A Phase 2 interventional study of Naltrexone-HCl and Placebo in Inflammation and Crohn's Disease, sponsored by Milton S. Hershey Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-10-02.
Sponsored by Milton S. Hershey Medical Center · Phase 2, Interventional, and Treatment
It is hypothesized that the opioid antagonist naltrexone will improve inflammation of the bowel and quality of life in subjects with active Crohn's disease compared to placebo. In order to test this hypothesis the following specific aims are proposed:
Purpose statement: The purpose of this study is to evaluate the effects of low dose naltrexone in a blinded placebo controlled study to determine the safety and efficacy of this compound in those with active Crohn's disease.
Study design : The study is designed as a double-blind placebo controlled study for 3 months followed by a pseudo cross-over such that all subjects receiving placebo the first 3 months will receive active drug the second 3 months and all receiving naltrexone the first 3 months remain on the drug the last 3 months of this 6 month study.
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's enrollment of 40 is below the median of 66 across 1,188 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →Milton S. Hershey Medical Center is the lead sponsor of 480 studies on the registry; 61 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 42 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
placebo for 3 months blinded then followed by an open-labelled study and all are treated with naltrexone 4.5 mg for 3 additional months
Drug: Naltrexone-HCl · Drug: Placebo
Subjects are treated in a blinded fashion for 3 months with naltrexone 4.5 mg po for active Crohn's disease followed an open-labelled study where naltrexone is given an additional 3 months at 4.5 mg po; hence the total treatment interval in this arm is 6 months. The response to the intervention administered is measured in the activity index and mucosal healing by colonoscopy.
Drug: Naltrexone-HCl
naltrexone 4.5 mg
Also known as: LDN, Revia
Placebo
Also known as: sugar pill
Percentage of Subjects Achieving a 70-point Decline in CDAI Scores (Crohn's Disease Activity Index) Scores;
The CDAI score is a number which consists of information collected from a 7-day diary from the patient regarding symptoms. It also includes objective information from the physical exam, weight and hemotocrit. Remission is considered a score of 150 or less. Active disease is considered 220 or greater. A response to therapy is considered a decline in the CDAI score of 70-points from baseline.
Time frame: 3 months
Percentage Change From Baseline of Quality of Life IBDQ (Inflammatory Bowel Disease Quality of Life Survey)
IBDQ (Inflammatory bowel Disease questionnaire) contains questions about health ranging from a score of poor (i.e., 32) to excellent (i.e., 224) an increase from baseline indicates improvement in quality of life.
Time frame: Between baseline and 3 months
Percentage of Patients With a 5 Point Drop in CDEIS Score by Endoscopy
A secondary outcome was the appearance of the colonic mucosa on endoscopy using the Crohn's Disease Endoscopic Index of Severity (CDEIS) score described by Mary et al. Gut 1989;30:983-989.This score ranges from 0-44 based upon the extent and severity of inflammation and ulcers seen during endoscopy of the colon. A response is a drop of \> 5 points from baseline. Endoscopic remission is a score of \< 6 and Complete endoscopic remission is a score of \> 3.
Time frame: 12 weeks
Histology Inflammatory Score by Colon Biopsies
Histology scores to assess microscopic inflammation and structural architecture were determined at baseline and after 12 weeks of either naltrexone therapy or placebo by mucosal biopsy samples obtained during colonoscopies.The pathology specimens were reviewed and scored by a Pathologist blinded to the treatment. The mean scores at baseline were the same between both groups.Differences between naltrexone and placebo treated subjects was assessed.The range in scores could be 0-25, with 0 representing no inflammation and 25 being maximum or severe inflammation..
