Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Milton S. Hershey Medical Center
With
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
The Broad Foundation
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.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.)
You may not be if
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
Clareo Health | The Effects of Naltrexone on Active Crohn's Disease
