Symptoms of Irritable Bowel Syndrome (IBS) characterized by recurrent abdominal pain, abdominal discomfort, abdominal cramping, abdominal fullness, abdominal bloating or flatulence usually accompanied by altered bowel habits MedDRA version: 20.1 Level: PT Classification code 10023003 Term: Irritable bowel syndrome System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Trade Name: Carmenthin® bei Verdauungsstörungen
Product Name: Menthacarin
Product Code: WS® 1340 / WS® 1520
Pharmaceutical Form: Gastro-resistant capsule, soft
INN or Proposed INN: Not Applicable
Curr
Sponsors
Dr. Willmar Schwabe GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult male or female subject (=18 years old) 2. Subject provided a written informed consent in accordance with the legal requirements 3. Subject with willingness and ability to comply with all study procedures 4. Subjects with a diagnosis of irritable bowel syndrome (IBS) based on the following criteria: 5. Presence of IBS symptoms (e.g. abdominal pain, flatulence) for > 3 months 6. IBS symptoms are ascribed by both patient and physician to the gut and usually accompanied by altered bowel habits 7. The IBS complaints are the reason, why the subject consulted the physician 8. No changes characteristic of other diseases are present that are likely to be the cause of the symptoms 9. Numeric Rating Scale (NRS) assessing severity of pain > 3 points at visit 1 and visit 2, respectively 10. Any reduction in numeric pain rating scale (NRS) assessing severity of pain at visit 2 not greater than one point in comparison to visit 1 11. IBS-Severity Scoring System (IBS-SSS) > 80 points at visit 1 and 2, respectively 12. Any reduction in IBS-SSS at visit 2 in comparison to visit 1 is =65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: 1. History of chronic or evident acute liver, heart, respiratory tract, pulmonary, muscular (e.g. M. gravis) or renal disease 2. History or suspected glaucoma (angel-closure glaucoma) 3. Subjects with a history of urinary retention by mechanical narrowing of the urinary tract (e.g. enlarged prostate) 4. History of renal or hepatic dysfunction (serum creatinine, serum AST or ALT = 3 folds above the upper limit of normal range or alkaline phosphatase > 2 fold above the upper limit of normal) within the last 12 months prior to inclusion into the study 5. Subject with known or suspected gall bladder inflammation (cholangitis), is suffering from gall stone, occlusion of the bile ducts or other diseases of the gall bladder, sphincter Oddi dysfunction, or abdominal adhesions 6. History or suspected pancreatitis, ileus, or any gastrointestinal bleeding 7. Female subject suffering from endometriosis 8. Subject is immune-compromised (e.g. AIDS, lymphoma, long-term corticosteroid treatment) 9. Subject with malignant tumours or undergoing chemotherapy or radiation therapy 10. Evidence of structural abnormality of the gastrointestinal tract or diseases/conditions that affect bowel Transit (e. g. mega-colon) 11. Subject is suffering from gastro-oesophageal reflux disease (GERD) or reduced production of gastric acid (achlorhydria) 12. Evident or suspected other causes for diarrhoea such microscopic colitis, celiac disease 13. Subject is currently experiencing nausea, fever > 38.5 °C (measured using an infrared ear thermometer), vomiting, or bloody diarrhoea 14. Subject with history of a gastrointestinal surgery (except appendectomy conducted before one year or longer) 15. Subject with clinically significant abnormal results of laboratory tests at the time point of visit 1 (including haematology tests, serum chemistry tests, thyroid function tests) 16. Subject is 50 years or older who has been diagnosed with IBS and has not received a colonoscopy in the last 6 months prior to inclusion into the study 17. Subject with history of positive test of blood in stool within the last 6 months prior to inclusion into the study 