Skip to main content
OpenTrials
Completed

NCT Number: NCT01056783

Proof of Concept Study of OC000459 in 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Swiss EoE Research Group

Olten, CH-4600, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

OC000459

Drug

OC000459 100mg, twice daily, tablet

Placebo

Drug

Placebo tablets to match OC000459 tablets, twice daily

Primary outcomes

  1. Effect of OC000459 on eosinophil load of the esophageal tissue

    Time frame: 8 weeks

Secondary outcomes

  1. Effect of OC000459 on clinical manifestations of EoE

    Time frame: 8 weeks

  2. Effect of OC000459 on endoscopic alterations

    Time frame: 8 weeks

  3. Effect of OC000459 on EoE related blood and tissue biomarkers

    Time frame: 8 weeks

  4. Safety and tolerability of OC000459 in patients with active EoE

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Oxagen Ltd

Industry

Registry information

Official study title

A Randomized, Placebo-controlled, Double-blind, Single-centre Proof-of-concept Study of OC000459 in Adult Patients With Active Eosinophilic Esophagitis

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jan 26, 2010
Registry last updated
Jan 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.