Irritable Bowel Syndrome of Diarrhea Type (IBS-D)Phase 2NCT05923892
Phase II Clinical Trial of OPS-2071 in the Treatment of Irritable Bowel Syndrome of Diarrhea Type
A Phase 2 study testing OPS-2071 in people with Irritable Bowel Syndrome of Diarrhea Type (IBS-D), run by Otsuka Beijing Research Institute at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome of Diarrhea Type (IBS-D)
- What is being tested?
- OPS-2071
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 1 siteChina
- Study dates
- 2 Aug 2023to 1 Aug 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Who cannot join
- 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.;
Trial locations and contacts
1 site in 1 country.
China1 site
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430000
About this study
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)
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.
Read the 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.
- Being tested
- OPS-2071, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPS-2071Drug
Also called OPS-2071 tablets
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).
placeboDrug
Also called 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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 week
Secondary outcomes (8)
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)
Measured: 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
Measured: 2 week
Changes in defecation frequency
will be collected from Record of defecation frequency
Measured: 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)
Measured: 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%)
Measured: 2 week
Detection of intestinal flora
Macrogenomic detection to detect the change of intestinal flora
Measured: 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
Measured: 2 week
fecal property
will be collected from Record of bristol scale( from type1 to type7, higher type means worese)
Measured: 2 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start2 Aug 2023
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel Syndrome of Diarrhea Type (IBS-D)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Beijing Research Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hou xiaohua, PhD, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05923892
- Sponsor's protocol ID
- 341-403-00010
- Status last verified
- Apr 2024
- First submitted
- 11 Jan 2023
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05923892
- Acronym / sponsor ID
- 341-403-00010
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Otsuka Beijing Research InstituteIndustry (pharma, biotech, devices)
- Study start
- 2 Aug 2023 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 28 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3 dose groups of OPS-2071 | Experimental | Drug: OPS-2071OPS-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 | Drug: placeboPlacebo 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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:
Key exclusion criteria (5 listed)
- 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.;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OPS-2071Also: OPS-2071 tabletsThere 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). | Drug | 3 dose groups of OPS-2071 |
| placeboAlso: placebo tabletsTake 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 group |
Primary outcome
Change from baseline to Week 2 in NRS (Numerical rating scale,0-10 points,higher scores mean a worse outcome )abdominal pain.
Time frame: 2 week
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.
Time frame: 2 week
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.
8 secondary outcomes
Improvement degree of abdominal pain and abnormal defecation (%)
Time frame: 2 week
Abdominal pain score and days of abdominal pain remission
Time frame: 2 week
Changes in defecation frequency
Time frame: 2 week
Changes in and abdominal distension
Time frame: 2 week
Subject's subjective response
Time frame: 2 week
Detection of intestinal flora
Time frame: 2 week
defecation urgency
Time frame: 2 week
fecal property
Time frame: 2 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Irritable Bowel Syndrome of Diarrhea Type (IBS-D)
Recruiting
Evaluation of the Efficacy and Safety of Gelsectan in the Treatment of Diarrhea-predominant Irritable Bowel Syndrome
Diarrhea-predominant Irritable Bowel Syndrome, Irritable Bowel Syndrome of Diarrhea Type (IBS-D)
Recruiting
Gelsectan® in the Treatment of Patients With Diarrhoea-predominant Irritable Bowel Syndrome
Irritable Bowel Syndrome (IBS), Irritable Bowel Syndrome of Diarrhea Type (IBS-D)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hou xiaohua, PhD principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OPS-2071 in people with Irritable Bowel Syndrome of Diarrhea Type (IBS-D), run by Otsuka Beijing Research Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to Week 2 in NRS (Numerical rating scale,0-10 points,higher scores mean a worse outcome )abdominal pain. (time frame: 2 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.