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Proof of Concept Study of OC000459 in Eosinophilic Esophagitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01056783
First Posted: January 26, 2010
Last Update Posted: January 5, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Oxagen Ltd
  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 Intervention Phase
Eosinophilic Esophagitis Drug: OC000459 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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

Resource links provided by NLM:


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 ]

Secondary Outcome Measures:
  • Effect of OC000459 on clinical manifestations of EoE [ Time Frame: 8 weeks ]
  • Effect of OC000459 on endoscopic alterations [ Time Frame: 8 weeks ]
  • Effect of OC000459 on EoE related blood and tissue biomarkers [ Time Frame: 8 weeks ]
  • Safety and tolerability of OC000459 in patients with active EoE [ Time Frame: 8 weeks ]

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)
Arms Assigned Interventions
Experimental: OC000459
OC000459 100mg twice daily
Drug: OC000459
OC000459 100mg, twice daily, tablet
Placebo Comparator: Placebo Drug: Placebo
Placebo tablets to match OC000459 tablets, twice daily

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Previously diagnosed and symptomatic isolated eosinophilic esophagitis.
  • Relevant eosinophil tissue inflammation as demonstrated by a mean eosinophil load >= 20 eos/hpf in 8 biopsies at the baseline visit.
  • Able to swallow placebo medication successfully under supervision in the clinic
  • Free of all medications for EoE (including topical steroids) for at least 2 weeks prior to baseline and free of systemic steroids for at least 90 days before screening. A proton-pump inhibitor is allowed if required for treatment of secondary acid reflux.

Exclusion Criteria:

  • Other causes of esophagitis (GERD, peptic ulceration, infection etc.)
  • Other causes of eosphagaeal or generalized eosinophilia (i.e. hypereosinophilic syndromes, parasitic infection, GERD)
  • The patient's EoE is dependant on the level of seasonal allergens and the patient's participation in the study will occur during the allergy season.
  • History of abnormal gastric or duodenal eosinophilia (e.g. HES, Churg Strauss vasculitis, EG or a parasitic infection)
  • Receipt of forbidden prescribed or over the counter medication within the 4 weeks prior to the baseline visit and for the duration of the trial, including vitamins and herbal remedies.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01056783


Locations
Switzerland
Swiss EoE Research Group
Olten, Switzerland, CH-4600
Sponsors and Collaborators
Oxagen Ltd
Investigators
Principal Investigator: Alex Straumann, Dr Swiss EoE Research Group
  More Information

Responsible Party: Oxagen Ltd
ClinicalTrials.gov Identifier: NCT01056783     History of Changes
Other Study ID Numbers: OC000459/013/09
First Submitted: January 25, 2010
First Posted: January 26, 2010
Last Update Posted: January 5, 2012
Last Verified: January 2012

Keywords provided by Oxagen Ltd:
EoE

Additional relevant MeSH terms:
Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Indoleacetic Acids
Plant Growth Regulators
Growth Substances
Physiological Effects of Drugs