Clinical study to evaluate the safety and tolerability of long-term treatment with Lecicarbon® in patients with chronic constipation

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Athenstaedt 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

9 Sep 2025 → ongoing

Decision date (initial)

2025-08-06

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy

Clinical study to evaluate the safety and tolerability of long-term treatment with Lecicarbon® in patients with chronic constipation

Conditions and MedDRA coding

Treatment of chronic constipation

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. Patients of both sexes aged 18 years and older
2. Patients with and without limited walking ability/mobility (at least wheelchair mobility); in the case of paraplegia, however, only paraplegic patients
3. Patients with a diagnosis of chronic constipation defined as two or fewer bowel movements per week (bowel movements not preceded within 24 hours by the use of laxatives or enemas leading to a feeling of complete evacuation) and at least one or more of the following symptoms over a period of at least 6 months: very hard or hard stools at least 25% of the time; feeling of incomplete evacuation after at least 25% of the stools; straining to defecate at least 25% of the time
4. Signed consent to participation and to the collection and pseudonymised forwarding of personal data
5. Negative pregnancy test for women of childbearing potential at visit 1
6. Discontinuation of previous therapy for constipation (if applicable)
7. Agreement to avoid changes in lifestyle and dietary habits during the study period
8. Willingness to keep a patient diary in accordance with regulations
9. Patients whose symptoms of chronic constipation could not be sufficiently improved by conservative treatment (such as fluid intake, exercise, high-fibre diet)
10. Reliable contraception during participation in the clinical trial

Exclusion criteria 13

1. Uncooperative patients
2. Patients with secondary constipation (endocrine and metabolic diseases, medications (including opioids))
3. Patients with tetraplegic paraplegia
4. Any physical or mental limitations that significantly restrict the performance of the study procedures
5. Patients with ileus (intestinal obstruction) or megacolon
6. Clinically significant (as assessed by the investigator) history of cancer as well as cardiovascular, liver, lung, endocrine, neurological or psychiatric diseases or metabolic disorders
7. Patients unable to give informed consent
8. Patients who do not have sufficient command of the German language (informed consent form)
9. Patients who are dependent on the sponsor, investigator, other study personnel or the study centre
10. Taking medication for constipation during the clinical trial (except emergency medication Glycilax®)
11. Pregnant patients
12. Patients who have undergone relevant operations in the gastrointestinal tract (surgical procedures affecting the intestine, such as intestinal resection, rectopexy, hernia operations and pelvic floor surgery, or intestinal surgery such as partial removal of the intestine and STARR surgery (stapled transanal rectal resection)).
13. Known hypersensitivity to soy, peanuts or any of the other ingredients of Lecicarbon® E CO2 laxative.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Prospective documentation of tolerability, safety and compliance of Lecicarbon® E CO2 laxative in chronic constipation using the recommended CHMP guideline-specific tool ‘complete spontaneous bowel movements’ (CSBM), documented in patient diaries

Secondary endpoints 1

1. Prospective documentation of ‘constipation symptoms’ (PAC-SYM) and ‘quality of life’ (PAC-QOL)

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Athenstaedt GmbH & Co. KG

Sponsor organisation

Athenstaedt GmbH & Co. KG

Address

Am Beerberg 1

City

Battenberg (Eder)

Postcode

35088

Country

Germany

Scientific contact point

Organisation

Athenstaedt GmbH & Co. KG

Contact name

athenstaedt GmbH

Public contact point

Organisation

Athenstaedt GmbH & Co. KG

Contact name

athenstaedt GmbH

Third parties 1

Locations

1 EU/EEA country · 4 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

Documents 4 files

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

Application history

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