Confirmed diagnosis of diarrhea-dominant irritable bowel syndrome (IBS-D) by a specialist physician and/or internal medicine and/or general medicine MedDRA version: 26.0 Level: LLT Classification code 10060845 Term: Diarrhea predominant irritable bowel syndrome System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Trade Name: MYRRHINIL-INTEST®
Pharmaceutical Form: Coated tablet
INN or Proposed INN: myrrh powder
CAS Number: 9000-45-7
Other descriptive name: MYRRH
Concentration unit: mg milligram(s)
Concentrati
Sponsors
Repha GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Patients of both sexes aged =18 and = 75 years •confirmed IBS-D diagnostic to visit 1 •performed colon examination (coloscopy) by patients > 55 years within the last 5 years before study participation • stool frequency: before visit 1 (screening) in the last 7 days on at least 3 days 1 watery stool/day •Evaluation of the IBS-D symptoms: o NRS pain > 3 points at visit 1 and visit 2 o stool consistency documented by the patient using the Bristol stool form scale to visit 1 and 2 •Stool sample analysis for exclusion of blood in stool (faecal occult blood) and exclusion of Clostridium difficile infection by Glutamate-dehydrogenase- (GDH-) ELISA by inclusion in the study (results at visit 2) •Presence of an informed consent signed by the patient •Understanding that changes in lifestyle and eating habits are avoided during the study period •Willingness to keep a regular patient diary •Negative pregnancy test for childbearing persons 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 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: shortened due to character limit: a) Diseases 1. confirmed diagnosis of microscopic colitis, ulcerative colitis or Crohn's disease 2. confirmed diagnosis of constipation subtype IBS (IBS-C), mixed-type IBS (IBS-M) or undefined IBS (IBS-U) 3. Since disease: weight loss in the last 6 months (clinically significant, at the investigator's discretion), nocturnal symptoms, anamnesis by first degree relatives with colon carcinoma 4. suspicion of acute appendicitis 5. if stool tests have been performed in the previous 6 months prior to inclusion in the study: - positive test for blood in stool (except for admixtures due to hemorrhoids or traces of blood due to local irritation due to frequent defecation) - positive test for parasites and worm eggs - clinically relevant increased calprotectin values (> 50 µg/g) in stool 6. diagnosed infectious gastroenteritis 7. known anomalies of the gastrointestinal tract (e.g. megacolon) or known diseases resulting in an altered gastrointestinal passage (e. g. colonic polyps) 8. liver or kidney dysfunction (serum creatinine, serum AST or ALT at least 3 times above the reference value in the last 12 months prior to inclusion in the study and during the study) 9. patients with known or suspected gallbladder inflammation (cholecystitis), gallstones, bile acid malabsorption, obstruction of the bile ducts or other gallbladder diseases, sphincter oddi dysfunction or abdominal adhesions 10. past or suspected pancreatitis, ileus or gastrointestinal bleeding 11. endometriosis 12. patients with gastroesophageal reflux disease (GERD) above 2b 13. known or suspected other reasons for diarrhoea: celiac disease; fructose, lactose, sorbitol intolerance or other intolerances 14. patients with malignant diseases or cancer treatments of the gastrointestinal tract in the last 5 years, as well as all other areas of the body in the last 2 years before inclusion in the study with continuing risk potential 15. known autoimmune diseases in the gastrointestinal tract 16. immunocompromised patients 17. condition after partial colon resections 18. diabetes mellitus, type I and/or type II 19. inappropriate medication setting with known hyper- or hypothyroidism, Hashimoto's thyroiditis or signs of thyroid dysfunction 20. hypersensitivity to chamomile, other daisies, myrrh, coffee charcoal, chamomile flowers or one of the other components of the test medication or the placebo. 