Diarrhea-predominant Irritable Bowel SyndromePhase 2NCT03099785
Rifamycin SV-MMX® 600 mg Tablets Administered Three or Two Times Daily to Patients With IBS-D
A Phase 2 study testing Rifamycin SV 600mg t.i.d. in people with Diarrhea-predominant Irritable Bowel Syndrome, run by Cosmo Technologies Ltd at 29 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diarrhea-predominant Irritable Bowel Syndrome
- What is being tested?
- Rifamycin SV 600mg t.i.d.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 279 participants
- Where
- 29 sitesin 4 countries
- Study dates
- 18 Dec 2017to 14 Dec 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed Consent: signed written informed consent before inclusion in the study
- 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
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- 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
- 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:
- Male condoms with spermicide
- Reliable methods of contraception for both women and men include:
- 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
Who cannot join
- 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
- Intolerance: ascertained underlying lactose intolerance with response to diet or any other malabsorption syndrome with the exclusion of asymptomatic lactose malabsorption
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- 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
- Investigational drugs: participation in the evaluation of any investigational product within 30 days before this study
- 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
- Pregnancy (females only): pregnant or lactating women or wishing to become pregnant in the 3 months following this visit
Trial locations and contacts
29 sites in 4 countries.
29 sites in 4 countries
Germany11 sites
Emovis GmbH Wilmersdorfer Straße 79
Berlin, 10629
Unterfrintroper Hausarztzentrum Lehrpraxis der Universität Essen
Essen, 45359
Internistenzentrum Bahnhofstrasse 30
Gauting, 82131
Clinical Research Hamburg GmbH, Rahlstedter Bahnhofstraße 33
Hamburg, 22143
Gastroenterologie, Interventionelle Endoskopie, Diabetologie und Akutgeriatrie, KRH-Zentrumsgeschaftsfuhrer innere Medizin, KRK Klinikum Siloah-Oststadt-Heidehaus Stadionbrucke 4
Hanover, 30459
Gemeinschaftspraxis Dr. Klein & J. Minnich
Künzing, 94550
AmBeNet GmbH, Wilhelm-Leuschner-Platz I2,
Leipzig, 04107
Universitatsklinikum Magdeburg A.O.R. Klinik fur Gastroenterologie, Hepatologie und Infektiologie, Leipziger Str.44
Magdeburg, 39120
Ärztehaus Reinfeld Praxisgemeinschaft für Allgemeinmedizin Klosterstraße 7
Reinfeld, 23858
Innomed Dr. med. Naudts Ludwig-Erhard-Platz 11
Rodgau, 63110
Internistische Praxisgemeinschaft, Bereich Gastroenterologie Hauptstraße. 51
Weyhe, 28844
Italy8 sites
S.O.C Gastroenterologia Oncologica
Aviano, PN, 233081
Azienda Ospedaliera G. Brotzu, U.O. di Gastroenterelogia, Via Peretti
Cagliari, 09100
Istituto Clinico Humanitas, Centro Malattie Infiammatorie Croniche Intestinali
Milan, 20089
Fonazione IRCCS Ospedale Maggiore
Milan, 20122
Fondazione IRCCS Policlinico S. Matteo, Dip Area Medica: Medicina Generale 1, Viale Camillo Golgi, 19
Pavia, 27100
Polo Scienze Gastroenterologiche ed
Roma, 00168
Universita Campus Bio Medico, U.O.C di Gastroenterologia ed Endoscopia Digestiva
Roma, 21
IRCCS Policlinico San Donato, Medicina Generale III- Gastroenterologia
San Donato Milanese, 20097
Belgium5 sites
St Lukas Ziekenhuis,
Bruges, Lucaslaan 29, 8310
Clinique universitaires Saint-Luc Gastroenterologie Route 606 Avenue Hippocrate, 10
Brussels, 1200
Maria Middelares, Digestief Centrum, Buitenring St-Denijs 30
Ghent, 9000
University Hospital Gent, Depintelaan 185
Ghent, 9000
University Hospital Gasthuisberg, Department of Gastroenterology
Leuven, Herestraat 49, 3000
Spain5 sites
Hospital Universitari Germans Trias i Pijol (Can Ruti). Servicio de Aparto Digestivo Carretera de Canyet, s/n
Badalona, Barcelona, 08916
Hospital Universitari vall d'Hebron, Servicio de Aparato Digestivo, Passeig Vall d'Hebron, 119-129
Barcelona, 08035
Hospital Universitario La Paz, Servicio de Aparato Digestivo Po de la Castellana 261
Castellana, Madrid, 28046
Hospital Universitario Ramon Y Cajal, Servicio de Gastroenterologia y Hepatologia Ctra. de colmenar Viejo, Km 9,100
Colmenar Viejo, Madrid, 28034
Hospital Universitario Clinico San Carlos, Servicio de Aparato Digestivo, Calle del Prof Martin Lagos, s/n,
Madrid, 28040
About this study
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)
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.
- Being tested
- Rifamycin SV 600mg t.i.d., Rifamycin SV b.i.d. + Placebo, Placebo t.i.d.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rifamycin SV 600mg t.i.d.Drug
Morning: one 600 mg tablet Afternoon: one 600 mg tablet Evening: one 600 mg tablet
Rifamycin SV b.i.d. + PlaceboDrug
Morning. one 600 mg tablet Afternoon: one matching placebo tablet Evening: one 600 mg tablet
Placebo t.i.d.Drug
Morning. one matching placebo tablet Afternoon: one matching placebo tablet Evening: one matching placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| Treatment group 1: dose regimen 1 | Active comparator | Rifamycin SV-MMX® 600 mg modified release tablets, three times daily (t.i.d.) Receives: 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.) Receives: Drug: Rifamycin SV b.i.d. + Placebo |
| Treatment group 3: matching placebo | Placebo comparator | Rifamycin SV-MMX® matching placebo tablets, t.i.d. Receives: Drug: Placebo t.i.d. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 88 days
Secondary outcomes (11)
Proportion of subjects with relief of global IBS symptoms during weeks 3-12 [Efficacy]
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]"
Measured: 10 weeks
Proportion of subjects with monthly relief of global IBS symptoms [Efficacy]
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.
Measured: 88 days
Proportion of subjects with relief of IBS-related bloating during weeks 3-12 [Efficacy]
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]."
Measured: 10 weeks
Proportion of subjects with monthly relief of IBS-related bloating [Efficacy]
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.
Measured: 88 days
Proportion of subjects with weekly relief of IBS symptoms, bloating and abdominal pain [Efficacy]
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)
Measured: 88 days
Number of weeks of IBS-symptom relief during follow-up [Efficacy]
Number of weeks (consecutive or not) subjects achieve adequate relief of IBS symptoms during the follow up period.
Measured: 10 weeks
Number of weeks of bloating relief during follow-up [Efficacy]
Number of weeks (consecutive or not) subjects achieve adequate relief of bloating during the follow up period.
Measured: 10 weeks
Change in IBS-symptoms, bloating and abdominal pain from baseline to 12 weeks - captured by a daily diary [Efficacy]
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)
Measured: 12 weeks
Proportion of monthly responders for IBS-symptoms, bloating and abdominal pain [Efficacy]
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)
Measured: 3 months
Change from baseline to each week during follow up for IBS-symptoms bloating, abdominal pain, stool consistency, urgency - captured by a daily diary [Efficacy]
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
Measured: 12 weeks
Change from baseline at weeks 4, 8 and 12 in quality of life assessment [Efficacy]
Change from baseline at weeks 4, 8 and 12 in quality of life inquired as IBS-QoL
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start18 Dec 2017
- Primary completion11 Sep 2020
- Study completion14 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diarrhea-predominant Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 279 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cosmo Technologies Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03099785
- Sponsor's protocol ID
- CB-01-11/28
- Status last verified
- Jan 2021
- First submitted
- 14 Mar 2017
- Last updated
- 8 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: None. IPD not to be shared.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03099785
- Acronym / sponsor ID
- CB-01-11/28
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 279 participants (actual)
- Lead sponsor
- Cosmo Technologies LtdIndustry (pharma, biotech, devices)
- Study start
- 18 Dec 2017 (actual)
- Primary completion
- 11 Sep 2020 (actual)
- Study completion
- 14 Dec 2020 (actual)
- First posted
- 4 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment group 1: dose regimen 1 | Active comparator | Drug: Rifamycin SV 600mg t.i.d.Rifamycin SV-MMX® 600 mg modified release tablets, three times daily (t.i.d.) |
| Treatment group 2: dose regimen 2 | Active comparator | Drug: Rifamycin SV b.i.d. + PlaceboRifamycin SV-MMX® 600 mg modified release tablets, two times daily (b.i.d.) + matching placebo daily (q.d.) |
| Treatment group 3: matching placebo | Placebo comparator | Drug: Placebo t.i.d.Rifamycin SV-MMX® matching placebo tablets, t.i.d. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Informed Consent: signed written informed consent before inclusion in the study
- 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:
- 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:
Key exclusion criteria (19 listed)
- IBS: symptoms of constipation at baseline:
- 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
- Intolerance: ascertained underlying lactose intolerance with response to diet or any other malabsorption syndrome with the exclusion of asymptomatic lactose malabsorption
- Coeliac disease: ascertained or presumptive underlying coeliac disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rifamycin SV 600mg t.i.d.Morning: one 600 mg tablet Afternoon: one 600 mg tablet Evening: one 600 mg tablet | Drug | Treatment group 1: dose regimen 1 |
| Rifamycin SV b.i.d. + PlaceboMorning. one 600 mg tablet Afternoon: one matching placebo tablet Evening: one 600 mg tablet | Drug | Treatment group 2: dose regimen 2 |
| Placebo t.i.d.Morning. one matching placebo tablet Afternoon: one matching placebo tablet Evening: one matching placebo tablet | Drug | Treatment group 3: matching placebo |
Primary outcome
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)
11 secondary outcomes
Proportion of subjects with relief of global IBS symptoms during weeks 3-12 [Efficacy]
Time frame: 10 weeks
Proportion of subjects with monthly relief of global IBS symptoms [Efficacy]
Time frame: 88 days
Proportion of subjects with relief of IBS-related bloating during weeks 3-12 [Efficacy]
Time frame: 10 weeks
Proportion of subjects with monthly relief of IBS-related bloating [Efficacy]
Time frame: 88 days
Proportion of subjects with weekly relief of IBS symptoms, bloating and abdominal pain [Efficacy]
Time frame: 88 days
Number of weeks of IBS-symptom relief during follow-up [Efficacy]
Time frame: 10 weeks
Number of weeks of bloating relief during follow-up [Efficacy]
Time frame: 10 weeks
Change in IBS-symptoms, bloating and abdominal pain from baseline to 12 weeks - captured by a daily diary [Efficacy]
Time frame: 12 weeks
Proportion of monthly responders for IBS-symptoms, bloating and abdominal pain [Efficacy]
Time frame: 3 months
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 at weeks 4, 8 and 12 in quality of life assessment [Efficacy]
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2021.
- Individual participant dataSharing planned: No. None. IPD not to be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
29 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rifamycin SV 600mg t.i.d. in people with Diarrhea-predominant Irritable Bowel Syndrome, run by Cosmo Technologies Ltd at 29 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Germany, Italy, Belgium, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with relief from abdominal pain and improved stool consistency. (time frame: 88 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2021.