A preliminary study of Low Dose Naltrexone for the induction of remission in patients with mild to moderate Crohn’s Disease that failed conventional treatment: The LDN Crohn study. - The LDN Crohn study

ErasmusMC0 个研究点目标入组 122 人开始时间: 2019年10月8日最近更新: 2024年5月27日

试验速览

暂无简介。

•Age 18 or older; must have the ability to understand and sign a written ICF, which must be obtained prior to initiation of study procedures.
•Diagnosis of Crohn’s disease =3 months before screening.
•Objective evidence of inflammation at baseline as defined by endoscopy with mucosal ulcers in the ileum or colon or both, and a SES-CD score of 3-15.
•Concurrent therapies with stable doses of azathioprine, mercaptopurine, MTX or steroids (prednisolone =30 mg/dl or budesonide =9 mg per day) are permitted. Tapering of corticosteroids is mandatory.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 105
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 17

•Current use of i.v. corticosteroids.
•Imminent need for in-hospital treatment.
•Pregnancy or lactation.
•Previous or current treatment with investigational drug; current or past treatment within 6 months prior to randomization with a biological agent.
•Stool sample positive for Clostridium difficile (C. diff) toxin, pathogenic Escherichia coli (E. coli), Salmonella species (spp), Shigella spp, Campylobacter spp, or Yersinia spp.
•Other significant illnesses that may interfere with the study, stricture causing obstructive symptoms, or fistulising disease complicated by infection,
•Opiates use or drugs and/or alcohol abuse.

发起方

ErasmusMC