21. hereditary problems of fructose / galactose intolerance, glucose-galactose malabsorption or sucrase isomaltase insufficiency 22. Serious somatic/psychosomatic, neurological and/or psychiatric conditions diagnosed and making it difficult for the patient to make an informed decision about consent to participate in the clinical trial b) Medication (shortened due to character limit) 1. taking neuroleptics 2. taking antibiotics 3. taking of systemic corticosteroids 4. taking medication to treat IBS-D (exception of study medication and emergency medication) 5. continued use of NSAID for more than 14 days (except for low-dose NSAID for thrombosis prevention or treatment of AEs) 6. intake of opioid till 1 month before study start and during study participation 7. intake of cardiac glycosides c) General anamnesis 1. patients who participated or are participating (screening) in other clinical trials 30 days prior to the initial inclusion examination or during the clinical trial, or who previously participated in the same trial (randomization) 2. patients with a dis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Demonstration of efficacy, safety and tolerability of MYRRHINILINTEST® versus placebo in the treatment of diarrhea-dominant irritable bowel syndrome (IBS-D);Secondary Objective: • Change stool frequency • Number of spontaneous bowel movements • Stool consistency • Number of incidences of the feeling of incomplete defecation • Occurrence of mucus and / or blood in the stool • IBS-D symptom severity assessment using the IBS-Severity Scoring System (IBS-SSS) • Quality of life assessment • Global assessement of the efficiency by the investigator and the patient at visit 3-6 (4-point scale) • Reduced use of emergency medication (Buscopan®) within day 0 to 28 while treating the symptoms of IBS-D and while treatment phase 1 • Compliance (amount of consumed study medication) at visit 3-6 via documentation in the patient diary • Compliance (amount of consumed study medication) via drug accountability at visit 4 and 6;Primary end point(s): Efficacy will be assessed by a co-primary endpoint defined by the responder criteria: 1) A response of abdominal pain is required (NRS pain): A responder is defined as a patient who has a decrease in abdominal pain of at least 30% in the 2-week control period at the end of treatment phase 1 from the value in the 2-week screening phase before randomisation. 2) Furthermore, an assessment of stool consistency is also required (Bristol Stool Shape Scale): A responder with regard to stool consistency is defined as a patient who, in the 2-week control period at the end of treatment phase 1, shows a decrease in the number of days with at least one stool of consistency 6 or 7 by at least 50% compared to the screening phase.;Timepoint(s) of evaluation of this end point: Comparison between two co primary end points within the 14 days of treatment 1 compared to the last 14 days within screening: • Alteration of stool consistency based on the number of stools with consistency of type 7 (aqueous, without solid ingredients) or type 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy: •Change in stool frequency in the last 14 days of treatment phase 1 compared to the 14 days of the screening phase, each measured as total number of stools. Target parameter is the reduction: Frequency pre - Frequency post •Number of spontaneous bowel movements, daily based on the patient's entries in the patient diary •Stool consistency measured by the Bristol Stool form Scale survey, daily entry in the patient diary, query at visits 1-6 at the trial center •Number of incidences of the feeling of incomplete defecation daily based on the patient's entries in the patient's diary •Occurrence of mucus and / or blood in the stool, daily entry in the patient diary, query at the visits 1-6 at the trial center •IBS-D symptom severity assessment using the IBS-Severity Scoring System (IBS-SSS) at visits 1-5 (visit survey: completed by the patient) •Quality of life assessment via the IBS-QoL questionnaire at visits 1-6 (visit survey: completed by the patient) •Global assessment of efficacy by investigator and patient at visits 3 - 6 (4-point scale) •Minimum use of emergency medication (Buscopan®) within day 0-28 within the treatment against the symtomes of IBS-D and within treatment phase 1 •Compliance (amount of consumed study medication) at visits 3-6 via entry in the patient's diary •Compliance (amount of consumed study medication) on presence visits 4 and 6 via drug accountability ;Timepoint(s) of evaluation of this end point: • Alteration of the stool frequency •Number of spontaneous bowel movements: daily entry in the patient's diary •Stool consistency: daily entry in the patient's diary, V1 to V6 •Number of incidences of the feeling of incomplete defecation: daily entry in the patient's diary •Occurrence of mucus and / or blood in the stool: daily entry in the patient's diary, V1 to V6 •IBS-D symptom severity assessment, V1 to V5 •Quality of life assessment, V1 to V6 •Global assessment of efficacy, V3 to V6 •Minimum use of emergency me | — |
Countries
Germany
Contacts
Public ContactClinical Research Project Manager
Mediconomics GmbH
Outcome results
None listed