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

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ClinicalTrials.gov Identifier: NCT03099785
Recruitment Status : Recruiting
First Posted : April 4, 2017
Last Update Posted : November 20, 2018
Sponsor:
Information provided by (Responsible Party):
Cosmo Technologies Ltd

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.

Condition or disease Intervention/treatment Phase
Diarrhea-predominant Irritable Bowel Syndrome Drug: Rifamycin SV 600mg t.i.d. Drug: Rifamycin SV b.i.d. + Placebo Drug: Placebo t.i.d. Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 342 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II, Multicentre, Randomised, Double-blind, Placebo Controlled, Proof of Concept Study of Efficacy and Safety of Rifamycin SV-MMX® 600 mg Tablets Administered Three or Two Times Daily to Patients With Diarrhoea-predominant Irritable Bowel Syndrome (IBS-D)
Actual Study Start Date : December 18, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arm Intervention/treatment
Active Comparator: Treatment group 1: dose regimen 1
Rifamycin SV-MMX® 600 mg modified release tablets, three times daily (t.i.d.)
Drug: Rifamycin SV 600mg t.i.d.
Morning: one 600 mg tablet Afternoon: one 600 mg tablet Evening: one 600 mg tablet

Active Comparator: Treatment group 2: dose regimen 2
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
Morning. one 600 mg tablet Afternoon: one matching placebo tablet Evening: one 600 mg tablet

Placebo Comparator: Treatment group 3: matching placebo
Rifamycin SV-MMX® matching placebo tablets, t.i.d.
Drug: Placebo t.i.d.
Morning. one matching placebo tablet Afternoon: one matching placebo tablet Evening: one matching placebo tablet




Primary Outcome Measures :
  1. Proportion of subjects with relief from abdominal pain and improved stool consistency. [ Time Frame: 88 days ]

    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)


Secondary Outcome Measures :
  1. Proportion of subjects with relief of global IBS symptoms during weeks 3-12 [Efficacy] [ Time Frame: 10 weeks ]
    Proportion of subjects with adequate relief of global IBS symptoms for at least 2 (consecutive or not) of the 10 weeks during the follow-up period (i.e., weeks 3 through 12). Adequate relief of global IBS symptoms is defined as a response of "yes" to the following question, which will be asked weekly (every 7 days): "In regard to all your symptoms of IBS, as compared to the way you felt before you started study medication, have you, in the past 7 days, had adequate relief of your IBS symptoms? [Yes/No]"

  2. Proportion of subjects with monthly relief of global IBS symptoms [Efficacy] [ Time Frame: 88 days ]
    Proportion of subjects with adequate relief of global IBS symptoms during at least 2 weeks (consecutive or not) per month ("monthly response") during month 1, during month 1 through 2 and during month 1 through 3 will be assessed to identify the onset and duration of the therapeutic effect.

  3. Proportion of subjects with relief of IBS-related bloating during weeks 3-12 [Efficacy] [ Time Frame: 10 weeks ]
    Proportion of subjects with adequate relief of IBS-related bloating for at least 2 (consecutive or not) of the 10 weeks during the follow-up period (i.e., weeks 3 through 12). Adequate relief of bloating is defined as a response of "yes" to the following question, which will be asked weekly (every 7 days): "In regard to your symptom of bloating, as compared to the way you felt before you started study medication, have you, in the past 7 days, had adequate relief of your IBS symptom of bloating? [Yes/No]."

  4. Proportion of subjects with monthly relief of IBS-related bloating [Efficacy] [ Time Frame: 88 days ]
    Proportion of subjects with adequate relief of bloating during at least 2 weeks (consecutive or not) per month ("monthly response") during month 1, during month 1 through 2 and during month 1 through 3 will be assessed to identify the onset and duration of the therapeutic effect.

  5. Proportion of subjects with weekly relief of IBS symptoms, bloating and abdominal pain [Efficacy] [ Time Frame: 88 days ]

    Proportion of subjects with relief (weekly responders) determined from the subjects' daily assessments of IBS symptoms, bloating, and abdominal pain; relief of IBS symptoms and bloating is defined as a score of either 0 (not at all) or 1 (hardly) for at least 50% of the days in a given week or a score of 0 (not at all), 1 (hardly), or 2 (somewhat) for 100% of the days in a given week for at least 2 (consecutive or not) of the 4 weeks during a given month. Relief of abdominal pain is defined as a decrease by ≥30% from baseline in weekly mean rating of IBS-related abdominal pain.

    All participants will complete daily assessments of IBS symptoms, bloating and abdominal pain:

    • IBS Symptoms: Scored between 0 (Not bothersome at all) and 6 (a very great deal bothersome)
    • Bloating: Scored between 0 (not at all bothersome) and 6 (a very great deal bothersome)
    • Abdominal Pain: Scored between 0 (no pain) and 10 (as bad as it could be)

  6. Number of weeks of IBS-symptom relief during follow-up [Efficacy] [ Time Frame: 10 weeks ]
    Number of weeks (consecutive or not) subjects achieve adequate relief of IBS symptoms during the follow up period.

  7. Number of weeks of bloating relief during follow-up [Efficacy] [ Time Frame: 10 weeks ]
    Number of weeks (consecutive or not) subjects achieve adequate relief of bloating during the follow up period.

  8. Change in IBS-symptoms, bloating and abdominal pain from baseline to 12 weeks - captured by a daily diary [Efficacy] [ Time Frame: 12 weeks ]

    Change from baseline to week 12 in daily IBS symptoms, bloating and abdominal pain. This information will be captured in a daily diary by the participants.

    All participants will complete daily assessments of IBS symptoms, bloating and abdominal pain:

    • IBS Symptoms: Scored between 0 (Not bothersome at all) and 6 (a very great deal bothersome)
    • Bloating: Scored between 0 (not at all bothersome) and 6 (a very great deal bothersome)

  9. Proportion of monthly responders for IBS-symptoms, bloating and abdominal pain [Efficacy] [ Time Frame: 3 months ]

    Proportion of monthly responders during month 1, during month 1 through 2 and during month 1 through 3 determined from the subjects' daily assessments of IBS symptoms, bloating, and abdominal pain; relief of IBS symptoms and bloating is defined as a score of either 0 (not at all) or 1 (hardly) for at least 50% of the days in a given month or a score of 0 (not at all), 1 (hardly), or 2 (somewhat) for 100% of the days in a given month. Relief of abdominal pain is defined as a decrease by ≥30% from baseline in weekly mean rating of IBS-related abdominal pain. Relief of stool consistency is defined as a 50% or greater reduction in the number of days per month with at least one stool that has a consistency of Type 6 or 7 compared with baseline.

    Daily Assessments:

    • IBS Symptoms: Scored between 0 (Not bothersome at all) and 6 (a very great deal bothersome)
    • Bloating: Scored between 0 (not at all bothersome) and 6 (a very great deal bothersome)

  10. Change from baseline to each week during follow up for IBS-symptoms bloating, abdominal pain, stool consistency, urgency - captured by a daily diary [Efficacy] [ Time Frame: 12 weeks ]

    Change from baseline to each week during the 12 week follow up for daily IBS symptoms, bloating, abdominal pain, stool consistency and sense of urgency, asked as "Have you felt or experienced a sense of urgency today? [Yes/No]" and calculated as 100* (number of days with urgency/number of days with data), and daily number of stools. This information will be captured in a daily diary by the participants.

    All participants will complete daily assessments of IBS symptoms, bloating and abdominal pain:

    • IBS Symptoms: Scored between 0 (Not bothersome at all) and 6 (a very great deal bothersome)
    • Bloating: Scored between 0 (not at all bothersome) and 6 (a very great deal bothersome)
    • Stool Consistency: Bristol Stool Scale (Scored 1-7)
    • Urgency: Answered Yes or No

  11. Change from baseline at weeks 4, 8 and 12 in quality of life assessment [Efficacy] [ Time Frame: 12 weeks ]
    Change from baseline at weeks 4, 8 and 12 in quality of life inquired as IBS-QoL


Other Outcome Measures:
  1. Treatment Emergent Adverse Events [Safety] [ Time Frame: 12 weeks ]
    Monitoring of treatment emergent adverse events.

  2. Change from Baseline in Physical Exam [Safety] [ Time Frame: 12 weeks ]
    Changes from baseline in physical examination.

  3. Change from Baseline in Vital Signs [Safety] [ Time Frame: 12 weeks ]
    Changes from baseline in vital signs.

  4. Change from Baseline in Lab Tests [Safety] [ Time Frame: 12 weeks ]
    Changes from baseline in clinical laboratory tests.

  5. Change from Baseline in ECG [Safety] [ Time Frame: 12 weeks ]
    Changes from baseline in ECG.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

    1. abdominal pain score ≥3 using an 11-point numeric rating scale and
    2. bloating score: 2-4 inclusive and
    3. 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:

    4. "In the past 7 days, have you had adequate relief of your IBS symptoms?" [No] and
    5. "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:

  1. Hormonal oral, implantable, transdermal, or injectable contraceptives for at least 2 months before the screening visit
  2. 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:

  3. Male condoms with spermicide

    Reliable methods of contraception for both women and men include:

  4. 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

Exclusion Criteria:

  1. IBS: symptoms of constipation at baseline:

    1. less than 3 bowel movements a week and
    2. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03099785


Contacts
Contact: R Jones ++35318170381 rjones@cosmopharma.com
Contact: Emma O'Shea ++35318170381 EOShea@cosmopharma.com

Locations
Belgium
University Hospital Gasthuisberg, Department of Gastroenterology Recruiting
Leuven, Herestraat 49, Belgium, 3000
Contact: Jan Tack       jan.tack@med.kuleuven.be   
Principal Investigator: Jan Tack         
St Lukas Ziekenhuis, Recruiting
Brugge, Lucaslaan 29, Belgium, 8310
Contact: Joris Arts       joris.arts@stlucas.be   
Principal Investigator: Joris Arts         
Department of Gastroenterology, Erasme Hospital, 808 Route de Lennik Recruiting
Brussels, Belgium, B-1070
Contact: Hubert Louis, MD       Hubert.Louis@erasme.ulb.ac.be   
Principal Investigator: Hubert Louis         
Clinique universitaires Saint-Luc Gastroenterologie Route 606 Avenue Hippocrate, 10 Recruiting
Bruxelles, Belgium, 1200
Contact: Hubert Piessevaux       hubert.piessevaux@uclouvain.be   
Principal Investigator: Hubert Piessevaux         
Maria Middelares, Digestief Centrum, Buitenring St-Denijs 30 Recruiting
Gent, Belgium, 9000
Contact: Sebastien Kindt, MD       sebastien.kindt@azmmsj.be   
Principal Investigator: Sebastien Kindt         
University Hospital Gent, Depintelaan 185 Recruiting
Gent, Belgium, 9000
Contact: Danny De Looze, MD       danny.delooze@ugent.be   
Principal Investigator: Danny De Looze         
Germany
Internistenzentrum Bahnhofstrasse 30 Recruiting
Gauting, Germany, 82131
Contact: Martin Storr, MD    0049 89 8931093    m.storr@internistenzentrum.de   
Principal Investigator: Martin Storr         
Gastroenterologie, Interventionelle Endoskopie, Diabetologie und Akutgeriatrie, KRH-Zentrumsgeschaftsfuhrer innere Medizin, KRK Klinikum Siloah-Oststadt-Heidehaus Stadionbrucke 4 Recruiting
Hannover, Germany, 30459
Contact: Ahmed Madisch    0049 511 9272100    ahmed.madisch@krh.eu   
Principal Investigator: Ahmed Madisch         
AmBeNet GmbH, Wilhelm-Leuschner-Platz I2, Recruiting
Leipzig, Germany, 04107
Contact: Hans-Detlev Stahl, MD    0049 341 35582000    dshome@ambenet.de   
Principal Investigator: Hans-Detlev Stahl         
Universitatsklinikum Magdeburg A.O.R. Klinik fur Gastroenterologie, Hepatologie und Infektiologie, Leipziger Str.44 Recruiting
Magdeburg, Germany, 39120
Contact: Ulrike von Arnim, MD    0049 391 6713151    ulrike.vonarnim@med.ovgu.de   
Principal Investigator: Ulrike von Arnim         
Italy
S.O.C Gastroenterologia Oncologica Recruiting
Aviano, PN, Italy, 233081
Contact: Renato Cannizzaro, MD    +39-0434659281/275    rcannizzaro@cro.it   
Principal Investigator: Renato Cannizzaro         
Azienda Ospedaliera G. Brotzu, U.O. di Gastroenterelogia, Via Peretti Recruiting
Cagliari, Italy, 09100
Contact: Paolo Usai-Satta, MD    070 53 93 09    paolousai@aob.it   
Principal Investigator: Paolo Usai-Satta         
Istituto Clinico Humanitas, Centro Malattie Infiammatorie Croniche Intestinali Recruiting
Milano, Italy, 20089
Contact: Silvio Danese       silvio.danese@humanitas.it   
Principal Investigator: Silvio Danese, MD         
Fonazione IRCCS Ospedale Maggiore Recruiting
Milano, Italy, 20122
Contact: G Basilisco, MD    02 55033736    basilisc@policlinico.mi.it   
Principal Investigator: Guido Basilisco         
Azienda Ospedaliero-Universitaria di Parma, Amb. Fisiopatologia Digestiva Recruiting
Parma, Italy, 14
Contact: Anna Bertele, MD    0521702641    abertele@ao.pr.it   
Principal Investigator: Anna Bertele         
Fondazione IRCCS Policlinico S. Matteo, Dip Area Medica: Medicina Generale 1, Viale Camillo Golgi, 19 Recruiting
Pavia, Italy, 27100
Contact: Michele Di Stefano, MD    0382 502975    m.distefano@smatteo.pv.it   
Principal Investigator: Michele Di Stefano         
Polo Scienze Gastroenterologiche ed Recruiting
Roma, Italy, 00168
Contact: Guido Costamagna, MD       guido.costamagna@unicatt.it   
Principal Investigator: Guido Costamagna         
Universita Campus Bio Medico, U.O.C di Gastroenterologia ed Endoscopia Digestiva Recruiting
Roma, Italy, 21
Contact: Michele PL Guarino    3386932101    M.Guarino@unicampus.it   
Principal Investigator: Michele PL Guarino         
IRCCS Policlinico San Donato, Medicina Generale III- Gastroenterologia Recruiting
San Donato Milanese, Italy, 20097
Contact: Luca Pastorelli, MD         
Principal Investigator: Maurizio Vecchi         
Spain
Hospital Universitari Germans Trias i Pijol (Can Ruti). Servicio de Aparto Digestivo Carretera de Canyet, s/n Recruiting
Badalona, Barcelona, Spain, 08916
Contact: Jordi Serra       jserrap.germanstrias@gencat.cat   
Principal Investigator: Jordi Serra         
Hospital Universitario La Paz, Servicio de Aparato Digestivo Po de la Castellana 261 Recruiting
Castellana, Madrid, Spain, 28046
Contact: Silvia Gomez Senent, MD         
Principal Investigator: Silvia Gomez Senent         
Hospital Universitario Ramon Y Cajal, Servicio de Gastroenterologia y Hepatologia Ctra. de colmenar Viejo, Km 9,100 Recruiting
Colmenar Viejo, Madrid, Spain, 28034
Contact: Carlos Teruel, MD       cteruelvegazo@yahoo.es   
Principal Investigator: Carlos Teruel         
Centro Medico Teknon, Servicio de Aparato Digestivo, Carrer de Vilana 12 Recruiting
Barcelona, Spain, 08022
Contact: Fermin Mearin, MD       mearin@dr.teknon.es   
Principal Investigator: Fermin Mearin         
Hospital Universitari vall d'Hebron, Servicio de Aparato Digestivo, Passeig Vall d'Hebron, 119-129 Recruiting
Barcelona, Spain, 08035
Contact: Javier Santos    934894035 ext 4035    javier.santos@vhir.org   
Principal Investigator: Javier Santos         
Hospital Universitario Clinico San Carlos, Servicio de Aparato Digestivo, Calle del Prof Martin Lagos, s/n, Recruiting
Madrid, Spain, 28040
Contact: Enrique R Diaz Rubio, MD       enrique.rey@salud.madrid.org   
Principal Investigator: Enrique Diaz Rubio         
Fundacion de Investigacion Biomedica Hospital 12 de Octubre, Hospital Universitario 12 de Octubre, Servicio de Apartato Digestivo, Avenda de Cordoba s/n Recruiting
Madrid, Spain, 28041
Contact: Constanza Ciriza de los Rios, MD       constanzacarpa@gmail.com   
Principal Investigator: Constanza Ciriza de los Rios         
Sponsors and Collaborators
Cosmo Technologies Ltd

Responsible Party: Cosmo Technologies Ltd
ClinicalTrials.gov Identifier: NCT03099785     History of Changes
Other Study ID Numbers: CB-01-11/28
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: None. IPD not to be shared.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Syndrome
Diarrhea
Irritable Bowel Syndrome
Disease
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Rifamycins
Rifamycin SV
Anti-Bacterial Agents
Anti-Infective Agents
Antirheumatic Agents