Menthacarin® in the treatment of functional gastrointestinal disorders

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Dr. Willmar Schwabe GmbH & Co. KG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

15 May 2023 → 17 Jan 2024

Decision date (initial)

2023-03-30

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

Dr. Willmar Schwabe GmbH & Co. KG, Willmar-Schwabe-Str. 4, 76227 Karlsruhe, Germany

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

The objectives are to systematically assess symptom changes and tolerability during treatment with Menthacarin and to explore their impact on quality of life and treatment satisfaction in a broad population of patients with functional gastrointestinal disorders. Furthermore, parameters related to gut permeability will be determined.

Conditions and MedDRA coding

functional gastrointestinal disorders

Study design 2 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Adult male or female subject (≥18 years old)
2. Written informed consent in accordance with the legal requirements is voluntarily provided by the patient prior to the beginning of any trial-related tasks or investigations
3. Patient with willingness and ability to comply with all trial procedures and to attend all scheduled visits at the investigational site
4. Patient suffering from a functional gastrointestinal disorder: Patient suffers from at least one of the following functional abdominal symptoms at least 1 day/week for ≥ 3 months on: - abdominal pain/cramping - bloating feeling
5. The presence of at least one of the functional abdominal symptoms - abdominal pain/cramping - bloating feeling - postprandial fullness with an intensity of ≥ 4 points on a 0-10 points numeric rating scale (NRS) on at least one day within the last week prior to visit 1 (assessed retrospectively at visit 1)
6. At visit 2 only: At least one of the functional abdominal symptoms - abdominal pain/cramping - bloating feeling - postprandial fullness assessed already at visit 1 with an intensity of ≥ 4 points on a 0-10 NRS, was present on at least one day within the last week prior to visit 2 with an intensity of ≥ 4 points on a 0-10 NRS (documented by daily diary assessment).

Exclusion criteria 20

1. Patient in whom abdominal symptoms are caused by an organic cause.
2. Patient with constipation and/or changes in bowel movements alternating between normal bowel movements and constipation
3. Evidence of structural abnormality of the gastrointestinal tract or diseases/conditions that affect bowel transit
4. Patient is currently experiencing bloody diarrhoea
5. Known hypersensitivity to peppermint, menthol, caraway, to umbelliferous plants or other ingredients of the investigational medicinal product
6. Concomitant use of any other treatments for functional gastrointestinal disorders, including herbal preparations (other than the investigational medicinal product)
7. Patient is suffering from reduced production of gastric acid (achlorhydria)
8. Liver diseases
9. Gallstones, inflammation of the bile duct (cholangitis) or other diseases of the gall
10. Patient is immunocompromised (e.g. AIDS, lymphoma, long-term corticosteroid treatment).
11. Patient with a malignant disease or undergoing chemotherapy or radiation therapy
12. Patient with known or suspected history of alcohol or drug abuse according to the opinion of the investigator
13. Female patient who is pregnant, breast-feeding or planning pregnancy during the course of this clinical trial
14. Female patient of child-bearing potential not using or not willing to use consistently and correctly throughout the duration of this clinical trial one of the following contraceptive methods: established use of implants, injectables, or combined hormonal oral, intravaginal or transdermal contraceptives, placement of an intrauterine device (IUD) or intrauterine hormone-releasing system (IUS), sexual abstinence and vasectomised partner
15. Patient exhibiting or indicating thoughts of suicide currently or in the past
16. Planned surgical intervention during the clinical trial
17. Previous inclusion in the present clinical trial
18. Patient participating in another clinical trial at the same time, or has taken part in a clinical trial within the last 30 days before inclusion in the present clinical trial
19. Patient unable to read and / or write
20. Patient who are members of the staff of the trial site, staff of the sponsor or involved Clinical Research Organizations (CROs), the investigator him- / herself or close relatives of the investigator

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 14

1. Symptom rating by the patient using 11-point numeric rating scales,
2. The sum of patient symptom rating of all abdominal symptoms,
3. Global question on symptom impact,
4. Most bothersome abdominal symptom,
5. Stool frequency via Frequency of Spontaneous Bowel Movements (SBMs),
6. Stool consistency via Bristol Stool Scale,
7. Satisfaction with change in bowel habits,
8. Global assessment of effectiveness, on a 5-point Likert scale
9. Patient´s satisfaction using the Integrative Medicine Patient Satisfaction Scale (IMPSS),
10. Quality of Life Questionnaire (SF 12),
11. Patient’s willingness to recommend Menthacarin,
12. Serum parameters: Zonulin and Intestinal-fatty acid binding protein (I-FABP)
13. Adverse events
14. Global assessment of tolerability on a 5-point Likert scale

Secondary endpoints 1

1. Due to the character of the trial, no differentiation in primary and secondary outcome variables is intended

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Dr. Willmar Schwabe GmbH & Co. KG

Sponsor organisation

Dr. Willmar Schwabe GmbH & Co. KG

Address

Willmar-Schwabe-Straße 4, Durlach Durlach

City

Karlsruhe

Postcode

76227

Country

Germany

Scientific contact point

Organisation

Dr. Willmar Schwabe GmbH & Co. KG

Contact name

Annette Waßmer

Public contact point

Organisation

Dr. Willmar Schwabe GmbH & Co. KG

Contact name

Annette Waßmer

Third parties 3

Locations

1 EU/EEA country · 11 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 2 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications