The Efficacy of Low Dose Naltrexone Therapy in Children With Crohn's Disease
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal, Crohns Disease |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 6 - 17 |
| Updated: | 9/8/2018 |
| Start Date: | July 2008 |
| End Date: | August 2010 |
It is hypothesized that oral naltrexone will improve inflammation of the bowel by increasing
endogenous enkephalin levels in subjects with active Crohn's disease. This is especially
important in children who often are suffering from nutritional deprivation which retards
their growth.
The key objectives are to:
1. Evaluate the effects of low dose naltrexone in children with Crohn's Disease by using
the Pediatric Crohn's Disease Activity Index (PCDAI), plasma inflammatory markers,
weight, and pediatric quality of life survey.
2. To determine the safety and toxicity of low dose naltrexone in pediatric subjects with
active Crohn's Disease.
3. Assess the potential mechanism by which naltrexone exerts its action by measuring plasma
opioid (enkephalin and endorphin levels) and proinflammatory cytokines.
endogenous enkephalin levels in subjects with active Crohn's disease. This is especially
important in children who often are suffering from nutritional deprivation which retards
their growth.
The key objectives are to:
1. Evaluate the effects of low dose naltrexone in children with Crohn's Disease by using
the Pediatric Crohn's Disease Activity Index (PCDAI), plasma inflammatory markers,
weight, and pediatric quality of life survey.
2. To determine the safety and toxicity of low dose naltrexone in pediatric subjects with
active Crohn's Disease.
3. Assess the potential mechanism by which naltrexone exerts its action by measuring plasma
opioid (enkephalin and endorphin levels) and proinflammatory cytokines.
The present proposal is designed as double-blinded placebo controlled study involving 30
children between 6-17 years of age with active Crohn's disease. Children will be treated with
either naltrexone or placebo for the first 8 weeks then all subjects will receive active
naltrexone drug the last 8 weeks. A one month follow-up appointment will be scheduled 4-weeks
after completion of the active drug for safety and to assess Crohn's activity. Low dose
naltrexone (LDN) will be dispensed in either capsules at a dose of 4.5 mg for those ages 10
years or older and in liquid form at 0.1 mg/kg for those under age of 10 or less than 45 kg.
Half of the subjects in the first 8 weeks will be randomized to placebo which will be either
capsules filled with avicel (see section 6.0) or diluent (flavored water) if in liquid form.
Children are eligible who are not of child-bearing potential or are using two means of
effective birth control, have a Pediatric Crohn's Disease Activity Index (PCDAI) of at least
31 points, and have the confirmed diagnosis of Crohn's disease by either endoscopic or
radiographic tests.
children between 6-17 years of age with active Crohn's disease. Children will be treated with
either naltrexone or placebo for the first 8 weeks then all subjects will receive active
naltrexone drug the last 8 weeks. A one month follow-up appointment will be scheduled 4-weeks
after completion of the active drug for safety and to assess Crohn's activity. Low dose
naltrexone (LDN) will be dispensed in either capsules at a dose of 4.5 mg for those ages 10
years or older and in liquid form at 0.1 mg/kg for those under age of 10 or less than 45 kg.
Half of the subjects in the first 8 weeks will be randomized to placebo which will be either
capsules filled with avicel (see section 6.0) or diluent (flavored water) if in liquid form.
Children are eligible who are not of child-bearing potential or are using two means of
effective birth control, have a Pediatric Crohn's Disease Activity Index (PCDAI) of at least
31 points, and have the confirmed diagnosis of Crohn's disease by either endoscopic or
radiographic tests.
Inclusion Criteria:
- All subjects must give written informed consent by parent or guardian
- Male or female subjects, > 6 - 17 years
- Patients must have endoscopic or radiographic confirmed Crohn's Disease.
- Patients must have a Pediatric Crohn's Disease Activity Index (PCDAI) of at least 31.
Exclusion Criteria:
- Adolescent women of childbearing potential and / or sexually active unless surgically
sterile or using adequate contraception (either IUD, oral or deport contraceptive, or
barrier plus spermicide), and willing and able to continue contraception for 3 months
after the completion of the study.
- Adolescent women who are pregnant or breastfeeding
- Subjects with an ostomy or ileocolic anastomosis from surgery as these operations
interfere with the PCDAI assessment
- Subjects taking tacrolimus, cyclosporin, mycophenolate, or anti-TNF-α therapy must be
discontinued 4 weeks prior to study initiation.
- Patients with abnormal liver function tests
- Prednisone greater than 10 mg or > 0.2 mg/kg orally
We found this trial at
1
site
Click here to add this to my saved trials
