A Phase 2 interventional study of OPS-2071 and placebo in Irritable Bowel Syndrome of Diarrhea Type (IBS-D), sponsored by Otsuka Beijing Research Institute. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-04-03.
Sponsored by Otsuka Beijing Research Institute · Phase 2, Interventional, and Treatment
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.
1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.
This study's enrollment of 87 is above the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →Otsuka Beijing Research Institute is the lead sponsor of 36 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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
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
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).
Also known as: OPS-2071 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).
Also known as: placebo tablets
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%)
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
Plan to share: No
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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Otsuka Beijing Research Institute