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

Primary Purpose

Irritable Bowel Syndrome of Diarrhea Type (IBS-D)

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
OPS-2071
placebo
Sponsored by
Otsuka Beijing Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome of Diarrhea Type (IBS-D)

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.;

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    3 dose groups of OPS-2071

    placebo group

    Arm Description

    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 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).

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    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)
    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
    Changes in defecation frequency
    will be collected from Record of defecation frequency
    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)
    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%)
    Detection of intestinal flora
    Macrogenomic detection to detect the change of intestinal flora
    defecation urgency
    will be collected from Record of severity of IBS symptoms which included the defecation urgency(0-10) of the past 10 days
    fecal property
    will be collected from Record of bristol scale( from type1 to type7, higher type means worese)

    Full Information

    First Posted
    January 11, 2023
    Last Updated
    June 20, 2023
    Sponsor
    Otsuka Beijing Research Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05923892
    Brief Title
    Phase II Clinical Trial of OPS-2071 in the Treatment of Irritable Bowel Syndrome of Diarrhea Type
    Official Title
    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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 2023 (Anticipated)
    Primary Completion Date
    August 2024 (Anticipated)
    Study Completion Date
    August 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Otsuka Beijing Research Institute

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Irritable Bowel Syndrome of Diarrhea Type (IBS-D)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    3 dose groups of OPS-2071
    Arm Type
    Experimental
    Arm Description
    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).
    Arm Title
    placebo group
    Arm Type
    Placebo Comparator
    Arm Description
    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).
    Intervention Type
    Drug
    Intervention Name(s)
    OPS-2071
    Other Intervention Name(s)
    OPS-2071 tablets
    Intervention Description
    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).
    Intervention Type
    Drug
    Intervention Name(s)
    placebo
    Other Intervention Name(s)
    placebo tablets
    Intervention Description
    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).
    Primary Outcome Measure Information:
    Title
    Change from baseline to Week 2 in NRS (Numerical rating scale,0-10 points,higher scores mean a worse outcome )abdominal pain.
    Description
    Efficacy is defined as ≥ 30% improvement in abdominal pain symptoms compared to baseline.
    Time Frame
    2 week
    Title
    Change from baseline to Week 2 in Bristol(type 1 to type 7,higher type means worse)stool scale.
    Description
    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
    Secondary Outcome Measure Information:
    Title
    Improvement degree of abdominal pain and abnormal defecation (%)
    Description
    abdominal pain (0-100%,higher degree means better) and abnormal defecation (0-100%,0-100%,higher degree means better)
    Time Frame
    2 week
    Title
    Abdominal pain score and days of abdominal pain remission
    Description
    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
    Title
    Changes in defecation frequency
    Description
    will be collected from Record of defecation frequency
    Time Frame
    2 week
    Title
    Changes in and abdominal distension
    Description
    will be collected from Record of severity of IBS symptoms which included abdominal distension(0-10, higher degree means worse)
    Time Frame
    2 week
    Title
    Subject's subjective response
    Description
    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
    Title
    Detection of intestinal flora
    Description
    Macrogenomic detection to detect the change of intestinal flora
    Time Frame
    2 week
    Title
    defecation urgency
    Description
    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
    Title
    fecal property
    Description
    will be collected from Record of bristol scale( from type1 to type7, higher type means worese)
    Time Frame
    2 week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.;
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    peng shicheng
    Phone
    15810231577
    Email
    pengshicheng@cn.otsuka.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hou xiaohua, PhD
    Organizational Affiliation
    Wuhan Union Hospital, China
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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