Overview

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

Status:
Active, not recruiting
Trial end date:
2022-01-01
Target enrollment:
0
Participant gender:
All
Summary
The objective of the study is to investigate efficacy and safety of rifaximin (L-105) in patients with chronic idiopathic intestinal pseudo-obstruction(CIIPO) or patients with chronic intestinal pseudo-obstruction (CIPO), secondary to systemic scleroderma
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Yokohama City University
Collaborator:
ASKA Pharmaceutical Co., Ltd.
Treatments:
Rifaximin
Criteria
Inclusion Criteria:

- Outpatients aged ≥20 and <75 on the day of informed consent (IC)

- Patients with CIIPO (designated intractable disease 99) at enrollment, satisfying all
the criteria specified in (1) to (7) of the CIIPO Diagnostic Criteria issued in 2014
by the MHLW Research Group, or patients with CIPO, secondary to systemic scleroderma,
satisfying all the same criteria specified in (1) to (6)

- Patients' levels of abdominal bloating symptoms, 4 scales of GSS, should be score 2 or
3 at the time of IC acquisition and enrollment.

Exclusion Criteria:

- Patients with malignant diseases (excluding those whose symptoms are stable and who do
not require aggressive treatments such as chemotherapy and/or surgical therapy)

- Patients with psychiatric diseases (excluding those whose symptoms are stable, and the
investigator or coinvestigator concludes that efficacy of the patient can be assessed
without any issue)

- Patients with severe diabetes within 5 weeks before enrollment (HbA1c >10%)

- Patients who have already had gastrostomy (including percutaneousendoscopic gastro
-jejunostomy, PEG-J), enterostomy, or colostomy

- Patients who underwent intestinal decompression therapy not associated with surgical
procedures (trans-nasal ileus tube) within 4weeks before enrollment

- Patients who used antimicrobials, antiparasitics or antifungals (excluding topical
use) within 4 weeks before enrollment

- Patients who have changed the doses of the following concomitantly administered drugs
within 4 weeks before enrollment: mosapride, daikenchuto, metoclopramide, acotiamide

- Patients with severe hepatic disorders within 5 weeks before enrollment (who meet
either one of the following criteria: AST≥ 5 x the upper limit of the common reference
value specified in the Japanese Committee for Clinical Laboratory Standards (JCCLS),
ALT≥ 5 x the upper limit of the common reference value specified in JCCLS, total
bilirubin ≥ 3 x the upper limit of the common reference value specified in JCCLS,
decompensated hematic cirrhosis, or jaundice)

- Patients who are pregnant, breastfeeding, possibly pregnant, or those who wish to
become pregnant

- Patients with a previous history of hypersensitivity to any investigational product
ingredients

- Patients with active tuberculosis

- Patients who participated in other clinical trial (including a trial with an
investigational product) within 12 weeks before this enrollment and who received an
intervention with a test drug

- Other patients whose participation in the trial is concluded to be inappropriate by
the investigator or coinvestigator