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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 30 November 2020
Main ID:  EUCTR2019-000852-32-NL
Date of registration: 08/10/2019
Prospective Registration: Yes
Primary sponsor: ErasmusMC
Public title: A preliminary study of Low Dose Naltrexone for the induction of remission in patients with mild to moderate Crohn’s Disease that failed conventional treatment: The LDN Crohn study.
Scientific title: A preliminary study of Low Dose Naltrexone for the induction of remission in patients with mild to moderate Crohn’s Disease that failed conventional treatment: The LDN Crohn study. - The LDN Crohn study
Date of first enrolment: 30/01/2020
Target sample size: 122
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2019-000852-32
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries of recruitment
Netherlands
Contacts
Name: Coordinating/Subinvestigator   
Address:  Doctor Molewaterplein 40 3015 GD Rotterdam Netherlands
Telephone:
Email: e.paulides@erasmusmc.nl
Affiliation:  ErasmusMC
Name: Coordinating/Subinvestigator   
Address:  Doctor Molewaterplein 40 3015 GD Rotterdam Netherlands
Telephone:
Email: e.paulides@erasmusmc.nl
Affiliation:  ErasmusMC
Key inclusion & exclusion 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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 105
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 17

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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Inflammatory Bowel Disease, Crohn's disease
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Intervention(s)

Product Name: Naltrexone hydrochloride
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)
Main Objective: The aim of this preliminary study is to prospectively assess the efficacy of LDN as induction therapy in CD.
Primary end point(s): •Endoscopic remission at week 12 defined as SES-CD =4 and ulcerated surface subscore =1 in all five segments
Secondary Objective: •Proportion of patient in steroid free clinical remission defined as by an HBI score of =4 and complete tapering of systemic corticosteroids and endoscopic remission at week 12
•Response defined by a decrease in HBI of =3 points compared to baseline and endoscopic response defined as a reduction of SES-CD score by =50% vs baseline at week 12
•Changes in laboratory measures of inflammation (CRP, fecal calprotectin)
•Adverse events at every visit
•Quality of life, via the disease specific and validated sIBDQ
• Fatigue, via the FACIT-F and MFI
• Anxiety, Depression, Sleepdisturbance, via the PROMIS NIH
•Healthcare costs and utilization, via WPAI-UC and EQ-5D questionnaire
•PROM, via the IBD validated PRO2-tool
•Proportion of patients in corticosteroid free clinical remission
•Response at week 24 and 52
Timepoint(s) of evaluation of this end point: Week 12
Secondary Outcome(s)
Secondary end point(s): •Proportion of patient in steroid free clinical remission defined as by an HBI score of =4 and complete tapering of systemic corticosteroids and endoscopic remission at week 12
•Response defined by a decrease in HBI of =3 points compared to baseline and endoscopic response defined as a reduction of SES-CD score by =50% vs baseline at week 12
•Changes in laboratory measures of inflammation (CRP, fecal calprotectin)
•Adverse events at every visit
•Quality of life, via the disease specific and validated sIBDQ
• Fatigue, via the FACIT-F and MFI
• Anxiety, Depression, Sleepdisturbance, via the PROMIS NIH
•Healthcare costs and utilization, via WPAI-UC and EQ-5D questionnaire
•PROM, via the IBD validated PRO2-tool
•Proportion of patients in corticosteroid free clinical remission
•Response at week 24 and 52
Timepoint(s) of evaluation of this end point: week 2, 4, 6, 8, 12, 24, 36, 52
Secondary ID(s)
80-84800-98-82002
Source(s) of Monetary Support
ErasmusMC
ZonMw
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 30/01/2020
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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