CANNABIDIOL for Irritable bowel syndrome with diarrhea (IBS-D)

Inclusion criteria

• {"criterion_text":"- >=18 <=50 years old male and female\n- Ability to complete the study in compliance with the protocol; and\n- Ability to understand and provide written informed consent.\n- BMI >18 <40 kg/m2\n- Patient has a diagnosis of IBS-D\n- Has an average abdominal pain score of ≥5.5 at baseline.\n- If treated with any of the following medicaAons, dosing must be stable for 90 days prior to Screening and the subject must agree to maintain the same dose of medicaAon throughout the study: - Tricyclic anAdepressants, tetracyclic anAdepressants, selecAve serotonin reuptake inhibitors (SSRIs), and serotonin and norepinephrine reuptake inhibitors (SNRIs) for condiAons other than IBS pain, - Benzodiazepines or non-benzodiazepine hypnoAcs, administered at bedAme for condiAons other than IBS pain\n- Patient has stable eaten habits for the past 12 weeks and is not planning to change his/her lifestyle and/or diet during the study\n- Female patients if they are post-menopausal or sterilized, or if they are of childbearing potential and their pregnancy test is negative\n- All patients of childbearing potential must agree to use highly effective birth control method(s) throughout the study, and for at least 30 days after receiving the last dose of study drug; females using oral contraception must have started using the medication at least 30 days prior to screening; surgical sterilization must have occurred at least 6 weeks prior to screening.\n- Male patients must agree not to donate sperm for 30 days ager receiving study drug."}

Exclusion criteria

• {"criterion_text":"- All subjects with recent (within 6 months of Screening) or ongoing alarm features (unexplained weight loss, nocturnal symptoms, blood mixed with stool, family history of colorectal cancer or inflammatory bowel disease) without colonoscopy performed at most five years before the study screening visit (as per Appendix 1 point 1).\n- Use of the medications - prior (within 14 days before Visit 2) or anticipated concomitant prescription medication or OTC therapy for IBS including, but not limited to, abdominal pain medications, antibiotics, anticholinergics, antidiarrheals, antiflatulence agents, antispasmodics, chloride channel activators, bile acid sequestrants, cholinomimetics, 5-HT3 antagonists, 5-HT4 agonists, guanylate cyclase C agonists, opioid agonists or antagonists, osmotic laxatives, stimulant laxatives.\n- Use prior (within 30 days of Visit 1) or anticipated concomitant use of GI antibiotics.\n- Ongoing or planned use of a concomitant medication that is on the CredibleMedsTM list of drugs known to cause Torsades des Pointes (Appendix 5).\n- Participation in another clinical trial before 30 days prior Visit 1 (Screening) or planning participation in another clinical study during this study.\n- Patients with diagnosis or history of inflammatory bowel disease (IBD), colorectal cancer, diverticulitis, ischemic colitis, microscopic colitis, bile acid diarrhea, or celiac disease.\n- Clinically relevant changes in dietary, lifestyle, or exercise regimen within 30 days prior to Visit 1 (Screening) that may confound efficacy assessments in the clinical judgment of the InvesAgator (or designee).\n- Diagnosis of small intestine bacterial overgrowth (SIBO)\n- Any colonic or major abdominal surgery (e.g., bariatric surgery [including gastric banding], cholecystectomy, stomach surgery, small/large bowel surgery, or abdominal large vessel surgery). Procedures such as appendectomy, hysterectomy, cesarean section, or polypectomy are allowed if they have occurred at least 3 months prior to Visit 1 (Screening).\n- Other GI diseases such as peptic ulceration, functional dyspepsia, GI bleeding, or GI inflammatory disease (e.g., esophagitis, gastritis, or duodenitis) within 6 months prior to Visit 1 (Screening).\n- Pregnant, lactation or planning to become pregnant in the course of the study.\n- Use of any of the following medications within 30 days prior to Visit 1 (Screening): - Opioids - The following are excluded if they are prescribed for IBS pain anticonvulsants (e.g., pregabalin or gabapenAn) - Medical or recreational marijuana, tetrahydrocannabinol (THC), cannabidiol (CBD), any other minor cannabinoid (CBG, CBDA, CBN etc.) synthetic cannabinoids, and other cannabis derivatives for any indication.\n- Benzodiazepines, or non-benzodiazepine hypnotics, unless administered at bedtime for conditions other than IBS pain (stable by 90 days or not use by last 30 days)."}

Primary endpoints

• {"endpoint_text":"- Primary safety endpoints include the evaluation of AEs and SAEs (in case of SAE with deaths and relation to IMP).","definition_or_measurement_approach":"Evaluation of adverse events (AEs) and serious adverse events (SAEs), including SAEs with deaths and assessment of relationship to the investigational medicinal product (IMP)."}
• {"endpoint_text":"- Primary efficacy endpoints include change from Baseline in scores at each week of abdominal bloating, discomfort, pain, cramping and nausea as well as stool consistency response: the average BSFS score of all reported bowel movements on the specific day (daily average).","definition_or_measurement_approach":"Change from Baseline measured weekly for abdominal bloating, discomfort, pain, cramping and nausea; stool consistency response measured as the average Bristol Stool Form Scale (BSFS) score of all reported bowel movements on the specific day (daily average)."}

Secondary endpoints

• {"endpoint_text":"- Change from Baseline in abdominal pain, diarrhea, stool consistency, abdominal discomfort, bloating and cramping, nausea, percent change in abdominal pain – all at their worst; 6/12 week responder from Baseline in abdominal pain (≥30% decrease and ≥2-point improvement), abdominal discomfort (≥2-point improvement), bloating (≥2-point improvement and increase of ≥1 CSBM/week); treatment satisfaction; adequate relief; change in diarrhea and QOL assessment at weeks 4, 8 and 12.","definition_or_measurement_approach":"Change from Baseline in listed symptoms with responder definitions specified (e.g., abdominal pain responder = ≥30% decrease and ≥2-point improvement); assessments at weeks 4, 8 and 12; includes treatment satisfaction, adequate relief, diarrhea change and quality-of-life (QOL) measures."}

Poland

Earliest CTIS Part Ii Submission Date

23-08-2024

Latest Decision Or Authorization Date

24-11-2024

Processing Time Days

93

Number Of Sites

1

Number Of Participants

35

Primary sponsor

Full Name

Cannabibs Sp. z o.o.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Poland

Third parties

• {"country":"Poland","full_name":"CTC Team Sp. z o.o.","duties_or_roles":"codes: 1,12","organisation_type":"Pharmaceutical company"}
• {"country":"Netherlands","full_name":"Echo Pharmaceuticals B.V.","duties_or_roles":"codes: 14","organisation_type":"Pharmaceutical company"}