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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: |
NCT00455767 |
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Date of registration:
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14/03/2007 |
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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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Safety and Efficacy Study of Depelestat in Acute Respiratory Distress Syndrome (ARDS) Patients
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Scientific title:
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Phase IIA Multicenter 1 Week Treatment, Randomised, Double-Blind, Placebo Controlled Study of Depelestat in Patients Suffering From Acute Respiratory Distress Syndrome |
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Date of first enrolment:
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July 2006 |
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Target sample size:
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84 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00455767 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), 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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France
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Italy
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Spain
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Tunisia
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Contacts
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Name:
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François Saudubray, 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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Debiopharm SA |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients suffering from persistent ARDS as defined by the American and European
Consensus Conference on ARDS, 1994
Exclusion Criteria:
- 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Fibrosis
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Inflammation
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Lung Disease
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Respiratory Distress Syndrome, Adult
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Acute Respiratory Distress Syndrome
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Pulmonary Fibrosis
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Respiratory Disorders
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Intervention(s)
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Drug: EPI-hNE4
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Drug: Placebo
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Primary Outcome(s)
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Static compliance relative change from pre-treatment to last on treatment
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Secondary Outcome(s)
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PCPIII and cytokines concentration, as well as neutrophil influx relative change in BAL fluid from pre-treatment to post-treatment
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Secondary ID(s)
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2006-000756-41 (EUDRACT NR)
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DEB-EPIV-201
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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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