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

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-522464-32-00

Acronym

ATS_9711

Enrollment

100

Registered

2025-08-06

Start date

2025-09-09

Completion date

Unknown

Last updated

2025-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment of chronic constipation

Brief summary

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

Detailed description

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

Interventions

DRUGLecicarbon® E CO2-Laxans

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Secondary

Measure	Time frame
Prospective documentation of ‘constipation symptoms’ (PAC-SYM) and ‘quality of life’ (PAC-QOL)	—

Primary

Measure	Time frame
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	—

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026