Phase II Clinical Trial of OPS-2071 in the Treatment of Irritable Bowel Syndrome of Diarrhea Type

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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)

Conditions
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Irritable Bowel Syndrome of Diarrhea Type (IBS-D)

Intervention / Treatment
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* Drug: OPS-2071
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who are able to fully understand and willing to comply with the trial procedures, and voluntarily participate in the trial and sign the Informed Consent Form; Subjects aged 18 to 65 years at the time of ICF signing; Subjects who meet Rome IV diagnostic criteria for IBS-D; The following criteria should be met during the screening period: Exclusion Criteria: Subjects who have gastrointestinal alarm symptoms within 14 days before screening, such as hematochezia, positive fecal occult blood test, anemia, abdominal mass, ascites, fever, unexplained body mass loss, and nocturnal diarrhea; Subjects with previously confirmed diagnosis of digestive organic diseases, such as inflammatory bowel disease, intestinal tuberculosis, intestinal polyps (except for polyps ≤ 0. 3 cm or polypectomy time ≥ 15 days), intestinal diverticulum, intestinal tumor, etc., or patients still complicated with peptic ulcer and infectious diarrhea; Subjects with previously confirmed diagnosis of diseases affecting digestive system function, such as uncontrolled hyperthyroidism or hypothyroidism, chronic renal failure, autoimmune diseases, diabetes, and neurological (such as anorexia nervosa) or serious psychiatric system diseases (such as major depression or severe anxiety); Subjects with previously confirmed diagnosis of diseases with symptoms similar to IBS, such as eosinophilic enteritis, microscopic colitis (including collagenous colitis and lymphocytic colitis), lactose intolerance, malabsorption syndrome, etc.; Subjects with previously confirmed diagnosis of non-intestinal digestive diseases, such as tuberculous peritonitis, gallstones, cirrhosis, chronic pancreatitis, etc.;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3 dose groups of OPS-2071<br>OPS-2071 tablets, 50 mg OPS-2071 tablets, 100 mg OPS-2071 tablets, 200 mg 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). | Drug: OPS-2071<br>* 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).<br>* Other names: OPS-2071 tablets;|
| Placebo Comparator: placebo group<br>Placebo tablets 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). | Drug: placebo<br>* 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).<br>* Other names: placebo tablets;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 2 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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 | 2 week | 
| Changes in defecation frequency | will be collected from Record of defecation frequency | 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) | 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%) | 2 week | 
| Detection of intestinal flora | Macrogenomic detection to detect the change of intestinal flora | 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 | 2 week | 
| fecal property | will be collected from Record of bristol scale( from type1 to type7, higher type means worese) | 2 week |