EUCTR2016-004977-42-ESActive, not recruitingPhase 1
A Phase II, multicentre, randomised, double-blind, placebocontrolled, proof of concept study of efficacy and safety ofRifamycin SV-MMX® 600 mg tablets administered three or twotimes daily to patients with diarrhoea-predominant irritablebowel syndrome (IBS-D)
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Cosmo Technologies Ltd.
- Enrollment
- 342
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Informed consent: signed written informed consent before inclusion in the study
- •2. Sex and Age: males/females, =18 year old
- •3. IBS diagnosis: confirmed IBS-D diagnosis per Rome IV criteria
- •4. Symptoms: active symptoms of IBS at baseline (day 1) as measured by average daily scores for at least 7 days before baseline:
- •a. abdominal pain score =3 using an 11-point numeric rating scale and
- •b. bloating score: 2-4 inclusive and
- •c. stool consistency: score 6 or 7 (Bristol stool form scale) for at least 2 days from day -7 to day -1
- •and by a negative response to the global IBS symptom assessment question and to the IBS-related bloating assessment question both given weekly during the screening phase up to day 1 before randomisation:
- •d. In the past 7 days, have you had adequate relief of your IBS symptoms? [No] and
- •e. In the past 7 days, have you had adequate relief of your IBS symptom of bloating?[No]
- •5. Colonoscopy: performed within 5 years; if patient’s age >50, colonoscopy performed within 2 years
- •6. Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the study
- •7. Literacy: sufficiently literate to comply with the study requirement of using electronic diaries and filling in electronic forms
- •8. Contraception and fertility: females of childbearing potential and fertile males must be using at least one reliable method of contraception.
- •Reliable methods of contraception for women include:
- •a. Hormonal oral, implantable, transdermal, or injectable contraceptives for at least 2 months before the screening visit
- •b. A non-hormonal intrauterine device [IUD] or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide for at least 2 months
- •before the screening visit
- •Reliable methods of contraception for men and male partners of female patients include:
- •c. Male condoms with spermicide
- •Reliable methods of contraception for both women and men include:
- •d. A sterile sexual partner or sexual abstinence
- •Women of non-childbearing potential or in post-menopausal status for at least 1 year and sterile or surgically sterilised men will be admitted.
- •For women of childbearing potential, serum pregnancy test result must be negative at screening
- •Baseline data collected from Day -14 to Day -1 will be considered for the evaluation of inclusion criterion 4 at Visit 2 – Day 1.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 272
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
Exclusion Criteria
- •1. IBS: symptoms of constipation at baseline:
- •a. less than 3 bowel movements a week and
- •b. stool consistency score =2 for =2 days in a week
- •2. Screening phase: failure to record the daily symptom assessments in the diary cards for at least 7 days before baseline
- •3. Gastroenteric: underlying gastrointestinal diseases including ulcerative colitis, Crohn’s disease, pancreatitis,any active infectious, haemorrhagic or inflammatory disorder not related to IBS-D, gastrointestinal motility disorders such as ileus, gastroparesis or pseudoobstruction, gastroduodenal ulcer, gastrointestinal malignancy
- •or potentially fatal diseases if not full in remission (5 years from diagnosis and without maintenance treatment), amyloidosis and cholelithiasis if cholecystectomy not performed
- •4. Intolerance: ascertained underlying lactose intolerance with response to diet or any other malabsorption syndrome with the exclusion of asymptomatic lactose malabsorption
- •5. Coeliac disease: ascertained or presumptive underlying coeliac disease
- •6. Bile: ascertained or presumptive bile acid malabsorption or bile acid induced diarrhoea
- •7. Diabetes: underlying diabetes type I or II
- •8. Thyroid: abnormal thyroid function not controlled by thyroid medications
- •9. Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients;
- •history of anaphylaxis to drugs or allergic reactions in general, which the investigator considers may affect
- •the outcome of the study
- •10. Renal function: ascertained or presumptive clinically significant renal insufficiency or creatinine above twice the upper limit of normal (ULN) of the performing laboratory reference range
- •11. Liver function: chronic liver disease or clinically significant liver enzyme abnormality as evidenced by
- •elevated AST, ALT or total bilirubin >1.5 times ULN
- •12. AIDS/HIV: ascertained or presumptive acquired immunodeficiency (AIDS) or known infection with human
- •immunodeficiency virus (HIV)
- •13. Diseases: significant history of medical or surgical conditions excluding hysterectomy, caesarean section,
- •appendectomy, cholecystectomy, benign polypectomy and inguinal hernia and including renal, hepatic, cardiovascular, haematological, endocrine, immune, psychiatric or neurological diseases that in the
- •investigator’s opinion may interfere with the aim of the study; malignant diseases not in remission for at least 5 years
- •14. Medications: alosetron, eluxadoline, ondansetron, tegaserod, lubiprostone, warfarin, antipsychotic,antispasmodic, prokinetic, antidiarrhoeal, laxative, probiotic, narcotic or antibiotic agents within 14 days before the screening visit; antidepressant agents of the selective serotonin-reuptake inhibitor and tricyclic classes unless taken at a stable dose for at least 6 weeks before the screening visit
- •15. Investigational drugs: participation in the evaluation of any investigational product within 30 days before this study
- •16. Drug and alcohol: known history of drug or alcohol [>1 drink/day for females and >2 drinks/day for males, defined according to the USDA Dietary Guidelines 2015] abuse
- •17. Pregnancy (females only): pregnant or lactating women or wishing to become pregnant in the 3 months following this visit
Investigators
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