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

• Register: ClinicalTrials.gov
• Last refreshed on: 28 June 2021
• Main ID: NCT04118699
• Date of registration: 23/09/2019
• Prospective Registration: Yes
• Primary sponsor: Yokohama City University
• Public title: Efficacy and Safety of Rifaximin for Patients With Chronic Intestinal Pseudo-obstruction: a Phase 2 Trial
• Scientific title: Efficacy and Safety of Rifaximin for Patients With Chronic Intestinal Pseudo-obstruction: a Single Center, Randomized, Placebo Controlled, Double-blind Phase 2 Trial
• Date of first enrolment: December 25, 2019
• Target sample size: 12
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT04118699
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Japan

Key inclusion & exclusion 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



Age minimum: 20 Years
Age maximum: 74 Years
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Intestinal Pseudo-obstruction

Intervention(s)

Drug: Rifaximin oral tablet

Drug: Placebo oral tablet

Primary Outcome(s)

Improvement ratio (%) in abdominal bloating score in Global Symptomatic Score (GSS) [Time Frame: at the end of administration (4 weeks)]

Improvement ratio (%) in Gastrointestinal (GI) symptoms score [Time Frame: at the end of administration (4 weeks)]

Secondary Outcome(s)

Changes from baseline of prealbumin (transthyretin) [Time Frame: Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration]

Changes of Short Form (SF)-8 health survey score [Time Frame: Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration]

Changes of the "good" ratio (%) in General health condition (symptoms) score [Time Frame: Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration]

Small intestinal volume measured by abdominal CT scan [Time Frame: Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration]

Changes from baseline of serum iron [Time Frame: Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration]

Changes from baseline of folic acid [Time Frame: Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration]

Changes of the "good" ratio (%) in gastrointestinal symptoms score [Time Frame: Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration]

Changes of the improvement ratio (%) in General health condition (symptoms) score [Time Frame: Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration]

Changes from baseline of cholinesterase [Time Frame: Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration]

Changes from baseline of serum albumin level [Time Frame: Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration]

Changes of each score in Global Symptomatic Score other than abdominal bloating score [Time Frame: Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration]

Changes of the improvement ratio (%) in gastrointestinal symptoms score [Time Frame: Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration]

Patient satisfaction score [Time Frame: At the end of the administration (4 weeks)]

Changes of abdominal bloating score [Time Frame: Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration]

Changes of the improvement ratio (%) in abdominal bloating score [Time Frame: Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration]

Changes from baseline of vitamin B12 (cobalamin) [Time Frame: Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration]

Changes of total scores in Global Symptomatic Score [Time Frame: Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration]

Secondary ID(s)

YCU19001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

ASKA Pharmaceutical Co., Ltd.