Low Dose Naltrexone in Symptomatic Inflammatory Bowel Disease
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|ClinicalTrials.gov Identifier: NCT01810185|
Recruitment Status : Withdrawn (Low patient enrollment)
First Posted : March 13, 2013
Last Update Posted : November 20, 2014
|Condition or disease||Intervention/treatment||Phase|
|Inflammatory Bowel Disease Crohn's Disease Ulcerative Colitis||Drug: Low dose naltrexone Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Low Dose Naltrexone in Symptomatic Inflammatory Bowel Disease|
|Study Start Date :||March 2013|
|Estimated Primary Completion Date :||March 2014|
|Estimated Study Completion Date :||March 2014|
Experimental: Low dose naltrexone
Subjects in this arm will recieve low dose naltrexone (4.5 mg) daily for 12 weeks.
Drug: Low dose naltrexone
4.5 mg daily for 12 weeeks
Other Name: Naltrexone
Placebo Comparator: Placebo
Subjects in this arm will recieve a placebo daily for 12 weeks.
- An increase in the subjects inflammatory bowel disease questionnaire score [ Time Frame: 6 weeks, 12 weeks, and 6 months ]Participants will fill-out a questionnaire called the IBDQ at enrollment, 6 weeks, 12 weeks, and 6 months after enrollment. The IBDQ is a validated instrument often used in routine care and studies of patients with IBD (Appendix E). The IBDQ measures the activity of IBD and quality of life. It includes 32 questions placed into 4 domains: bowel, social, emotional and systemic. Each question is ranked from 1-7, 1 being the poorest quality of life and 7 being the best quality of life8. A score of >170 means that a patient is clinically in remission and an increase in score between 16 and 32 are considered a meaningful improvement in symptoms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01810185
|United States, California|
|Santa Barbara Cottage Hospital|
|Santa Barbara, California, United States, 93105|
|Principal Investigator:||Erick J Imbertson, M.D.||Santa Barabara Cottage Hospital|