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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3 dose groups of OPS-2071 | Experimental | 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). |
|
| placebo group | Placebo Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPS-2071 | Drug | 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). |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hou xiaohua, PhD | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Union Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan | Hubei | 430000 | China |
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| placebo | Drug | 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). |
|
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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 |