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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 12 December 2020
Main ID:  NCT00663117
Date of registration: 18/04/2008
Prospective Registration: No
Primary sponsor: Milton S. Hershey Medical Center
Public title: The Effects of Naltrexone on Active Crohn's Disease LDN
Scientific title: The Effects of Naltrexone in Active Crohn's Disease
Date of first enrolment: September 2006
Target sample size: 40
Recruitment status: Completed
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 2
Countries of recruitment
United States
Name:     Jill P. Smith, M.D.
Affiliation:  Pennsylvania State University College of Medicine
Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: 75 Years
Gender: All
Health Condition(s) or Problem(s) studied
Crohn's Disease
Drug: Naltrexone-HCl
Drug: Placebo
Primary Outcome(s)
Percentage of Subjects Achieving a 70-point Decline in CDAI Scores (Crohn's Disease Activity Index) Scores; [Time Frame: 3 months]
Secondary Outcome(s)
Histology Inflammatory Score by Colon Biopsies [Time Frame: 12 weeks]
Percentage Change From Baseline of Quality of Life IBDQ (Inflammatory Bowel Disease Quality of Life Survey) [Time Frame: Between baseline and 3 months]
Percentage of Patients With a 5 Point Drop in CDEIS Score by Endoscopy [Time Frame: 12 weeks]
Secondary ID(s)
DK073614 l
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
The Broad Foundation
Ethics review
Results available: Yes
Date Posted: 17/05/2013
Date Completed:
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