Status:
COMPLETED
Safety and Efficacy Study of Depelestat in Acute Respiratory Distress Syndrome (ARDS) Patients
Lead Sponsor:
Debiopharm International SA
Conditions:
Fibrosis
Lung Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The study is aimed to assess safety of Depelestat treatment, as well as efficacy on prevention and treatment of alveolar inflammation in early pulmonary fibrosis in patients suffering from persistent ...
Detailed Description
This is a multicenter, randomised, double-blind, parallel groups, placebo-controlled, 1 week treatment of Depelestat, in patients suffering from persistent ARDS. Patients admitted in the intensive ca...
Eligibility Criteria
Inclusion
- Patients suffering from persistent ARDS as defined by the American and European Consensus Conference on ARDS, 1994
Exclusion
- ARDS secondary to traumatism
- Pulmonary emphysema on pulmonary fibrosis
- Lung pneumocystosis
- Bronchopleural fistula
- Systemic corticosteroid treatment for more than 2 weeks before inclusion
- Severe organ disease excepted renal
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT00455767
Start Date
July 1 2006
End Date
September 1 2007
Last Update
June 24 2008
Active Locations (14)
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1
Alain Mercat
Angers, France, 49933
2
Yves Castaing
Bordeaux, France, 33076
3
Laurent Brochard
Créteil, France, 94010
4
Jean-François Timsit
Grenoble, France, 38043