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Clinical Trials/NL-OMON21939
NL-OMON21939
Recruiting
Not Applicable

ow Dose Naltrexone for the induction of remission in patients with mild to moderate Crohn’s Diseasethat failed conventional treatment

ZonMW0 sites122 target enrollmentTBD
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
ZonMW
Enrollment
122
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
ZonMW

Eligibility Criteria

Inclusion Criteria

  • •Age 18 or older; must have the ability to understand and sign a written ICF, which must be obtained prior to initiation of study procedures.
  • •\- Diagnosis of Crohn’s disease \=3 months before screening.
  • •\- Objective evidence of inflammation at baseline as defined by endoscopy with mucosal ulcers in the ileum or colon or both, and a SES\-CD score of 3\-15\.
  • •\- Concurrent therapies with stable doses of azathioprine, mercaptopurine, MTX or steroids (prednisolone \=30 mg/dl or budesonide \=9 mg per day) are permitted. Tapering of corticosteroids is mandatory.

Exclusion Criteria

  • •\- Current use of i.v. corticosteroids.
  • •\- Imminent need for in\-hospital treatment.
  • •\- Pregnancy or lactation.
  • •\- Previous or current treatment with investigational drug; current or past treatment within 6 months prior to randomization with a biological agent.
  • •\- Stool sample positive for Clostridium difficile (C. diff) toxin, pathogenic Escherichia coli (E. coli), Salmonella species (spp), Shigella spp, Campylobacter spp, or Yersinia spp.
  • •\- Other significant illnesses that may interfere with the study, stricture causing obstructive symptoms, or fistulising disease complicated by infection,
  • •\- Opiates use or drugs and/or alcohol abuse.
  • •\- Concomitant use of TNA alpha antagonist, Integrin antagonist, Interleukin antagonist, Cyclosporine, thalidomide, tacrolimus and any JAK inhibitors. Wash out period mandatory.

Outcomes

Primary Outcomes

Not specified

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