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

NCT04118699 | Unknown Phase 2

• 1 other identifier: YCU19001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Intestinal Pseudo-obstruction

Keywords

Rifaximin; L-105; phase 2 trial; CIPO; small intestinal bacterial overgrowth; systemic scleroderma

Outcome Measures

Primary Outcomes (2)

• Improvement ratio (%) in abdominal bloating score in Global Symptomatic Score (GSS)

  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.

  at the end of administration (4 weeks)

• Improvement ratio (%) in Gastrointestinal (GI) symptoms score

  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.

  at the end of administration (4 weeks)

Secondary Outcomes (17)

• 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 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 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

Other Outcomes (12)

• Small intestinal bacterial overgrowth (SIBO) in a glucose-hydrogen breath test

  Before, 4 weeks after administration;and 8 weeks after the end of administration

• Changes of Serum endotoxin activity

  Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration

• Fecal test (intestinal flora)

  Before and 4 weeks after administration

Study Arms (2)

Rifaximin

EXPERIMENTAL

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

Drug: Rifaximin oral tablet

Placebo

PLACEBO COMPARATOR

Two tablets of the placebo are orally administered 3 times daily for 4 weeks.

Drug: Placebo oral tablet

Interventions

Rifaximin oral tablet DRUG

Patients with chronic idiopathic intestinal pseudo-obstruction (CIIPO) or patients with chronic intestinal pseudo-obstruction (CIPO), secondary to systemic scleroderma, are administered investigational product (rifaximin) for 4 weeks

Also known as: L-105

Rifaximin

Placebo oral tablet DRUG

Patients with chronic idiopathic intestinal pseudo-obstruction (CIIPO) or patients with chronic intestinal pseudo-obstruction (CIPO), secondary to systemic scleroderma, are administered placebo for 4 weeks

Placebo

Eligibility Criteria

• Age: 20 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Yokohama City University: lead
• ASKA Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Yokohama city university

Yokohama, Kanagawa, 236-0004, Japan

Location

Related Publications (2)

• Ohkubo H, Iida H, Takahashi H, Yamada E, Sakai E, Higurashi T, Sekino Y, Endo H, Sakamoto Y, Inamori M, Sato H, Fujimoto K, Nakajima A. An epidemiologic survey of chronic intestinal pseudo-obstruction and evaluation of the newly proposed diagnostic criteria. Digestion. 2012;86(1):12-9. doi: 10.1159/000337528. Epub 2012 Jun 15.

  PMID: 22710349 BACKGROUND

• Parodi A, Sessarego M, Greco A, Bazzica M, Filaci G, Setti M, Savarino E, Indiveri F, Savarino V, Ghio M. Small intestinal bacterial overgrowth in patients suffering from scleroderma: clinical effectiveness of its eradication. Am J Gastroenterol. 2008 May;103(5):1257-62. doi: 10.1111/j.1572-0241.2007.01758.x. Epub 2008 Apr 16.

  PMID: 18422815 BACKGROUND

MeSH Terms

Conditions

Intestinal Pseudo-Obstruction; Scleroderma, Systemic

Interventions

Rifaximin

Condition Hierarchy (Ancestors)

Ileus; Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2019
• First Posted: October 8, 2019
• Study Start: December 25, 2019
• Primary Completion: November 1, 2021
• Study Completion: January 1, 2022
• Last Updated: June 21, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)