This is a A Multicenter, Randomized, Double-blind, Placebo-controlled, Clinical Trial to Evaluate the Efficacy and Safety of Different Doses of OPS-2071 in the Treatment of Irritable Bowel Syndrome of Diarrhea type (IBS-D).The trial is mainly divided into three periods: screening period, treatment period and follow-up period.
Screening period: After signing the Informed Consent Form, subjects entered a 14-day screening period to evaluate inclusion/exclusion criteria and collect demographic information, medical history, etc. Subject's previous medication should be eluted and concomitant medications should be prohibited. Treatment period: After the screening period, subjects who meet the inclusion criteria and do not meet the exclusion criteria will be randomly assigned (1:1:1:1) to four treatment groups to receive a 2-week treatment period. Weekly follow-up and relevant examinations will be performed. Follow-up period: The safety follow-up visit will be conducted by telephone on Day14 (+2) after the last dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
87
There are 3 dose groups of OPS-2071,OPS-2071 tablets, 50 mg、100mg、200mg. Take 4 tablets/bid, after meals in the morning and evening, with an interval of at least 8 hours for 2 weeks(The dosing interval will be 12 hours from Day 5 to Day 7).
Take 4 tablets/bid, after meals in the morning and evening, with an interval of at least 8 hours for 2 weeks(The dosing interval will be 12 hours from Day 5 to Day 7).
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Change from baseline to Week 2 in NRS (Numerical rating scale,0-10 points,higher scores mean a worse outcome )abdominal pain.
Efficacy is defined as ≥ 30% improvement in abdominal pain symptoms compared to baseline.
Time frame: 2 week
Change from baseline to Week 2 in Bristol(type 1 to type 7,higher type means worse)stool scale.
Efficacy is defined as ≥ 50% reduction in the number of days with at least one stool that has a consistency of Bristol stool scale of 6 or 7 for at least 50% of the treatment period.
Time frame: 2 week
Improvement degree of abdominal pain and abnormal defecation (%)
abdominal pain (0-100%,higher degree means better) and abnormal defecation (0-100%,0-100%,higher degree means better)
Time frame: 2 week
Abdominal pain score and days of abdominal pain remission
will be collected from Record of severity of IBS symptoms which included the severity of abdominal pain(from 0 to 100%,higher degree means worse) and the day of abdominal pain in the past 10 days
Time frame: 2 week
Changes in defecation frequency
will be collected from Record of defecation frequency
Time frame: 2 week
Changes in and abdominal distension
will be collected from Record of severity of IBS symptoms which included abdominal distension(0-10, higher degree means worse)
Time frame: 2 week
Subject's subjective response
will be collected from Record of severity of IBS symptoms which included the subject's satisfacation degree of his defecation habbit(0-100%) and the influence of the IBS symptoms in his life(0-100%)
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Time frame: 2 week
Detection of intestinal flora
Macrogenomic detection to detect the change of intestinal flora
Time frame: 2 week
defecation urgency
will be collected from Record of severity of IBS symptoms which included the defecation urgency(0-10) of the past 10 days
Time frame: 2 week
fecal property
will be collected from Record of bristol scale( from type1 to type7, higher type means worese)
Time frame: 2 week