Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Efficacy of Low Dose Naltrexone Therapy in Children With Crohn's Disease (LDN-Ped)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00715117
Recruitment Status : Completed
First Posted : July 15, 2008
Results First Posted : May 30, 2013
Last Update Posted : September 6, 2018
Sponsor:
Information provided by (Responsible Party):
Milton S. Hershey Medical Center

Tracking Information
First Submitted Date  ICMJE July 14, 2008
First Posted Date  ICMJE July 15, 2008
Results First Submitted Date  ICMJE August 4, 2011
Results First Posted Date  ICMJE May 30, 2013
Last Update Posted Date September 6, 2018
Study Start Date  ICMJE July 2008
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2013)
Number of Patients Reporting Side Effects [ Time Frame: 8 weeks or 16 weeks ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 14, 2008)
Pediatric Crohn's Disease Activity Index Score [ Time Frame: 5 months ]
Change History Complete list of historical versions of study NCT00715117 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2013)
  • Pediatric Crohn's Disease Activity Index Score (PCDAI) [ Time Frame: Pretreatment and 8 weeks ]
    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).
  • Change in Quality of Life Scores From Baseline to After 8 Weeks of Naltrexone Therapy [ Time Frame: 16 weeks ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2008)
IMPACT III which measures quality of life [ Time Frame: 5 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Efficacy of Low Dose Naltrexone Therapy in Children With Crohn's Disease
Official Title  ICMJE The Efficacy of Low Dose Naltrexone Therapy in Children With Crohn's Disease
Brief Summary

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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Crohn's Disease
Intervention  ICMJE
  • Drug: Naltrexone
    Naltrexone 0.1 mg/kg (not to exceed 4.5mg) once a day orally for 16 weeks
    Other Name: Revia, Vivitrol
  • Other: Placebo, sugar pill
    Placebo -Sugar pill or liquid identical to active drug in appearance and taste given by mouth at bedtime once daily
    Other Name: sugar pill
Study Arms  ICMJE
  • 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.
    Intervention: Other: Placebo, sugar pill
  • 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.
    Intervention: Drug: Naltrexone
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 18, 2011)
14
Original Estimated Enrollment  ICMJE
 (submitted: July 14, 2008)
30
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00715117
Other Study ID Numbers  ICMJE PSU-IRB-27793
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Milton S. Hershey Medical Center
Study Sponsor  ICMJE Milton S. Hershey Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jill P Smith, MD Pennsylvania State University College of Medicine
PRS Account Milton S. Hershey Medical Center
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP