Inflammatory Bowel Disease, Crohn's disease
Conditions
Interventions
Product Name: Naltrexone hydrochloride
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
ErasmusMC
Eligibility
Sex/Gender
All
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this preliminary study is to prospectively assess the efficacy of LDN as induction therapy in CD.;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 ;Primary end point(s): •Endoscopic remission at week 12 defined as SES-CD =4 and ulcerated surface subscore =1 in all five segments ;Timepoint(s) of evaluation of this end point: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Netherlands
Contacts
Public ContactCoordinating/Subinvestigator
ErasmusMC
Outcome results
None listed