Efficacy and Safety of Rifaximin for Patients With Chronic Intestinal Pseudo-obstruction: a Phase 2 Trial
- Conditions
- Chronic Intestinal Pseudo-obstruction
- Interventions
- Drug: Placebo oral tablet
- Registration Number
- NCT04118699
- Lead Sponsor
- Yokohama City University
- Brief 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
- Detailed Description
This is a placebo-controlled, randomized, double-blind, parallel group, comparative study, when patients with chronic idiopathic intestinal pseudo-obstruction(CIIPO) or patients with chronic intestinal pseudo-obstruction (CIPO), secondary to the onset of systemic scleroderma, are administered rifaximin at 400 mg 3 times daily for 4 weeks. In addition, the time course of symptoms of the patients are to be confirmed for 8 weeks after the end of administration.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 12
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Rifaximin Rifaximin oral tablet Two tablets of the investigational product per dosing (400 mg of rifaximin) are orally administered 3 times daily for 4 weeks. Placebo Placebo oral tablet Two tablets of the placebo are orally administered 3 times daily for 4 weeks.
- Primary Outcome Measures
Name Time Method Improvement ratio (%) in abdominal bloating score in Global Symptomatic Score (GSS) at the end of administration (4 weeks) Abdominal bloating score in Global Symptomatic Score (GSS) is used. GSS is a 4-point Likert scale ranging from 0 (no symptom) to 3 (severe, incapacitating with inability to perform normal activities), with lower scores reflecting better symptoms. Score 0 or 1 is defined as improvement.
Improvement ratio (%) in Gastrointestinal (GI) symptoms score at the end of administration (4 weeks) Gastrointestinal score (GI score) is a 5-point Likert scale (0; greatly improved, 1; improved, 2; no change, 3; worsened, 4; severely worsened), with lower scores reflecting more improved symptoms. Score 0 or 1 is defined as improvement.
- Secondary Outcome Measures
Name Time Method Changes from baseline of cholinesterase Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration Cholinesterase is calculated for nutritional assessment
Changes from baseline of prealbumin (transthyretin) Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration Prealbumin (transthyretin) is calculated for nutritional assessment
Changes of Short Form (SF)-8 health survey score Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration SF-8(short form-8), a self-reporting health survey ranging from 8 to maximum of 42, with lower scores reflecting better conditions, is used.
Changes of the improvement ratio (%) in abdominal bloating score Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration Abdominal bloating score in Global Symptomatic Score (GSS) is used. GSS is a 4-point likert scale ranging from 0 (no symptom) to 3 (severe, incapacitating with inability to perform normal activities), with lower scores reflecting better symptoms. Score 0 or 1 is defined as improvement.
Changes of abdominal bloating score Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration Abdominal bloating score in Global Symptomatic Score (GSS) is used. GSS is a 4-point likert scale ranging from 0 (no symptom) to 3 (severe, incapacitating with inability to perform normal activities), with lower scores reflecting better symptoms.
Changes of the improvement ratio (%) in gastrointestinal symptoms score Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration Gastrointestinal score (GI score), a 5-point likert scale (0; greatly improved, 1; improved, 2; no change, 3; worsened, 4; severely worsened), with lower scores reflecting more improved symptoms, is used. Score 0 or 1 is defined as improvement.
Changes of the "good" ratio (%) in gastrointestinal symptoms score Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration Gastrointestinal score (GI score), 5-point likert scale (0; very good, 1; good, 2; average, 3; bad, 4; extremely bad), with lower scores reflecting better conditions, is used. Score 0 or 1 is defined as ''good''.
Changes of each score in Global Symptomatic Score other than abdominal bloating score Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration Global Symptomatic Score (GSS), a 4-point likert scale ranging from 0 (no symptom) to 3 (severe), 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).
Changes of total scores in Global Symptomatic Score Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration Sum of Global Symptomatic Score (GSS) of the following 7 symptoms, 0 to maximum of 21, are assessed; (a. diarrhea, b. epigastric pain/discomfort, c. abdominal distention, d. pain in the lower quadrant/discomfort, e. tenderness, f. nausea, g. vomiting).
Changes of the improvement ratio (%) in General health condition (symptoms) score Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration General health condition (symptoms) score, a 5-point likert scale (0; greatly improved, 1; improved, 2; no change, 3; worsened, 4; severely worsened), with lower scores reflecting more improved symptoms, is used. Score 0 or 1 is defined as improvement.
Changes of the "good" ratio (%) in General health condition (symptoms) score Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration General health condition (symptoms) score, 5-point scale (0; very good, 1; good, 2; average, 3; bad, 4; extremely bad), with lower scores reflecting better conditions, is used. Score 0 or 1 is defined as ''good''.
Patient satisfaction score At the end of the administration (4 weeks) % of the "satisfaction" ratio in patient satisfaction score
Small intestinal volume measured by abdominal CT scan Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration Changes of small intestinal volume measured by abdominal CT scan
Changes from baseline of serum albumin level Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration Serum albumin level is calculated for nutritional assessment
Changes from baseline of folic acid Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration Folic acid is calculated for nutritional assessment
Changes from baseline of vitamin B12 (cobalamin) Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration Vitamin B12 (cobalamin) is calculated for nutritional assessment
Changes from baseline of serum iron Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration Serum iron is calculated for nutritional assessment
Trial Locations
- Locations (1)
Yokohama city university
🇯🇵Yokohama, Kanagawa, Japan