ClinicalTrials.gg
Sign In
CompletedNCT01056783Updated Jan 5, 2012

Proof of Concept Study of OC000459 in Eosinophilic Esophagitis

A Phase 2 interventional study of OC000459 and Placebo in Eosinophilic Esophagitis, sponsored by Oxagen Ltd. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-01-05.

Sponsored by Oxagen Ltd · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Eosinophilic Esophagitis

Keywords

  • EoE
03

In context

Eosinophilic Esophagitis

238 studies on the registry are indexed under Eosinophilic Esophagitis; 52 are open to participants now.

This study's enrollment of 26 is below the median of 41 across 136 interventional studies indexed under Eosinophilic Esophagitis.

Browse Eosinophilic Esophagitis studies →

Lead sponsor

Oxagen Ltd is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
26 participants (actual)

Study arms

  • Experimental
    OC000459

    OC000459 100mg twice daily

    Drug: OC000459

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugOC000459

    OC000459 100mg, twice daily, tablet

  • DrugPlacebo

    Placebo tablets to match OC000459 tablets, twice daily

06

What researchers measure

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

07

Study locations

1 site
  • Swiss EoE Research Group
    Olten, CH-4600, Switzerland
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2010, a primary completion of Jun 2011 and a completion of Jun 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 25, 2010
First posted
Jan 26, 2010
Start
Aug 2010
Primary completionActual
Jun 2011
CompletionActual
Jun 2011
Last update
Jan 5, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 5, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01056783
Lead sponsor
Oxagen Ltd
Responsible party
Sponsor
First posted
Jan 26, 2010
Start date
Aug 2010
Primary completion
Jun 2011
Completion
Jun 2011
Last update
Jan 5, 2012

Study contacts

Alex Straumann, Dr
principal investigator · Swiss EoE Research Group

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Oc-459

Other studies in this condition

Eosinophilic Esophagitis →

Other studies from this sponsor

Oxagen Ltd

Start the discussion