The Effects of Naltrexone on Active Crohn's Disease - Full Text View

Sponsors and Collaborators:	Penn State University National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) The Broad Foundation
Information provided by:	Penn State University
ClinicalTrials.gov Identifier:	NCT00663117

Purpose

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:

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;
Examine the effects of naltrexone given over 3 months compared to 6 months for durability of response;
Determine the safety and toxicity of low dose naltrexone in subjects with active Crohn's disease, and
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.

Condition	Intervention	Phase
Inflammation	Drug: Naltrexone Drug: Placebo	Phase II

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

Drug Information available for: Naltrexone Naltrexone hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	The Effects of Naltrexone in Active Crohn's Disease

Further study details as provided by Penn State University:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quality of life: based upon 2 QOL surveys [ Time Frame: seven months ] [ Designated as safety issue: Yes ]
Effects of naltrexone on remission of Crohn's disease [ Time Frame: seven months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	October 2006
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Placebo Comparator Subjects will receive placebo for 3 months then be crossed over to active drug for an additional 3 months	Drug: Placebo Placebo
B: Active Comparator Group 2 will receive naltrexone 4.5 mg by mouth once a day for 6 months	Drug: Naltrexone naltrexone 4.5 mg

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00663117

Contacts

Contact: Sandra I Bingaman, RN	1 (800) 243-1455 ext 8108	sbingaman@psu.edu
Contact: Jill P Smith, MD	717-531-5519

Locations

United States, Pennsylvania
Penn State Hershey Medical Center	Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Sandra I Bingaman, RN 800-243-1455 ext 8108 sbingaman@psu.edu
Contact: Jill P Smith, MD 717-531-5519
Principal Investigator: Jill P. Smith, M.D.
Sub-Investigator: Ian S. Zagon, Ph.D.
Sub-Investigator: Francessca Ruggiero, M.D.
Sub-Investigator: David T. Mauger, Ph.D.

Sponsors and Collaborators

Penn State University

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

The Broad Foundation

Investigators

Principal Investigator:

Jill P. Smith, M.D.

Pennsylvania State University College of Medicine

More Information

Penn State Hershey Clinical Trials Website 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.

Responsible Party:	PennState University ( Jill P. Smith, MD )
Study ID Numbers:	DK073614 l, NIH 1 R03DK073614 l, IBD-0180R
Study First Received:	April 18, 2008
Last Updated:	July 31, 2008
ClinicalTrials.gov Identifier:	NCT00663117
Health Authority:	United States: Food and Drug Administration

Keywords provided by Penn State University:

naltrexone
LDN
IBD
Inflammatory bowel disease

Study placed in the following topic categories:

Digestive System Diseases
Gastrointestinal Diseases
Naltrexone
Crohn Disease

Inflammatory Bowel Diseases
Gastroenteritis
Intestinal Diseases
Inflammation

Additional relevant MeSH terms:

Pathologic Processes
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs

Narcotic Antagonists
Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009