Irritable Bowel Syndrome with Diarrhea (IBS-D)
Conditions
Interventions
placebo group:placebo
Medium-dose drug group:OPS-2071 100 mg/bid
High-dose drug group:OPS-2071 200 mg/bid
Low-dose drug group:OPS-2071 50 mg/bid
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Be able to fully understand and willing to comply with the trial process, voluntarily participate in this trial and sign the informed consent form; 2. Signed informed consent, age >= 18 and =3.0; (2)Stool consistency classified as Bristol 6 or 7, and for at least =2 days per week; (3)Completion of diary card records for at least 10 days; (4)Taking emergency medication (pinaverium) continuously or intermittently for <=2 days. 5. Subjects who are able to maintain a stable lifestyle and dietary habits during the trial period, without making any new major changes that may affect IBS-D symptoms (e.g., starting a new diet or changing usual lifestyle habits).
Exclusion criteria
Exclusion criteria: 1. Within the previous 14 days before screening, subjects accompanied by gastrointestinal alarm symptoms such as rectal bleeding, positive fecal occult blood test, anemia, abdominal mass, ascites, fever, unexplained weight loss, nocturnal diarrhea; 2. Patients with a definite diagnosis of organic gastrointestinal diseases, such as inflammatory bowel disease, intestinal tuberculosis, intestinal polyps (excluding polyps = 15 days), intestinal diverticula, intestinal tumors, etc., or who still have peptic ulcers or infectious diarrhea; 3. Individuals with a prior definitive diagnosis of conditions affecting digestive system function, such as uncontrolled hyperthyroidism or hypothyroidism, chronic renal failure, autoimmune diseases, diabetes mellitus, neurological disorders (e.g., anorexia nervosa), or severe psychiatric illnesses (e.g., major depression or severe anxiety), among others; 4. Diseases previously diagnosed that have similar symptoms to IBS, such as eosinophilic gastroenteritis, microscopic colitis (including collagenous colitis and lymphocytic colitis), lactose intolerance, malabsorption syndrome, etc.; 5. Those with a previous clear diagnosis of non-intestinal digestive system diseases, such as tuberculous peritonitis, gallstones, cirrhosis, chronic pancreatitis, etc.; 6. A history of digestive system surgery (excluding appendectomy and polypectomy), such as cholecystectomy; 7. Previously suffered from severe heart and blood vessel diseases, hematopoietic system diseases or tumors; 8. Subjects with known or suspected (family history, unexplained syncope) long QT syndrome; 9. Subjects who are allergic to quinolones and test drug ingredients; 10. Suspected or confirmed history of alcohol or drug abuse; 11The following laboratory test values or electrocardiogram examination results were abnormal: (1) Alanine aminotransferase (ALT) > 1.5 times the upper limit of normal (ULN); (2) Aspartate aminotransferase (AST) > 1.5 times ULN; (3)otal bilirubin > 1.5 times ULN; (4)Serum creatinine (Cr) > 1.5 times ULN; (5)QTc interval: male > 450 ms, female > 470 ms. 12. From the time of signing the informed consent form until the end of the observation period, medications that affect gastrointestinal motility and function, such as prokinetics, anticholinergics, calcium channel blockers, 5-HT3 receptor antagonists, anti-diarrheals, antacids, antidepressants, anxiolytics, intestinal microbiota modulators, and antibiotics, should not be discontinued or planned for use. 13. Subjects who need to take UGT1A1 inhibitors, UGT1A9 inhibitors or BCRP inhibitors from the time of signing the informed consent form until the end of the observation period; 14. Subjects who have participated in any clinical trial and received treatment within the past three months. 15. Pregnant or breastfeeding women; 16. From the time of signing the informed consent form until 4 weeks after the last dose of trial drug, the subject or the subject's partner plans to become pregnant during the trial period or is unwilling to take reliable contraceptive measures for contraception. 17. The investigator feels that the subject has other conditions that preclude his/her participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Abdominal pain;Type of stool; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in bowel movement frequency;Improvement in abdominal pain;Subjective relief in the subjects;Changes in the sense of urgency to defecate;Changes in the consistency of stool;Improvement in abnormal bowel movements;Gut microbiota;Changes in abdominal discomfort;Safety; | — |
Countries
China
Contacts
Public ContactHou Xiaohua
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed