Efficacy and Safety of Rifaximin for Patients With Chronic Intestinal Pseudo-obstruction: a Phase 2 Trial

Phase 2

• Conditions: Chronic Intestinal Pseudo-obstruction; CIPO, abdominal bloating

• Registration Number: JPRN-jRCT2031190137
• Lead Sponsor: Ohkubo Hidenori

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-20
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1) Outpatients aged >=20 and < 75 years old on the day of informed consent (IC)
2) Patients with CIPO (designated intractable disease 99) at enrollment, meeting all the criteria specified in (1) to (7) of the CIPO Diagnostic Criteria issued in 2014 by the MHLW Research Group, or patients with CIPO, secondary to systemic scleroderma, meeting all the same criteria specified in (1) to (6)
3) Patients with GSS, a 4 Likert scale of abdominal bloating symptom level from 0 to 3, of 2 or 3 at the time of IC acquisition and enrollment.

Exclusion Criteria

1) Patients with malignant diseases (excluding those with stable symptoms and not requiring aggressive treatments such as chemotherapy and/or surgical therapy)
2) Patients with psychiatric diseases (excluding those with stable symptoms, and judged appropriate for efficacy assessment without any concern by the investigator or coinvestigators)
3) Patients with severe diabetes within 5 weeks before enrollment (HbA1c > 10%)
4) Patients with gastrostomy (including percutaneous sendoscopic gastro-jejunostomy, PEG-J), enterostomy, or colostomy for decompression
5) Patients who underwent intestinal decompression therapy not associated with surgical procedures (trans-nasal ileus tube) within 4weeks before enrollment
6) Patients who used antimicrobials, antiparasitics or antifungals (excluding topical use) within 4 weeks before enrollment
7) Patients who have changed the doses of the following concomitant medications within 4 weeks before enrollment: mosapride, daikenchuto, metoclopramide, acotiamide
8) Patients with severe liver dysfunction within 5 weeks before enrollment (who meet one or more of the following criteria: AST >= 5 times the upper limit of the common reference value specified in the Japanese Committee for Clinical Laboratory Standards (JCCLS), ALT>= 5 times the upper limit of the common reference value specified in JCCLS, total bilirubin >= 3 times the upper limit of the common reference value specified in JCCLS, decompensated liver cirrhosis, or jaundice)
9) Patients who are pregnant, breastfeeding, possibly pregnant, or with desire to get pregnant
10) Patients with a previous history of hypersensitivity to any investigational product ingredients
11) Patients with active tuberculosis
12) Patients who participated in other clinical trial (including a trial with an investigational product) and received an intervention with a test drug within 12 weeks before this enrollment
13) Patients judged inappropriate for enrollment in the trial by the investigator or coinvestigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified