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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01810185 |
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Date of registration:
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11/03/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Low Dose Naltrexone in Symptomatic Inflammatory Bowel Disease
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Scientific title:
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Low Dose Naltrexone in Symptomatic Inflammatory Bowel Disease |
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Date of first enrolment:
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March 2013 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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http://clinicaltrials.gov/show/NCT01810185 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Erick J Imbertson, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Santa Barabara Cottage Hospital |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Crohn's Disease
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Inflammatory Bowel Disease
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Ulcerative Colitis
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Intervention(s)
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Drug: Placebo
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Drug: Low dose naltrexone
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Primary Outcome(s)
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An increase in the subjects inflammatory bowel disease questionnaire score
[Time Frame: 6 weeks, 12 weeks, and 6 months]
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Secondary ID(s)
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SBCH- LDN in IBD
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LDN in IBD
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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