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

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

Ohkubo Hidenori

Yokohama City University Hospital

3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan

ohkuboh@yokohama-cu.ac.jp

Ohkubo Hidenori

Yokohama City University Hospital

3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan

+81-45-787-2640

ohkuboh@yokohama-cu.ac.jp

Not Recruiting

Oct. 01, 2019

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

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.

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

Both

Chronic Intestinal Pseudo-obstruction

Two tablets of the investigational product per dosing (400 mg of rifaximin) or the placebo are orally administered 3 times daily for 4 weeks.

CIPO, abdominal bloating

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

1) Changes of the improvement ratio (%) in abdominal bloating score in Global Symptomatic Score (GSS)
2) Changes of the improvement ratio (%) in gastrointestinal symptoms score
3) Changes of abdominal bloating score in Global Symptomatic Score (GSS)
4) Changes of each score in Global Symptomatic Score other than abdominal bloating score of the following symptoms are assessed; (a. diarrhea, b. epigastric pain/ discomfort, c. pain in the lower quadrant/discomfort, d. tenderness, e. nausea, f. vomiting).
5) Changes of each score in Global Symptomatic Score other than abdominal bloating score of the following symptoms are assessed;a. diarrhea, b. epigastric pain/discomfort, c. abdominal distention, d. pain in the lower quadrant/discomfort, e. tenderness, f. nausea, g. vomiting)
6) Changes of the "good" ratio (%) in gastrointestinal symptoms score
7) Changes of the improvement ratio (%) in General health condition (symptoms) score
8) Changes of the "good" ratio (%) in General health condition (symptoms) score
9) Changes of the improvement ratio (%) in patient satisfaction score
10) Changes of Short Form (SF)-8 health survey score
11) Changes of small intestinal volume measured by abdominal CT scan
12) Changes from baseline of nutritional assessment parameters
Other Pre-specified Outcome Measures:
1) Small intestinal bacterial overgrowth (SIBO) in a glucose-hydrogen breath test
2) Changes of Serum endotoxin activity
3) Fecal test (intestinal flora)
Safety outcines Measures
1) Incidence of adverse events
2) Changes from baseline of laboratory test parameters

+81-45-787-2714

Aug. 21, 2019

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