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Clinical Trials/NL-OMON52110
NL-OMON52110RecruitingPhase 3

A Prospective, Open-label Pilot Study to Evaluate Effector mechanisms of Hyperbaric Oxygen Therapy in Patients with Moderate-to-Severe Ulcerative Colitis: The PARADOX study - PARADOX study

Academisch Medisch Centrum0 sites24 target enrollmentStarted: TBDLast updated:
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Conditions

Trial Snapshot

Phase
Phase 3
Status
Recruiting
Enrollment
24
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
16 to 99 (—)

Inclusion Criteria

  • •In order to be eligible to participate in this study, a subject enrolled in the
  • •treatment groups must meet all of the following criteria:
  • •All patients in treatment groups:
  • •1. Documented diagnosis of UC >= 4 months prior to entry into the study,
  • •confirmed with endoscopy and pathology results available in the source documents
  • •2. Moderately to severely active UC as defined by a total MAYO score of >= 5 and
  • •a MAYO ES of >= 2 determined within 7 days of starting HBOT treatment
  • •3. Subjects must have failed or be intolerant (discontinued the medication due
  • •to an adverse event as determined by the investigator) of the following
  • •treatments:
  • •a. Oral corticosteroids
  • •b. Azathioprine or 6-mercaptopurine
  • •c. Anti-TNF therapy: infliximab, adalimumab or golimumab
  • •d. vedolizumab
  • •e. Current treatment with ustekinumab (or another p19 inhibitor in a clinical
  • •trial) or small-molecule therapy (e.g., tofacitinib)
  • •4. Current treatment with a stable dose of ustekinumab or tofacitinib (>12
  • •weeks of stable dose and interval of ustekinumab and >6 weeks of tofacitinib)
  • •5. Age 16 or older
  • •6. Approved for compassionate use of hyperbaric oxygen therapy by the treating
  • •physician and the health insurance company
  • •7. In the opinion of the investigator, the subject is capable of understanding
  • •and complying with protocol requirements.
  • •8. The subject signs and dates a written, informed consent form and any
  • •required privacy authorization prior to the initiation of any study procedures.
  • •9. Male or non-pregnant, non-lactating females. Females of child bearing
  • •potential must have a negative serum pregnancy test prior to randomization, and
  • •must use a hormonal (oral, implantable or injectable) or barrier method of
  • •birth control throughout week 26. Females unable to bear children must have
  • •documentation of such in the source records (i.e., tubal ligation,
  • •hysterectomy, or post-menopausal [defined as a minimum of one year since the
  • •last menstrual period]).

Exclusion Criteria

  • •A subject will not be eligible for participation in this study if any of the
  • •following criteria apply:
  • •1. Presence of indeterminate colitis, microscopic colitis, ischemic colitis,
  • •infectious colitis or clinical findings suggestive of Crohn*s disease
  • •2. Subjects without previous treatment for UC (i.e., treatment-naïve)
  • •3. Subjects at imminent need of surgery as judged by the treating clinician
  • •4. Subjects with evidence of colonic adenomas or dysplasia. However, subjects
  • •with prior history of adenomatous polyps will be eligible if the polyps have
  • •been completely removed and the subjects are free of polyps at baseline
  • •5. Subjects who have positive stool examinations for enteric pathogens
  • •(including Salmonella, Shigella, Yersinia, Campylobacter, C. difficile)
  • •detected by stool analysis within 2 weeks prior to enrollment pathogenic ova or
  • •parasites, at baseline
  • •6. Patients with an ostomy
  • •7. Unfit for hyperbaric oxygen therapy as assessed by the hyperbaric physician.
  • •8. Contra-indication for endoscopy
  • •9. Patients who received any investigational drug in the past 30 days or 5
  • •half-lives, whichever is longer
  • •10. A history of alcohol or illicit drug use that in the opinion of the
  • •principal investigator (PI) would interfere with study procedures
  • •11. Patients with psychiatric problems that in the opinion of the PI would
  • •interfere with study procedures
  • •12. Patients unable to attend all study visits
  • •13. Patients with a history of non-compliance with clinical study protocols

Investigators

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A Prospective, Open-label Pilot Study to... | Clinical Trial