A clinical study to determine how effective Menthacarin is for patients with Irritable Bowel Syndrome, and to determine the possible side effects of the product.

Phase 1

• Conditions: 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: 20.1Level: PTClassification code 10023003Term: Irritable bowel syndromeSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

• Registration Number: EUCTR2014-004702-14-DE
• Lead Sponsor: Dr. Willmar Schwabe GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-30
• Last Update Posted: 26 November 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

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 < 25 points
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 160
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified