Proof of concept study of OC000459 in eosinophilic esophagitis (clinicaltrials.gov) - Jan 4, 2012 - P2, N=26; Active, not recruiting -> Completed
Trial completion
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This study has been completed.
First Received on January 25, 2010. Last Updated on January 4, 2012 History of Changes
Sponsor: Oxagen Ltd
Information provided by (Responsible Party): Oxagen Ltd
ClinicalTrials.gov Identifier: NCT01056783
Purpose
This will be a randomised, double blind, placebo controlled, parallel group evaluation of the effect of OC000459 given orally for eight weeks on active eosinophilic esophagitis.
Condition
Eosinophilic Esophagitis
Intervention
Drug: OC000459
Drug: Placebo
Phase
Phase II
Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-controlled, Double-blind, Single-centre Proof-of-concept Study of OC000459 in Adult Patients With Active Eosinophilic Esophagitis
Further study details as provided by Oxagen Ltd:
Primary Outcome Measures:
Effect of OC000459 on eosinophil load of the esophageal tissue [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
Effect of OC000459 on clinical manifestations of EoE [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Effect of OC000459 on endoscopic alterations [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Effect of OC000459 on EoE related blood and tissue biomarkers [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Safety and tolerability of OC000459 in patients with active EoE [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Enrollment: 26
Study Start Date: August 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
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