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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04118699
Other study ID # YCU19001
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date December 25, 2019
Est. completion date January 2022

Study information

Verified date June 2021
Source Yokohama City University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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 information / eligibility

Status Active, not recruiting
Enrollment 12
Est. completion date January 2022
Est. primary completion date November 2021
Accepts healthy volunteers No
Gender All
Age group 20 Years to 74 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Rifaximin oral tablet
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
Placebo oral tablet
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

Locations

Country Name City State
Japan Yokohama city university Yokohama Kanagawa

Sponsors (2)

Lead Sponsor Collaborator
Yokohama City University ASKA Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

References & 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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Small intestinal bacterial overgrowth (SIBO) in a glucose-hydrogen breath test Elimination rate of SIBO in a glucose-hydrogen breath test Before, 4 weeks after administration;and 8 weeks after the end of administration
Other Changes of Serum endotoxin activity Serum endotoxin activity, ranging from 0.00-1.00, is assessed using EAA® (endotoxin activity assay, Toray Medical Co., Ltd.), FDA approved rapid whole blood assay for detection of human endotoxemia. 0.00-0.39 means low level, 0.40-0.59 means middle level, and =0.60 means high level. Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration
Other Fecal test (intestinal flora) Changes of intestinal flora detected by 16SrDNA amplicon analysis using next generation sequencing. Before and 4 weeks after administration
Other Adverse events Incidence of adverse events From the start of administration to 8 weeks after the end of administration
Other Changes from baseline of hematological parameters Hematological parameters (red blood cell count, hematocrit, white blood cell count, platelet count) are calculated for safety assessment Before, 2 and 4 weeks after administration; and 4 and 8 weeks after the end of administration
Other Changes from the baseline of total protein Total protein is calculated for safety assessment Before, 2 and 4 weeks after administration; and 4 and 8 weeks after the end of administration
Other Changes from the baseline of liver function Liver function parameters (aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transpeptidase, alkaline phosphatase, total bilirubin) are calculated for safety assessment. Before, 2 and 4 weeks after administration; and 4 and 8 weeks after the end of administration
Other Changes from the baseline of renal function Creatinine and blood urea nitrogen are calculated for safety assessment. Before, 2 and 4 weeks after administration; and 4 and 8 weeks after the end of administration
Other Changes from the baseline of electrolytes Electrolytes (sodium, potassium, chlorine, calcium) are calculated for safety assessment. Before, 2 and 4 weeks after administration; and 4 and 8 weeks after the end of administration
Other Changes from the baseline of blood lipid level Blood lipid level (total cholesterol, triglyceride, and high-density lipoprotein cholesterol) is calculated for safety assessment. Before, 2 and 4 weeks after administration; and 4 and 8 weeks after the end of administration
Other Changes from the baseline of C reactive protein C reactive protein is calculated for safety assessment. Before, 2 and 4 weeks after administration; and 4 and 8 weeks after the end of administration
Other Changes from the baseline of serum glucose level Serum glucose level is calculated for safety assessment. Before, 2 and 4 weeks after administration; and 4 and 8 weeks after the end of administration
Primary 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)
Primary 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 Changes of the improvement ratio (%) in abdominal bloating score 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. Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration
Secondary Changes of abdominal bloating score 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. Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration
Secondary Changes of the improvement ratio (%) in gastrointestinal symptoms score 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. Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration
Secondary Changes of the "good" ratio (%) in gastrointestinal symptoms score 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''. Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration
Secondary Changes of each score in Global Symptomatic Score other than abdominal bloating score 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). Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration
Secondary Changes of total scores in Global Symptomatic Score 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). Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration
Secondary Changes of the improvement ratio (%) in General health condition (symptoms) score 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. Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration
Secondary Changes of the "good" ratio (%) in General health condition (symptoms) score 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''. Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration
Secondary Patient satisfaction score % of the "satisfaction" ratio in patient satisfaction score At the end of the administration (4 weeks)
Secondary Changes of Short Form (SF)-8 health survey score 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. Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration
Secondary Small intestinal volume measured by abdominal CT scan Changes of 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
Secondary Changes from baseline of serum albumin level Serum albumin level is calculated for nutritional assessment Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration
Secondary Changes from baseline of prealbumin (transthyretin) Prealbumin (transthyretin) is calculated for nutritional assessment Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration
Secondary Changes from baseline of cholinesterase Cholinesterase is calculated for nutritional assessment Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration
Secondary Changes from baseline of folic acid Folic acid is calculated for nutritional assessment Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration
Secondary Changes from baseline of vitamin B12 (cobalamin) Vitamin B12 (cobalamin) is calculated for nutritional assessment Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration
Secondary Changes from baseline of serum iron Serum iron is calculated for nutritional assessment Before, 2 and 4 weeks after administration;and 4 and 8 weeks after the end of administration
See also
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