ow Dose Naltrexone for the induction of remission in patients with mild to moderate Crohn*s Disease that failed conventional treatment

Phase 2

• Conditions: Crohn's disease; inflammatory bowel disease; 10017969

• Registration Number: NL-OMON52463
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 122

Inclusion Criteria

• Age 18 or older; must have the ability to understand and sign a written ICF
• 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

Exclusion Criteria

• Current use of i.v. corticosteroids.
• Imminent need for in-hospital treatment.
• Pregnancy or lactation.
• Current treatment with investigational drug; current or past treatment within
3 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Endoscopic remission at week 12 defined as SES-CD <=2 and ulcerated surface<br /><br>subscore <=1 in all five segments.</p><br>