Time frame: 12 weeks
This prospective, double blind, randomized placebo-controlled trial, undertaken between September 2006 and September 2009 at the Pennsylvania State University College of Medicine.
| Milestone | Placebo Then Naltrexone 4.5 mg Daily | Naltrexone Then Naltrexone 4.5 mg po Daily |
|---|---|---|
| Started | 20 | 20 |
| Completed | 19 | 20 |
| Not completed | 1 | 0 |
| Withdrew: Lack of efficacy | 1 | 0 |
The CDAI score is a number which consists of information collected from a 7-day diary from the patient regarding symptoms. It also includes objective information from the physical exam, weight and hemotocrit. Remission is considered a score of 150 or less. Active disease is considered 220 or greater. A response to therapy is considered a decline in the CDAI score of 70-points from baseline.
| percentage of pts | Placebo | Naltrexone 4.5 mg po Daily |
|---|---|---|
| Percentage of Subjects Achieving a 70-point Decline in CDAI Scores (Crohn's Disease Activity Index) Scores; | 40 | 88 |
IBDQ (Inflammatory bowel Disease questionnaire) contains questions about health ranging from a score of poor (i.e., 32) to excellent (i.e., 224) an increase from baseline indicates improvement in quality of life.
| percentage of change | Placebo | Naltrexone 4.5 mg po Daily |
|---|---|---|
| Percentage Change From Baseline of Quality of Life IBDQ (Inflammatory Bowel Disease Quality of Life Survey) | 18 ± 4 | 28 ± 5 |
A secondary outcome was the appearance of the colonic mucosa on endoscopy using the Crohn's Disease Endoscopic Index of Severity (CDEIS) score described by Mary et al. Gut 1989;30:983-989.This score ranges from 0-44 based upon the extent and severity of inflammation and ulcers seen during endoscopy of the colon. A response is a drop of \> 5 points from baseline. Endoscopic remission is a score of \< 6 and Complete endoscopic remission is a score of \> 3.
| percentage of patients | Placebo | Naltrexone 4.5 mg |
|---|---|---|
| Percentage of Patients With a 5 Point Drop in CDEIS Score by Endoscopy | 28 (0 to 100) | 78 ± .05 |
Histology scores to assess microscopic inflammation and structural architecture were determined at baseline and after 12 weeks of either naltrexone therapy or placebo by mucosal biopsy samples obtained during colonoscopies.The pathology specimens were reviewed and scored by a Pathologist blinded to the treatment. The mean scores at baseline were the same between both groups.Differences between naltrexone and placebo treated subjects was assessed.The range in scores could be 0-25, with 0 representing no inflammation and 25 being maximum or severe inflammation..
| units on a scale | Placebo | Naltrexone 4.5 mg po Daily |
|---|---|---|
| Histology Inflammatory Score by Colon Biopsies | 17.5 ± 4.5 | 5.2 ± 2.3 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 0/20 (0%) | 5/20 (25%) |
| Naltrexone 4.5 mg | — | 0/40 (0%) | 5/40 (12.5%) |
| Event | Placebo | Naltrexone 4.5 mg |
|---|---|---|
| insomniaNervous system disorders | 5/20 | 5/40 |
| FatigueGeneral disorders | 3/20 | 0/40 |
| Age, Categorical(Participants) | Placebo Daily | Naltrexone 4.5 mg po Daily | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 19 | 20 | 39 |
| >=65 years | 1 | 0 | 1 |
| Age, Continuous(years) | Placebo Daily | Naltrexone 4.5 mg po Daily | Total |
|---|---|---|---|
| Mean | 44.8 ± 2.8 | 40.5 ± 2.4 | 42.3 ± 2.5 |
| Sex: Female, Male(Participants) | Placebo Daily | Naltrexone 4.5 mg po Daily | Total |
|---|---|---|---|
| Female | 11 | 12 | 23 |
| Male | 9 | 8 | 17 |
| Region of Enrollment(participants) | Placebo Daily | Naltrexone 4.5 mg po Daily | Total |
|---|---|---|---|
| United States | 20 | 20 | 40 |
| Crohn's Disease Activity Index (CDAI) score(CDAI score) | Placebo Daily | Naltrexone 4.5 mg po Daily | Total |
|---|---|---|---|
| Mean | 327 ± 19 | 365 ± 16 | 346 ± 17.5 |
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Milton S. Hershey Medical Center