A clinical trial to investigate efficacy and safety of Menthacarin® in patients (at least 18 years old) suffering from symptoms of Irritable Bowel Syndrome (IBS)

Not Applicable

Completed

• Conditions: Irritable bowel syndrome (IBS); Digestive System

• Registration Number: ISRCTN31630783
• Lead Sponsor: Dr. Willmar Schwabe GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-05-17
• Study Completion: 2019-03-31
• Last Update Posted: 6 July 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 226

Inclusion Criteria

1. Aged 18 years and over
2. Provision of written informed consent in accordance with the legal requirements
3. Willing and able to comply with all study procedures
4. Diagnosis of irritable bowel syndrome (IBS) based on the following criteria:
4.1. Presence of IBS symptoms (e.g. abdominal pain, flatulence) for > 3 months
4.2. IBS symptoms are ascribed by both patient and physician to the gut and usually accompanied by altered bowel habits
4.3. The IBS complaints are the reason, why the subject consulted the physician
4.4. No changes characteristic of other diseases are present that are likely to be the cause of the symptoms
5. Numeric Rating Scale (NRS) assessing severity of pain > 3 points at visit 1 and visit 2, respectively
6. 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
7. IBS-Severity Scoring System (IBS-SSS) > 80 points at visit 1 and 2, respectively
8. Any reduction in IBS-SSS at visit 2 in comparison to visit 1 is < 25 points

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 at least 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Abdominal pain is measured using an 11 point numeric rating scale (NRS) between day -10 and day 28 (daily), according to the assessment of the patient as a part of the patient’s diary.<br> The primary outcome will be the change in abdominal pain at day 28 in comparison to day 0 (weekly average of the patient’s diary data) between Menthacarin groups and placebo groups.<br>