The Efficacy of Low Dose Naltrexone Therapy in Children With Crohn's Disease - Full Text View

Sponsor:	Penn State University
Information provided by:	Penn State University
ClinicalTrials.gov Identifier:	NCT00715117

Purpose

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.

Condition	Intervention	Phase
Crohn's Disease	Drug: Naltrexone Drug: Placebo and Naltrexone	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	The Efficacy of Low Dose Naltrexone Therapy in Children With Crohn's Disease

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

Drug Information available for: Naltrexone Naltrexone hydrochloride

U.S. FDA Resources

Further study details as provided by Penn State University:

Primary Outcome Measures:

Pediatric Crohn's Disease Activity Index Score [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]
Primary outcome was safety and toxicity

Secondary Outcome Measures:

IMPACT III which measures quality of life [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]
Secondary outcome was effects of naltrexone on PCDAI scores from baseline to end of 8-weeks of therapy.

Other secondary outcomes were quality of Life

Enrollment:	14
Study Start Date:	July 2008
Study Completion Date:	August 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: A Subjects will receive placebo for for the first 2 months then be crossed over to active drug for the last 2 months	Drug: Placebo and Naltrexone Subjects will receive placebo for for the first 2 months then be crossed over to active drug (Low Dose Naltrexone) for the last 2 months
Active Comparator: B Naltrexone 0.1 mg/kg (not to exceed 4.5mg) once a day for 4 months	Drug: Naltrexone Naltrexone 0.1 mg/kg (not to exceed 4.5mg) once a day for 4 months

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	6 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00715117

Locations

United States, Pennsylvania
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States, 17033

Sponsors and Collaborators

Penn State University

Investigators

Principal Investigator:

Jill P Smith, MD

Pennsylvania State University College of Medicine

More Information

Additional Information:

Penn State College of Medicine- Clinical Trials Office Site This link exits the ClinicalTrials.gov site

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. 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 Mar 8; [Epub ahead of print]

Responsible Party:	Jill P. Smith, MD, Penn State University
ClinicalTrials.gov Identifier:	NCT00715117 History of Changes
Other Study ID Numbers:	PSU-IRB-27793
Study First Received:	July 14, 2008
Last Updated:	May 18, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Penn State University:

children
pediatric
Crohn's Disease
naltrexone

LDN
IBD
Inflammatory bowel disease

Additional relevant MeSH terms:

Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Naltrexone

Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012