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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
  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

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 ] [ 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Eosinophilic Esophagitis
Esophagitis
Digestive System Diseases
Eosinophilia
Esophageal Diseases
Gastroenteritis
Gastrointestinal Diseases
Hematologic Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Leukocyte Disorders

ClinicalTrials.gov processed this record on November 25, 2014