Background: Mesenteric panniculitis is a chronic inflammatory and fibrotic disease characterized by mesenteric and pelvic infiltration with inflammatory cells, fibrosis, fat necrosis and calcification. Because of the rarity of mesenteric panniculitis, there is a lack of prospective studies on safe and appropriate treatments for this condition. Purpose and objectives: The purpose of the study is to evaluate naltrexone, an opioid antagonist with anti-inflammatory properties when administered in a low dose, as an effective therapy for symptomatic mesenteric panniculitis. Study design: Open label trial to assess the efficacy and safety of LDN in 25 patients with symptomatic mesenteric panniculitis. Study population: Patients with symptomatic mesenteric panniculitis who are at least 18 years of age with a diagnosis of mesenteric panniculitis verified within 12 months before study entry by CT scan or MRI of the abdomen and with a biopsy of the affected area which is negative for lymphoma or chronic infection, and with symptoms requiring treatment by their physician. Data analysis plan: A clinical response will be defined as diminution of symptoms as measured by the MPSAS. A biochemical response is defined as a reduction in the ESR or CRP levels. A quality of life response will be defined as an improvement in the four areas of the FANLTC score. Changes in MPSAS will be compared by Wilcoxon Rank Sum Test and Cross-table Analysis. A power calculation for the open label pilot study suggests that an 80% power is achieved if 50% of 25 patients that complete the study respond to treatment.

Public Health Relevance

Mesenteric panniculitis is a rare disease characterized by the development of a painful inflammatory mass in the abdomen. At the present time, treatments for this disease often involve medications with potentially severe side effects. Patients with mesenteric panniculitis will benefit greatly from this study of low dose naltrexone for their condition, not only because it will help to find a safer treatment, but because this study will also establish high quality methods to monitor the severity of the disease as well as the effects of treatment.

Agency
National Institute of Health (NIH)
Institute
Food and Drug Administration (FDA)
Type
Research Project (R01)
Project #
1R01FD005098-01A1
Application #
8949253
Study Section
Special Emphasis Panel (ZFD1-SRC (99))
Project Start
2015-09-10
Project End
2018-06-30
Budget Start
2015-09-10
Budget End
2016-06-30
Support Year
1
Fiscal Year
2015
Total Cost
Indirect Cost
Name
Northshore University Healthsystem
Department
Type
DUNS #
069490621
City
Evanston
State
IL
Country
United States
Zip Code
60201