Trial record 3 of 1907 for:    Open Studies | "Intestinal Diseases"

Low Dose Naltrexone in Symptomatic Inflammatory Bowel Disease

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2013 by Santa Barbara Cottage Hospital
Sponsor:
Information provided by (Responsible Party):
Erick Jordan Imbertson, Santa Barbara Cottage Hospital
ClinicalTrials.gov Identifier:
NCT01810185
First received: March 11, 2013
Last updated: March 12, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Inflammatory Bowel Disease
Crohn's Disease
Ulcerative Colitis
Drug: Low dose naltrexone
Drug: Placebo
Phase 4

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
Official Title: Low Dose Naltrexone in Symptomatic Inflammatory Bowel Disease

Resource links provided by NLM:


Further study details as provided by Santa Barbara Cottage Hospital:

Primary Outcome Measures:
  • An increase in the subjects inflammatory bowel disease questionnaire score [ Time Frame: 6 weeks, 12 weeks, and 6 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 36
Study Start Date: March 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Placebo

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 with diagnosed with IBD and are symptomatic, defined by an inflammatory bowel disease questionnaire (IBDQ) score < 170. The subjects will be randomly assigned either placebo or LDN. They will take the IBDQ prior to starting the trial, 6 weeks, 12 weeks and 6 months after starting the medication. Participants have to remain on their current IBD regimen throughout the trial and cannot make any changes within 4 weeks of starting the trial. The investigators will have a safety phone call at 6 weeks and a follow up letter at 12 weeks after starting the trial. The participants will be given a card to keep with them with a phone number and email address if any adverse effects arise.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01810185

Contacts
Contact: Erick J Imbertson, M.D. (925)699-5083 eimbertson@yahoo.com
Contact: Samantha Yim, R.N. (805) 569-7461 syim@sbch.org

Locations
United States, California
Santa Barbara Cottage Hospital Not yet recruiting
Santa Barbara, California, United States, 93105
Contact: Erick J Imbertson, M.D.    925-699-5083    eimbertson@yahoo.com   
Principal Investigator: Erick J Imbertson, M.D.         
Sponsors and Collaborators
Santa Barbara Cottage Hospital
Investigators
Principal Investigator: Erick J Imbertson, M.D. Santa Barabara Cottage Hospital
  More Information

Publications:
Responsible Party: Erick Jordan Imbertson, M.D., Santa Barbara Cottage Hospital
ClinicalTrials.gov Identifier: NCT01810185     History of Changes
Other Study ID Numbers: LDN in IBD, SBCH- LDN in IBD
Study First Received: March 11, 2013
Last Updated: March 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Santa Barbara Cottage Hospital:
Inflammatory Bowel Disease
Crohn's disease
Ulcerative colitis
Naltrexone
Low Dose Naltrexone
Inflammatory Bowel Disease Questionnaire

Additional relevant MeSH terms:
Inflammatory Bowel Diseases
Intestinal Diseases
Colitis
Colitis, Ulcerative
Crohn Disease
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014