Efficacy and Safety of Rifaximin for Patients With Chronic Intestinal Pseudo-obstruction: a Phase… (NCT04118699) | Clinical Trial Compass
UnknownPhase 2
Efficacy and Safety of Rifaximin for Patients With Chronic Intestinal Pseudo-obstruction: a Phase 2 Trial
Japan12 participantsStarted 2019-12-25
Plain-language 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
Who can participate
Age range20 Years – 74 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 d…
What they're measuring
1
Improvement ratio (%) in abdominal bloating score in Global Symptomatic Score (GSS)
Timeframe: at the end of administration (4 weeks)
2
Improvement ratio (%) in Gastrointestinal (GI) symptoms score