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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
279
Morning: one 600 mg tablet Afternoon: one 600 mg tablet Evening: one 600 mg tablet
Morning. one 600 mg tablet Afternoon: one matching placebo tablet Evening: one 600 mg tablet
Morning. one matching placebo tablet Afternoon: one matching placebo tablet Evening: one matching placebo tablet
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)
Time frame: 88 days
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? \[Yes/No\]"
Time frame: 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.
Time frame: 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? \[Yes/No\]."
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University Hospital Gasthuisberg, Department of Gastroenterology
Leuven, Herestraat 49, Belgium
St Lukas Ziekenhuis,
Bruges, Lucaslaan 29, Belgium
Clinique universitaires Saint-Luc Gastroenterologie Route 606 Avenue Hippocrate, 10
Brussels, Belgium
Maria Middelares, Digestief Centrum, Buitenring St-Denijs 30
Ghent, Belgium
University Hospital Gent, Depintelaan 185
Ghent, Belgium
Emovis GmbH Wilmersdorfer Straße 79
Berlin, Germany
Unterfrintroper Hausarztzentrum Lehrpraxis der Universität Essen
Essen, Germany
Internistenzentrum Bahnhofstrasse 30
Gauting, Germany
Clinical Research Hamburg GmbH, Rahlstedter Bahnhofstraße 33
Hamburg, Germany
Gastroenterologie, Interventionelle Endoskopie, Diabetologie und Akutgeriatrie, KRH-Zentrumsgeschaftsfuhrer innere Medizin, KRK Klinikum Siloah-Oststadt-Heidehaus Stadionbrucke 4
Hanover, Germany
...and 19 more locations
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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)
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]
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
Time frame: 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
Time frame: 12 weeks