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Proof of Concept Study of OC000459 in Eosinophilic Esophagitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Oxagen Ltd
ClinicalTrials.gov Identifier:
NCT01056783
First received: January 25, 2010
Last updated: January 4, 2012
Last verified: January 2012
History of Changes
  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
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)
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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Oxagen Ltd
ClinicalTrials.gov Identifier: NCT01056783     History of Changes
Other Study ID Numbers: OC000459/013/09
Study First Received: January 25, 2010
Last Updated: January 4, 2012
Health Authority: Switzerland: Swissmedic

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

ClinicalTrials.gov processed this record on May 21, 2013