Phase 2
N=40
The Effects of Naltrexone on Active Crohn's Disease
Inflammation · Crohn's Disease
Bottom Line
View on ClinicalTrials.gov: NCT00663117 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
May 2013
Primary outcome: Primary: Percentage of Subjects Achieving a 70-point Decline in CDAI Scores (Crohn's Disease Activity Index) Scores; — 40; 88 percentage of pts — p=0.009
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Naltrexone-HCl (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Milton S. Hershey Medical Center
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Achieving a 70-point Decline in CDAI Scores (Crohn's Disease Activity Index) Scores; |
40; 88 | 0.009 sig |
| SECONDARY Percentage Change From Baseline of Quality of Life IBDQ (Inflammatory Bowel Disease Quality of Life Survey) |
18; 28 | — |
| SECONDARY Percentage of Patients With a 5 Point Drop in CDEIS Score by Endoscopy |
28; 78 | 0.008 sig |
| SECONDARY Histology Inflammatory Score by Colon Biopsies |
17.5; 5.2 | 0.048 sig |
Summary
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:
1. Evaluate the effects of low dose naltrexone compared to placebo on the activity of Crohn's disease by the following end points: Crohn's Disease Activity Index (CDAI), pain assessment, laboratory values (CRP and ESR), endoscopic appearance, histology, and quality of life surveys;
2. Examine the effects of naltrexone given over 3 months compared to 6 months for durability of response;
3. Determine the safety and toxicity of low dose naltrexone in subjects with active Crohn's disease, and
4. Study the mechanism by which naltrexone exerts its effect by measuring plasma enkephalin levels of subjects on therapy.
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.
Eligibility Criteria
Inclusion Criteria
- All subjects must give written informed consent
- Male or female subjects, > 18 years
- Patients must have endoscopic, histologic, or radiographic confirmed Crohn's Disease.
- Patients must have a Crohn's Disease Activity Index (CDAI) of at least 220 at Baseline
- Stable doses of medications for Crohn's disease over proceeding 4 weeks (for aminosalicylates and steroids: prednisone of 10mg or less daily and Entocort 3 mg/ day are allowed), and 12 weeks for azathioprine or 6-mercaptopurine.)
Exclusion Criteria
- Subjects with ostomies or ileorectal anastomosis from prior surgical colectomy.
- Subjects who received infliximab (Remicade) within 8 weeks of study screening or humira for 4 weeks.
- Subjects requiring steroids either intravenously or prednisone >10mg /day or Entocort > 3 mg daily.
- Subjects with short-bowel syndrome.
- Abnormal liver enzymes at screening visit or known hepatitis or cirrhosis
- Hemoglobin less than 10.
- Subjects with cancer (other than skin cancer) in past 5 years.
- Women of childbearing potential unless surgically sterile or using adequate contraception (either IUD, oral or deport contraceptive, or barrier plus spermicide), and willing and able to continue contraception for 3 months after the completion of the study.
- Women who are pregnant or breastfeeding
Data sourced from ClinicalTrials.gov (NCT00663117). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.