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

NCT05923892 | Completed Phase 2

• 1 other identifier: 341-403-00010
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Irritable Bowel Syndrome of Diarrhea Type (IBS-D)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Improvement degree of abdominal pain and abnormal defecation (%)

  2 week

• Abdominal pain score and days of abdominal pain remission

  2 week

• Changes in defecation frequency

  2 week

• Changes in and abdominal distension

  2 week

• Subject's subjective response

  2 week

Study Arms (2)

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).

Drug: OPS-2071

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).

Drug: placebo

Interventions

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).

Also known as: OPS-2071 tablets

3 dose groups of OPS-2071

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).

Also known as: placebo tablets

placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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.;

Sponsors & Collaborators

• Otsuka Beijing Research Institute: lead

Study Sites (1)

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

Location

Study Officials

• Hou xiaohua, PhD

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: June 28, 2023
• Study Start: August 2, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: April 3, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)