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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

January 25, 2010
January 4, 2012
August 2010
June 2011   (final data collection date for primary outcome measure)
Effect of OC000459 on eosinophil load of the esophageal tissue [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01056783 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Proof of Concept Study of OC000459 in Eosinophilic Esophagitis
A Randomized, Placebo-controlled, Double-blind, Single-centre Proof-of-concept Study of OC000459 in Adult Patients With Active Eosinophilic Esophagitis

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Eosinophilic Esophagitis
  • Drug: OC000459
    OC000459 100mg, twice daily, tablet
  • Drug: Placebo
    Placebo tablets to match OC000459 tablets, twice daily
  • Experimental: OC000459
    OC000459 100mg twice daily
    Intervention: Drug: OC000459
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
June 2011
June 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01056783
OC000459/013/09
No
Oxagen Ltd
Oxagen Ltd
Not Provided
Principal Investigator: Alex Straumann, Dr Swiss EoE Research Group
Oxagen Ltd
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP