Rifamycin SV-MMX® 600 mg Tablets Administered Three or Two Times Daily to Patients With IBS-D

NCT03099785 | Completed Phase 2

• 1 other identifier: CB-01-11/28
• Study Type: interventional
• Target: 279
• Locations: 4 countries
• Sites: 29

Brief Summary

The objective of this study is to evaluate the safety and efficacy Rifamycin SV-MMX® 600 mg tablets for patients with diarrhoea-predominant irritable bowel syndrome when administered two to three times daily.

Conditions

Diarrhea-predominant Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects with relief from abdominal pain and improved stool consistency.

  Proportion of weekly responders defined as subjects who weekly have relief of the composite of abdominal pain and stool consistency, on the basis of their daily assessments. Relief of abdominal pain is defined as a decrease in the weekly average of abdominal pain score of at least 30% compared with baseline and relief of stool consistency is defined as a 50% or greater reduction in the number of days per week with at least one stool that has a consistency of Type 6 or 7 compared with baseline. All participants will complete daily assessments of abdominal pain and stool consistency: * Abdominal Pain: Scored between 0 (no pain) and 10 (as bad as it could be) * Stool Consistency: Bristol Stool Scale (Scored 1-7)

  88 days

Secondary Outcomes (11)

• Proportion of subjects with relief of global IBS symptoms during weeks 3-12 [Efficacy]

  10 weeks

• Proportion of subjects with monthly relief of global IBS symptoms [Efficacy]

  88 days

• Proportion of subjects with relief of IBS-related bloating during weeks 3-12 [Efficacy]

  10 weeks

• Proportion of subjects with monthly relief of IBS-related bloating [Efficacy]

  88 days

• Proportion of subjects with weekly relief of IBS symptoms, bloating and abdominal pain [Efficacy]

  88 days

Other Outcomes (5)

• Treatment Emergent Adverse Events [Safety]

  12 weeks

• Change from Baseline in Physical Exam [Safety]

  12 weeks

• Change from Baseline in Vital Signs [Safety]

  12 weeks

Study Arms (3)

Treatment group 1: dose regimen 1

ACTIVE COMPARATOR

Rifamycin SV-MMX® 600 mg modified release tablets, three times daily (t.i.d.)

Drug: Rifamycin SV 600mg t.i.d.

Treatment group 2: dose regimen 2

ACTIVE COMPARATOR

Rifamycin SV-MMX® 600 mg modified release tablets, two times daily (b.i.d.) + matching placebo daily (q.d.)

Drug: Rifamycin SV b.i.d. + Placebo

Treatment group 3: matching placebo

PLACEBO COMPARATOR

Rifamycin SV-MMX® matching placebo tablets, t.i.d.

Drug: Placebo t.i.d.

Interventions

Rifamycin SV 600mg t.i.d. DRUG

Morning: one 600 mg tablet Afternoon: one 600 mg tablet Evening: one 600 mg tablet

Treatment group 1: dose regimen 1

Rifamycin SV b.i.d. + Placebo DRUG

Morning. one 600 mg tablet Afternoon: one matching placebo tablet Evening: one 600 mg tablet

Treatment group 2: dose regimen 2

Placebo t.i.d. DRUG

Morning. one matching placebo tablet Afternoon: one matching placebo tablet Evening: one matching placebo tablet

Treatment group 3: matching placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sex and Age: males/females, ≥18 year old
• IBS Diagnosis: confirmed IBS-D diagnosis per Rome IV criteria
• Symptoms: active symptoms of IBS at baseline (day 1) as measured by average daily scores for at least 7 days before baseline:
• abdominal pain score ≥3 using an 11-point numeric rating scale and
• bloating score: 2-4 inclusive and
• stool consistency: score 6 or 7 (measured by the 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:
• "In the past 7 days, have you had adequate relief of your IBS symptoms?" \[No\] and
• "In the past 7 days, have you had adequate relief of your IBS symptom of bloating?"\[No\]
• Colonoscopy: performed within 5 years; if patient's age \>50, colonoscopy performed within 2 years
• 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
• Literacy: sufficiently literate to comply with the study requirement of using electronic diaries and filling in electronic forms
• 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:
• Hormonal oral, implantable, transdermal, or injectable contraceptives for at least 2 months before the screening visit

You may not qualify if:

• IBS: symptoms of constipation at baseline:
• less than 3 bowel movements a week and
• stool consistency score ≤2 for ≥2 days in a week
• Screening phase: failure to record the daily symptom assessments in the diary cards for at least 7 days before baseline
• 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
• Coeliac disease: ascertained or presumptive underlying coeliac disease
• Bile: ascertained or presumptive bile acid malabsorption or bile acid induced diarrhoea
• Diabetes: underlying diabetes type I or II
• Thyroid: abnormal thyroid function not controlled by thyroid medications
• 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
• 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
• Liver function: chronic liver disease or clinically significant liver enzyme abnormality as evidenced by elevated AST, ALT or total bilirubin \>1.5 times ULN
• AIDS/HIV: ascertained or presumptive acquired immunodeficiency (AIDS) or known infection with human immunodeficiency virus (HIV)
• 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
• 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

