Status:
WITHDRAWN
Low Dose Naltrexone in Symptomatic Inflammatory Bowel Disease
Lead Sponsor:
Santa Barbara Cottage Hospital
Conditions:
Inflammatory Bowel Disease
Crohn's Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The investigators will be looking at the efficacy of the use of once daily use of low dose naltrexone (4.5mg) in subjects with symptomatic inflammatory bowel disease.
Detailed Description
The investigators will compare the use of daily low dose naltrexone (LDN) (4.5 mg) compared with placebo in subjects that have symptomatic inflammatory bowel disease (IBD). Our subjects will be those ...
Eligibility Criteria
Inclusion
- Patients with symptomatic Crohn's disease or ulcerative colitis (defined as a response to the Inflammatory Bowel Disease Questionnaire less than 170)
- Confirmed Crohn's disease or ulcerative colitis through radiographic, endoscopic and/or histologic criteria
- On a stable dose of medication for IBD (i.e. no change in medication within 4 weeks of study enrollment)
- Age 18 or older
Exclusion
- Patients on opioids or immodium within 7 days of starting the investigational therapy
- Women who are breastfeeding, pregnant, or plan on becoming pregnant within the next year
- Patients on Lomotil or opioid analgesics
- Patients already on low dose naltrexone
- Women of child bearing age not willing to use contraception or abstinence
- A history of the following diseases or procedures:
- Acute hepatitis
- Liver failure
- Ileoanal anastomosis
- Short bowel syndrome
- Abnormal liver enzymes
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01810185
Start Date
March 1 2013
End Date
March 1 2014
Last Update
November 20 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Santa Barbara Cottage Hospital
Santa Barbara, California, United States, 93105