Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Low Dose Naltrexone in Children With Crohn's Disease
NCT00715117Phase 2
Key facts
- Status
- Completed
- Start
- Jul 2008
- Primary completion
- May 2010
- Countries
- 1
- Sponsor
- Penn State Health Milton S. Hershey Medical Center
- Modality
- Small Molecules
- Drugs
- naltrexone
- Conditions
- Crohn's disease
01
Overview
Phase 2, randomised, double-blind trial in Crohn's disease comparing Placebo -> Naltrexone with Naltrexone -> Naltrexone (2 arms). Primary endpoint: Number of Patients Reporting Side Effects at 16 weeks. Started Jul 2008; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Placebo -> Naltrexone
Placebo for 8 weeks followed by Naltrexone for 8 weeks
Naltrexone -> Naltrexone
Naltrexone for 8 weeks followed by Naltrexone for 8 weeks
03
Who it enrols
Children 6-17 years with active Crohn's Disease (PCDAI >= 31). Excludes pregnant/breastfeeding, ostomy/ileocolic anastomosis, abnormal liver function, and recent use of tacrolimus, cyclosporin, mycophenolate, or anti-TNF-α therapy.
04
Endpoints
Primary
Number of Patients Reporting Side Effects
Secondary
Pediatric Crohn's Disease Activity Index Score
Change in Quality of Life Scores
Beyond the preview
Go deeper on NCT00715117.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT00715117.