Sponsors & Collaborators

• Cosmo Technologies Ltd: lead

Study Sites (29)

University Hospital Gasthuisberg, Department of Gastroenterology

Leuven, Herestraat 49, 3000, Belgium

Location

St Lukas Ziekenhuis,

Bruges, Lucaslaan 29, 8310, Belgium

Location

Clinique universitaires Saint-Luc Gastroenterologie Route 606 Avenue Hippocrate, 10

Brussels, 1200, Belgium

Location

Maria Middelares, Digestief Centrum, Buitenring St-Denijs 30

Ghent, 9000, Belgium

Location

University Hospital Gent, Depintelaan 185

Ghent, 9000, Belgium

Location

Emovis GmbH Wilmersdorfer Straße 79

Berlin, 10629, Germany

Location

Unterfrintroper Hausarztzentrum Lehrpraxis der Universität Essen

Essen, 45359, Germany

Location

Internistenzentrum Bahnhofstrasse 30

Gauting, 82131, Germany

Location

Clinical Research Hamburg GmbH, Rahlstedter Bahnhofstraße 33

Hamburg, 22143, Germany

Location

Gastroenterologie, Interventionelle Endoskopie, Diabetologie und Akutgeriatrie, KRH-Zentrumsgeschaftsfuhrer innere Medizin, KRK Klinikum Siloah-Oststadt-Heidehaus Stadionbrucke 4

Hanover, 30459, Germany

Location

Gemeinschaftspraxis Dr. Klein & J. Minnich

Künzing, 94550, Germany

Location

AmBeNet GmbH, Wilhelm-Leuschner-Platz I2,

Leipzig, 04107, Germany

Location

Universitatsklinikum Magdeburg A.O.R. Klinik fur Gastroenterologie, Hepatologie und Infektiologie, Leipziger Str.44

Magdeburg, 39120, Germany

Location

Ärztehaus Reinfeld Praxisgemeinschaft für Allgemeinmedizin Klosterstraße 7

Reinfeld, 23858, Germany

Location

Innomed Dr. med. Naudts Ludwig-Erhard-Platz 11

Rodgau, 63110, Germany

Location

Internistische Praxisgemeinschaft, Bereich Gastroenterologie Hauptstraße. 51

Weyhe, 28844, Germany

Location

S.O.C Gastroenterologia Oncologica

Aviano, PN, 233081, Italy

Location

Azienda Ospedaliera G. Brotzu, U.O. di Gastroenterelogia, Via Peretti

Cagliari, 09100, Italy

Location

Istituto Clinico Humanitas, Centro Malattie Infiammatorie Croniche Intestinali

Milan, 20089, Italy

Location

Fonazione IRCCS Ospedale Maggiore

Milan, 20122, Italy

Location

Fondazione IRCCS Policlinico S. Matteo, Dip Area Medica: Medicina Generale 1, Viale Camillo Golgi, 19

Pavia, 27100, Italy

Location

Polo Scienze Gastroenterologiche ed

Roma, 00168, Italy

Location

Universita Campus Bio Medico, U.O.C di Gastroenterologia ed Endoscopia Digestiva

Roma, 21, Italy

Location

IRCCS Policlinico San Donato, Medicina Generale III- Gastroenterologia

San Donato Milanese, 20097, Italy

Location

Hospital Universitari Germans Trias i Pijol (Can Ruti). Servicio de Aparto Digestivo Carretera de Canyet, s/n

Badalona, Barcelona, 08916, Spain

Location

Hospital Universitario La Paz, Servicio de Aparato Digestivo Po de la Castellana 261

Castellana, Madrid, 28046, Spain

Location

Hospital Universitario Ramon Y Cajal, Servicio de Gastroenterologia y Hepatologia Ctra. de colmenar Viejo, Km 9,100

Colmenar Viejo, Madrid, 28034, Spain

Location

Hospital Universitari vall d'Hebron, Servicio de Aparato Digestivo, Passeig Vall d'Hebron, 119-129

Barcelona, 08035, Spain

Location

Hospital Universitario Clinico San Carlos, Servicio de Aparato Digestivo, Calle del Prof Martin Lagos, s/n,

Madrid, 28040, Spain

Location

MeSH Terms

Interventions

rifamycin SV

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2017
• First Posted: April 4, 2017
• Study Start: December 18, 2017
• Primary Completion: September 11, 2020
• Study Completion: December 14, 2020
• Last Updated: January 8, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (11); BE (5); IT (8); ES (5)