Status:
COMPLETED
The Effects of Naltrexone on Active Crohn's Disease
Lead Sponsor:
Milton S. Hershey Medical Center
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
The Broad Foundation
Conditions:
Inflammation
Crohn's Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 h...
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 ac...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00663117
Start Date
September 1 2006
End Date
October 1 2009
Last Update
October 2 2018
Active Locations (1)
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1
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States, 17033