Digital Ulcers in Patients With Systemic Sclerosis

This study has been completed.
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00624273
First received: February 14, 2008
Last updated: January 6, 2009
Last verified: July 2003
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

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

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: PD Dr. Gabriela Riemekasten, Charité Universitäsmedizin
ClinicalTrials.gov Identifier: NCT00624273     History of Changes
Other Study ID Numbers: SDN-D-002G, SDN-D-002G
Study First Received: February 14, 2008
Last Updated: January 6, 2009
Health Authority: Germany: Ethics Commission

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

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

ClinicalTrials.gov processed this record on November 20, 2014