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| Name | Class |
|---|---|
| ASKA Pharmaceutical Co., Ltd. | INDUSTRY |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rifaximin | Experimental | Two tablets of the investigational product per dosing (400 mg of rifaximin) are orally administered 3 times daily for 4 weeks. |
|
| Placebo | Placebo Comparator | Two tablets of the placebo are orally administered 3 times daily for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Changes of Serum endotoxin activity |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yokohama city university | Yokohama | Kanagawa | 236-0004 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22710349 | Background | 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. | |
| 18422815 |
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| ID | Term |
|---|---|
| D007418 | Intestinal Pseudo-Obstruction |
| D012595 | Scleroderma, Systemic |
| ID | Term |
|---|---|
| D045823 | Ileus |
| D007415 | Intestinal Obstruction |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D000078262 | Rifaximin |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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|
| 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 |
|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Patient satisfaction score | % of the "satisfaction" ratio in patient satisfaction score | At the end of the administration (4 weeks) |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
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 |
| Fecal test (intestinal flora) | Changes of intestinal flora detected by 16SrDNA amplicon analysis using next generation sequencing. | Before and 4 weeks after administration |
| Adverse events | Incidence of adverse events | From the start of administration to 8 weeks after the end of administration |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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. |
| D004066 |
| Digestive System Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |