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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2014-004702-14
    Sponsor's Protocol Code Number:530079.01.302
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-11-30
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2014-004702-14
    A.3Full title of the trial
    Efficacy and Tolerability of Menthacarin in Patients (≥ 18 years old) suffering from symptoms of Irritable Bowel Syndrome (IBS)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    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.
    A.4.1Sponsor's protocol code number530079.01.302
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorDr. Willmar Schwabe GmbH & Co. KG
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportDr. Willmar Schwabe GmbH & Co. KG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDr. Willmar Schwabe GmbH & Co. KG
    B.5.2Functional name of contact pointProject Director
    B.5.3 Address:
    B.5.3.1Street AddressWillmar-Schwabe-Str. 4
    B.5.3.2Town/ cityKarlsruhe
    B.5.3.3Post code76227
    B.5.3.4CountryGermany
    B.5.4Telephone number497214005645
    B.5.5Fax number4972140058645
    B.5.6E-mailberenike.stracke@schwabe.de
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Carmenthin® bei Verdauungsstörungen
    D.2.1.1.2Name of the Marketing Authorisation holderDr. Willmar Schwabe GmbH & Co KG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMenthacarin
    D.3.2Product code WS® 1340 / WS® 1520
    D.3.4Pharmaceutical form Gastro-resistant capsule, soft
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot Applicable
    D.3.9.2Current sponsor codeWS® 1340
    D.3.9.3Other descriptive nameEssential oil of Mentha x piperitae L.
    D.3.9.4EV Substance CodeSUB12550MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot Applicable
    D.3.9.2Current sponsor codeWS® 1520
    D.3.9.3Other descriptive nameEssential oil of Carum carvi
    D.3.9.4EV Substance CodeSUB34998
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product Yes
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product Yes
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboGastro-resistant capsule, soft
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    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
    E.1.1.1Medical condition in easily understood language
    Abdominal pain, bloating and altered bowel habits
    E.1.1.2Therapeutic area Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10023003
    E.1.2Term Irritable bowel syndrome
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy and tolerability of Menthacarin® in patients (≥ 18 years old) suffering from symptoms of IBS.
    E.2.2Secondary objectives of the trial
    Not Applicable
    E.2.3Trial contains a sub-study No
    E.3Principal 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
    E.4Principal 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 investigational site
    28. Participation in a further clinical trial at the same time or within the last 3 months prior to inclusion into the present study
    29. Previous randomisation in the present clinical study
    30. Subject with known or suspected history of alcohol or drug abuse according to the opinion of the investigator
    31. Subjects who’s participate in the clinical trial results in an unjustifiable impairment of their well-being according to the opinion of the investigator
    32. Planned surgical intervention during the clinical study
    E.5 End points
    E.5.1Primary 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)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visits 2 and 4
    E.5.2Secondary 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
    E.5.2.1Timepoint(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
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned30
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    End of trial is defined as date of clean data (August 2018)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 160
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state200
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Normal treatment of that condition
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-04-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-06-15
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