NL-OMON21939RecruitingNot Applicable
ow Dose Naltrexone for the induction of remission in patients with mild to moderate Crohn’s Diseasethat failed conventional treatment
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- ZonMW
- Enrollment
- 122
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
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.
Investigators
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