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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.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT01810185
Date of registration: 11/03/2013
Prospective Registration: Yes
Primary sponsor: Santa Barbara Cottage Hospital
Public title: Low Dose Naltrexone in Symptomatic Inflammatory Bowel Disease
Scientific title: Low Dose Naltrexone in Symptomatic Inflammatory Bowel Disease
Date of first enrolment: March 2013
Target sample size: 0
Recruitment status: Withdrawn
URL:  http://clinicaltrials.gov/show/NCT01810185
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment  
Phase:  Phase 2
Countries of recruitment
United States
Contacts
Name:     Erick J Imbertson, M.D.
Address: 
Telephone:
Email:
Affiliation:  Santa Barabara Cottage Hospital
Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Crohn's Disease
Inflammatory Bowel Disease
Ulcerative Colitis
Intervention(s)
Drug: Low dose naltrexone
Drug: Placebo
Primary Outcome(s)
An increase in the subjects inflammatory bowel disease questionnaire score [Time Frame: 6 weeks, 12 weeks, and 6 months]
Secondary Outcome(s)
Secondary ID(s)
LDN in IBD
SBCH- LDN in IBD
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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