sodium hydrogen carbonate; sodium dihydrogen phosphate for Chronic constipation

Inclusion criteria

• {"criterion_text":"- Patients of both sexes aged 18 years and older\n- Reliable contraception during participation in the clinical trial\n- Patients with and without limited walking ability/mobility (at least wheelchair mobility); in the case of paraplegia, however, only paraplegic patients\n- 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\n- Signed consent to participation and to the collection and pseudonymised forwarding of personal data\n- Negative pregnancy test for women of childbearing potential at visit 1\n- Discontinuation of previous therapy for constipation (if applicable)\n- Agreement to avoid changes in lifestyle and dietary habits during the study period\n- Willingness to keep a patient diary in accordance with regulations\n- Patients whose symptoms of chronic constipation could not be sufficiently improved by conservative treatment (such as fluid intake, exercise, high-fibre diet)"}

Exclusion criteria

• {"criterion_text":"- Uncooperative patients\n- Taking medication for constipation during the clinical trial (except emergency medication Glycilax®)\n- Pregnant patients\n- 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)).\n- Known hypersensitivity to soy, peanuts or any of the other ingredients of Lecicarbon® E CO2 laxative.\n- Patients with secondary constipation (endocrine and metabolic diseases, medications (including opioids))\n- Patients with tetraplegic paraplegia\n- Any physical or mental limitations that significantly restrict the performance of the study procedures\n- Patients with ileus (intestinal obstruction) or megacolon\n- Clinically significant (as assessed by the investigator) history of cancer as well as cardiovascular, liver, lung, endocrine, neurological or psychiatric diseases or metabolic disorders\n- Patients unable to give informed consent\n- Patients who do not have sufficient command of the German language (informed consent form)\n- Patients who are dependent on the sponsor, investigator, other study personnel or the study centre"}

Primary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"Measured using the CHMP guideline-specific tool 'complete spontaneous bowel movements' (CSBM), documented prospectively in patient diaries to assess tolerability, safety and compliance."}

Secondary endpoints

• {"endpoint_text":"- Prospective documentation of ‘constipation symptoms’ (PAC-SYM) and ‘quality of life’ (PAC-QOL)","definition_or_measurement_approach":"Measured using patient-reported instruments PAC-SYM (constipation symptoms) and PAC-QOL (quality of life)."}

Germany

Earliest CTIS Part Ii Submission Date

04-08-2025

Latest Decision Or Authorization Date

31-03-2026

Processing Time Days

239

Number Of Sites

4

Number Of Participants

100

Primary sponsor

Full Name

Athenstaedt GmbH & Co. KG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Germany

Third parties

• {"country":"Germany","full_name":"Mediconomics GmbH","duties_or_roles":"Codes: 1,10,11,12,2,3,5,6,7","organisation_type":"Pharmaceutical company"}