18. Subject with history of clinically relevant increase in stool calprotectin within the last 6 months prior to inclusion into the study 19. Subject using or has used antipsychotic, antidepressive or anticholinergic medication within one month prior to inclusion into the study 20. Previous (within the last 14 days) or concomitant use of analgesics, prokinetics, sedatives, laxatives, anti-diarrhoeal agents, steroidal agents, antacids, proton-pump inhibitors, anti-coagulants, antibiotics or probiotics 21. Known or suspected hypersensitivity to the investigational drug or to one of its excipients or to peppermint, menthol, caraway, or to umbelliferous plants or to the rescue medication (BUSCOPAN® PLUS) offered in the study or one of its excipients 22. Previous (within the last 30 days) or current use of medications for the treatment of IBS (including herbal preparations) 23. Women with positive pregnancy test at visit 1 24. Pregnant or breast-feeding women 25. Female subject is currently not using an acceptable form of birth control or does not agree to maintain its use throughout the study 26. Subject exhibiting or indicating thoughts of suicide currently or in the past 27. Subject with no willingness and no ability to comply with all procedures of the trial and is not able to attend all scheduled visits at the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy and tolerability of Menthacarin® in patients (= 18 years old) suffering from symptoms of IBS. ;Secondary Objective: Not Applicable;Primary end point(s): Change in abdominal pain (using an 11 point numeric rating scale (NRS)) at the time points of visit 4 in comparison to the time point of visit 2 (baseline), according to the assessment of the patient between Menthacarin (groups A1+A2) and placebo (groups B1+B2);Timepoint(s) of evaluation of this end point: Visits 2 and 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Change in abdominal pain (using an 11 point numeric rating scale (NRS)), according to the assessment of the patient 2) Change in further abdominal symptoms, i.e. abdominal discomfort, abdominal cramping, abdominal fullness, and abdominal bloating (using an 11 point numeric rating scale (NRS)) 3) Change in Clinical Global Impression (Severity) (CGI-S) 4) Change in Clinical Global Impression (Change) (CGI-C) 5) Change in IBS global assessment of improvement (IBS-GAI) 6) IBS Quality of Life Questionnaire (IBS-QOL) 7) Change in Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) 8) Frequency of Spontaneous Bowel Movements (SBMs) 9) Change in bowel habits 10) Time point of first perceived abdominal symptom improvement after randomisation (assessed by the patient during the double-blind treatment phase) 11) Patient´s satisfaction with the randomized treatment using the Integrative Medicine Patient Satisfaction Scale (IMPSS) (assessed by the patient during the double-blind treatment phase) 12) Use of BUSCOPAN® PLUS film-coated tablets 13) Adverse events 14) Laboratory parameters 15) Vital signs 16) Global assessment of tolerability by investigator and patient;Timepoint(s) of evaluation of this end point: 1) NRS Change in abdominal pain - Visits 2, 3, 4, 5 & 6 2) NRS Change in abdominal symptoms - Visits 2, 3, 4, 5 & 6 3) CGI-S Visits 2, 3, 4, 5 & 6 4) CGI-C Visits 3, 4, 5 & 6 5) IBS-GAI Visits 3, 4, 5 & 6 6) IBS-QOL Visits 2, 4, 5 & 6 7) IBS-SSS Visits 2, 3, 4, 5 & 6 8) SBMs - Visits 2, 3, 4, 5 & 6 - daily assessment by Patient 9) Change in bowel habits - Visits 2, 3, 4, 5 & 6 10) Timepoint of first perceived - Visits 2 - 4 - daily assessment by patient 11) IMPSS - Visits 3, 4 12) Use of BUSCOPAN® PLUS - Visit 6 13) AEs - During the whole trial period 14) Labs - Visit 1, 4, 5 & 6 15) Vital signs - Visit 1, 2, 3, 4, 5 & 6 16) Global assessment of tolerability - Visits 3, 4, 5 & 6 | — |
Countries
Germany
Contacts
Public ContactProject Director
Dr. Willmar Schwabe GmbH & Co. KG
Outcome results
None listed