Clinical trial NCT05923892: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Irritable Bowel Syndrome of Diarrhea Type (IBS-D)
Lead sponsor: Otsuka Beijing Research Institute
Sponsor class: INDUSTRY
First posted: 2023-06-28
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.;

Primary outcomes:
measure: Change from baseline to Week 2 in NRS (Numerical rating scale,0-10 points,higher scores mean a worse outcome )abdominal pain.
timeFrame: 2 week
measure: Change from baseline to Week 2 in Bristol（type 1 to type 7，higher type means worse）stool scale.
timeFrame: 2 week
Secondary outcomes:
measure: Improvement degree of abdominal pain and abnormal defecation (%)
timeFrame: 2 week
measure: Abdominal pain score and days of abdominal pain remission
timeFrame: 2 week
measure: Changes in defecation frequency
timeFrame: 2 week
measure: Changes in and abdominal distension
timeFrame: 2 week
measure: Subject's subjective response
timeFrame: 2 week
measure: Detection of intestinal flora
timeFrame: 2 week
measure: defecation urgency
timeFrame: 2 week
measure: fecal property
timeFrame: 2 week
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Wuhan Union Hospital, China
name: Hou xiaohua, PhD
role: PRINCIPAL_INVESTIGATOR
References: