Efficacy Evaluation of Lubiprostone on Non-Alcoholic Fatty Liver Disease (NAFLD)wih constipation: LUBIPRONE, Proof of Concept(POC) Study.

Not Applicable

• Conditions: on-Alcoholic Fatty Liver Disease (NAFLD) in Constipated Patients

• Registration Number: JPRN-UMIN000026635
• Lead Sponsor: Yokohama University School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-22
• Study Completion: 2018-10-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

1)Patients with any change to their oral medications within 3 months before informed consent 2)Patients with any contraindications listed on the package insert for lubiprostone or with a history of hypersensitivity to any ingredients of lubiprostone 3)Patients with any other concurrent liver disease, such as hepatitis C, hepatitis B, or autoimmune hepatitis 4)Patients with concurrent or past history of any serious cardiac, vascular, hematological, respiratory, hepatic, renal, gastrointestinal, or neuropsychiatry disease 5)Patients with drug-induced, symptomatic NAFLD 6)Patients who participated in any other clinical study and received study treatment within 1 month before the start of this research (counted from the first day of study medication) 7)Patients with diabetes mellitus being treated with insulin injections 8)Patients with a history of abdominal or gastrointestinal surgery, with the exception of appendicitis 9)Breastfeeding women, or women with possible pregnancy 10)Other patients who are inappropriate as participants in this research in the opinion of the principal investigator etc.

Study & Design

• Study Type: Interventional
• Study Design: Not specified