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

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Irritable Bowel Syndrome of Diarrhea Type (IBS-D)
• Intervention / Treatment: Drug: OPS-2071; Drug: placebo

Detailed Description

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
• Enrollment (Estimated): 80
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: peng shicheng; Phone Number: 15810231577; Email: pengshicheng@cn.otsuka.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Recruiting
      • Union Hospital Tongji Medical College Huazhong University Of Science And Technology
      • Contact: Hou hou, doctor; Phone Number: 13035143646; Email: houxh@hust.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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;
2. Subjects aged 18 to 65 years at the time of ICF signing;
3. Subjects who meet Rome IV diagnostic criteria for IBS-D;
4. The following criteria should be met during the screening period:

Exclusion Criteria:

1. 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;
2. 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;
3. 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);
4. 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.;
5. Subjects with previously confirmed diagnosis of non-intestinal digestive diseases, such as tuberculous peritonitis, gallstones, cirrhosis, chronic pancreatitis, etc.;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3 dose groups of OPS-2071; 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; 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).; Other Names: OPS-2071 tablets
Placebo Comparator: placebo group; 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; 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).; Other Names: placebo tablets

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Otsuka Beijing Research Institute
• Investigators: Principal Investigator: Hou xiaohua, PhD, Wuhan Union Hospital, China

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2023
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: January 11, 2023
• First Submitted That Met QC Criteria: June 20, 2023
• First Posted (Actual): June 28, 2023

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome; Diarrhea
• Other Study ID Numbers: 341-403-00010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No