Efficacy and Safety of Rifaximin for Patients With Chronic Intestinal Pseudo-obstruction: a Single Center, Randomized, Placebo Controlled, Double-blind Phase 2 Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Improvement ratio (%) in abdominal bloating score in Global Symptomatic Score (GSS)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Rifaximin
Two tablets of the investigational product per dosing (400 mg of rifaximin) are orally administered 3 times daily for 4 weeks.
干预措施: Rifaximin oral tablet (Drug)
Placebo
Two tablets of the placebo are orally administered 3 times daily for 4 weeks.
干预措施: Placebo oral tablet (Drug)
结局指标
主要结局
Improvement ratio (%) in abdominal bloating score in Global Symptomatic Score (GSS)
时间窗: 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
时间窗: 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.
次要结局
- Changes from baseline of cholinesterase(Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration)
- Changes from baseline of prealbumin (transthyretin)(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(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(Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration)
- Changes of abdominal bloating score(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(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(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(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(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(Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration)
- Patient satisfaction score(At the end of the administration (4 weeks))
- 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)
- 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 from baseline of serum albumin level(Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration)
- Changes from baseline of folic acid(Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration)
- Changes from baseline of vitamin B12 (cobalamin)(Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration)
- Changes from baseline of serum iron(Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration)