Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effects of Naltrexone on Active Crohn's Disease (LDN)

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: NCT00663117
Recruitment Status : Completed
First Posted : April 22, 2008
Results First Posted : May 17, 2013
Last Update Posted : October 2, 2018
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
The Broad Foundation
Information provided by (Responsible Party):
Milton S. Hershey Medical Center

Tracking Information
First Submitted Date  ICMJE April 18, 2008
First Posted Date  ICMJE April 22, 2008
Results First Submitted Date  ICMJE November 30, 2012
Results First Posted Date  ICMJE May 17, 2013
Last Update Posted Date October 2, 2018
Study Start Date  ICMJE September 2006
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2013)
Percentage of Subjects Achieving a 70-point Decline in CDAI Scores (Crohn's Disease Activity Index) Scores; [ Time Frame: 3 months ]
The CDAI score is a number which consists of information collected from a 7-day diary from the patient regarding symptoms. It also includes objective information from the physical exam, weight and hemotocrit. Remission is considered a score of 150 or less. Active disease is considered 220 or greater. A response to therapy is considered a decline in the CDAI score of 70-points from baseline.
Original Primary Outcome Measures  ICMJE
 (submitted: April 18, 2008)
Effects of naltrexone on inflammation of the bowel based upon the following: CDAI scores (Crohn's disease activity index) scores; C-Reactive Protein and ESR; Endoscopic appearance on colonoscopy; Histology biopsies [ Time Frame: 7 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2013)
  • Percentage Change From Baseline of Quality of Life IBDQ (Inflammatory Bowel Disease Quality of Life Survey) [ Time Frame: Between baseline and 3 months ]
    IBDQ (Inflammatory bowel Disease questionnaire) contains questions about health ranging from a score of poor (i.e., 32) to excellent (i.e., 224) an increase from baseline indicates improvement in quality of life.
  • Percentage of Patients With a 5 Point Drop in CDEIS Score by Endoscopy [ Time Frame: 12 weeks ]
    A secondary outcome was the appearance of the colonic mucosa on endoscopy using the Crohn's Disease Endoscopic Index of Severity (CDEIS) score described by Mary et al. Gut 1989;30:983-989.This score ranges from 0-44 based upon the extent and severity of inflammation and ulcers seen during endoscopy of the colon. A response is a drop of > 5 points from baseline. Endoscopic remission is a score of < 6 and Complete endoscopic remission is a score of > 3.
  • Histology Inflammatory Score by Colon Biopsies [ Time Frame: 12 weeks ]
    Histology scores to assess microscopic inflammation and structural architecture were determined at baseline and after 12 weeks of either naltrexone therapy or placebo by mucosal biopsy samples obtained during colonoscopies.The pathology specimens were reviewed and scored by a Pathologist blinded to the treatment. The mean scores at baseline were the same between both groups.Differences between naltrexone and placebo treated subjects was assessed.The range in scores could be 0-25, with 0 representing no inflammation and 25 being maximum or severe inflammation..
Original Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2008)
  • Quality of life: based upon 2 QOL surveys [ Time Frame: seven months ]
  • Effects of naltrexone on remission of Crohn's disease [ Time Frame: seven months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of Naltrexone on Active Crohn's Disease
Official Title  ICMJE The Effects of Naltrexone in Active Crohn's Disease
Brief Summary

It is hypothesized that the opioid antagonist naltrexone will improve inflammation of the bowel and quality of life in subjects with active Crohn's disease compared to placebo. In order to test this hypothesis the following specific aims are proposed:

  1. Evaluate the effects of low dose naltrexone compared to placebo on the activity of Crohn's disease by the following end points: Crohn's Disease Activity Index (CDAI), pain assessment, laboratory values (CRP and ESR), endoscopic appearance, histology, and quality of life surveys;
  2. Examine the effects of naltrexone given over 3 months compared to 6 months for durability of response;
  3. Determine the safety and toxicity of low dose naltrexone in subjects with active Crohn's disease, and
  4. Study the mechanism by which naltrexone exerts its effect by measuring plasma enkephalin levels of subjects on therapy.

Purpose statement: The purpose of this study is to evaluate the effects of low dose naltrexone in a blinded placebo controlled study to determine the safety and efficacy of this compound in those with active Crohn's disease.

Detailed Description Study design : The study is designed as a double-blind placebo controlled study for 3 months followed by a pseudo cross-over such that all subjects receiving placebo the first 3 months will receive active drug the second 3 months and all receiving naltrexone the first 3 months remain on the drug the last 3 months of this 6 month study.
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
  • Inflammation
  • Crohn's Disease
Intervention  ICMJE
  • Drug: Naltrexone-HCl
    naltrexone 4.5 mg
    Other Names:
    • LDN
    • Revia
  • Drug: Placebo
    Placebo
    Other Name: sugar pill
Study Arms  ICMJE
  • Placebo Comparator: Placebo, Sugar pill
    placebo for 3 months blinded then followed by an open-labelled study and all are treated with naltrexone 4.5 mg for 3 additional months
    Interventions:
    • Drug: Naltrexone-HCl
    • Drug: Placebo
  • Active Comparator: Naltrexone-HCl
    Subjects are treated in a blinded fashion for 3 months with naltrexone 4.5 mg po for active Crohn's disease followed an open-labelled study where naltrexone is given an additional 3 months at 4.5 mg po; hence the total treatment interval in this arm is 6 months. The response to the intervention administered is measured in the activity index and mucosal healing by colonoscopy.
    Intervention: Drug: Naltrexone-HCl
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: April 18, 2008)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All subjects must give written informed consent
  • Male or female subjects, > 18 years
  • Patients must have endoscopic, histologic, or radiographic confirmed Crohn's Disease.
  • Patients must have a Crohn's Disease Activity Index (CDAI) of at least 220 at Baseline
  • Stable doses of medications for Crohn's disease over proceeding 4 weeks (for aminosalicylates and steroids: prednisone of 10mg or less daily and Entocort 3 mg/ day are allowed), and 12 weeks for azathioprine or 6-mercaptopurine.)

Exclusion Criteria:

  • Subjects with ostomies or ileorectal anastomosis from prior surgical colectomy.
  • Subjects who received infliximab (Remicade) within 8 weeks of study screening or humira for 4 weeks.
  • Subjects requiring steroids either intravenously or prednisone >10mg /day or Entocort > 3 mg daily.
  • Subjects with short-bowel syndrome.
  • Abnormal liver enzymes at screening visit or known hepatitis or cirrhosis
  • Hemoglobin less than 10.
  • Subjects with cancer (other than skin cancer) in past 5 years.
  • Women of childbearing potential 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.
  • Women who are pregnant or breastfeeding
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
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 NCT00663117
Other Study ID Numbers  ICMJE DK073614 l
1R03DK073614 ( U.S. NIH Grant/Contract )
IBD-0180R ( Other Grant/Funding Number: Broad Medical Research Program )
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
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • The Broad Foundation
Investigators  ICMJE
Principal Investigator: Jill P. Smith, M.D. 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