- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00715117
The Efficacy of Low Dose Naltrexone Therapy in Children With Crohn's Disease (LDN-Ped)
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:
- 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.
- To determine the safety and toxicity of low dose naltrexone in pediatric subjects with active Crohn's Disease.
- Assess the potential mechanism by which naltrexone exerts its action by measuring plasma opioid (enkephalin and endorphin levels) and proinflammatory cytokines.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Pennsylvania
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Hershey, Pennsylvania, United States, 17033
- Penn State University Hershey Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Sugar pill
Subjects will receive placebo for for the first 8 weeks administered orally one time daily.
After 8 weeks placebo treated subjects are then crossed over to active drug naltrexone 0.1 mg/kg not to exceed 4.5 mg PO once daily for an additional 8 weeks.
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Placebo -Sugar pill or liquid identical to active drug in appearance and taste given by mouth at bedtime once daily
Other Names:
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Experimental: Naltrexone
Naltrexone 0.1 mg/kg (not to exceed 4.5mg) once a day orally either in capsules or liquid blinded for 8 weeks followed by open-labeled naltrexone for an additional 8 weeks.
Safety and toxicity will be compared to placebo.
Also change in Crohn's activity index scores of naltrexone to placebo are compared.
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Naltrexone 0.1 mg/kg (not to exceed 4.5mg) once a day orally for 16 weeks
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Patients Reporting Side Effects
Time Frame: 8 weeks or 16 weeks
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Using adverse events and laboratory values Safety & toxicity were evaluated between those on placebo for 8 weeks and those on naltrexone for either 8 or 16 weeks.
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8 weeks or 16 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pediatric Crohn's Disease Activity Index Score (PCDAI)
Time Frame: Pretreatment and 8 weeks
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Secondary outcome was efficacy on clinical activity. Mean pretreatment PCDAI scores in patients had moderate to severe disease activity at baseline were compared between those who received placebo for 8 weeks and those who received active experimental drug, naltrexone. The PCDAI score is a number unit that is calculated from symptoms scores by the subject over a 7-day period prior to the visit, laboratory values, height & weight, and physical exam findings. A score of 10 and under denotes "remission". Mild disease (score of 11-30); moderate disease (score of 31-45), a severe disease (scores greater than 45. A decline of 10 points or more is considered "response to therapy". The score can range from 0 to >60 Patient must have a PCDAI score of equal or greater than 30 to qualify for this study (i.e., moderate to severe disease). |
Pretreatment and 8 weeks
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Change in Quality of Life Scores From Baseline to After 8 Weeks of Naltrexone Therapy
Time Frame: 16 weeks
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IMPACT III was a pediatric Crohn's specific quality of life survey used in this study.
It examines five major categories influencing the quality of life in children with Crohn's disease including bowel symptoms, systemic symptoms, emotional well-being, social well-being, and body image perception.
The IMPACT-III uses 5-point Likert scale ranging from 1 to 5 for all answers.
The outcome score ranges from 35 to 175, with higher scores suggesting better quality of life.
So an increase in score denotes improved Quality of life.
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16 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jill P Smith, MD, Pennsylvania State University College of Medicine
Publications and helpful links
General Publications
- Smith JP, Stock H, Bingaman S, Mauger D, Rogosnitzky M, Zagon IS. Low-dose naltrexone therapy improves active Crohn's disease. Am J Gastroenterol. 2007 Apr;102(4):820-8. doi: 10.1111/j.1572-0241.2007.01045.x. Epub 2007 Jan 11.
- Smith JP, Bingaman SI, Ruggiero F, Mauger DT, Mukherjee A, McGovern CO, Zagon IS. Therapy with the opioid antagonist naltrexone promotes mucosal healing in active Crohn's disease: a randomized placebo-controlled trial. Dig Dis Sci. 2011 Jul;56(7):2088-97. doi: 10.1007/s10620-011-1653-7. Epub 2011 Mar 8.
- Smith JP, Field D, Bingaman SI, Evans R, Mauger DT. Safety and tolerability of low-dose naltrexone therapy in children with moderate to severe Crohn's disease: a pilot study. J Clin Gastroenterol. 2013 Apr;47(4):339-45. doi: 10.1097/MCG.0b013e3182702f2b.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PSU-IRB-27793
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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