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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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8 June 2015 |
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Main ID: |
NCT01316601 |
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Date of registration:
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14/03/2011 |
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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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A Study to Assess Efficacy, Safety and Tolerability of the Anti-IL-13 Monoclonal Antibody QAX576 in the Treatment of Perinanal Fistulas in Patients Suffering From Crohn's Disease
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Scientific title:
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Date of first enrolment:
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January 2011 |
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Target sample size:
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3 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01316601 |
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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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Switzerland
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Contacts
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Name:
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01 Studienregister MasterAdmins |
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Address:
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Telephone:
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Email:
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Affiliation:
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UniversitaetsSpital Zuerich |
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Key inclusion & exclusion criteria
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Inclusion criteria: - diagnosis of Crohn's disease > 6 month with fistula - at least 1
ineffective fistula treatment in the past
Exclusion criteria: - TNF a antibody treatment failed in the past
- planned surgery
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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Crohn's Disease
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Intervention(s)
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Drug: QAX567
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Primary Outcome(s)
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complete closure of fistula
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Secondary ID(s)
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Novartis CQAX576
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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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