Evaluation of the Safety and Tolerability of Long-Term Sodium Hydrogen Carbonate and Sodium Dihydrogen Phosphate Treatment in Chronic Constipation Patients

The primary objective of this clinical study is to evaluate the **safety** and **tolerability** of long-term treatment with Lecicarbon® in patients with **chronic constipation**. This is clinically relevant as chronic constipation is a common gastrointestinal disorder that can significantly impact a patient's quality of life. Ensuring the safety and tolerability of Lecicarbon® for long-term use is crucial for providing a reliable therapeutic option for managing this condition. There are no secondary objectives listed for this study.

The clinical trial focuses on evaluating the safety and tolerability of long-term treatment with **Lecicarbon®** in patients diagnosed with **chronic constipation**. The study population includes both male and female participants aged 18 years and older. Participants may have limited walking ability or mobility, including those with paraplegia, provided they have wheelchair mobility. The trial does not involve a vulnerable population. Participants are required to have a diagnosis of chronic constipation, characterized by two or fewer bowel movements per week, and must exhibit additional symptoms such as very hard stools, a feeling of incomplete evacuation, or straining to defecate, persisting for at least six months. The trial population was selected based on these criteria, and participants are expected to maintain their current lifestyle and dietary habits throughout the study. The sponsor has not provided information regarding the total number of participants involved in the trial.

The clinical trial is designed to evaluate the **safety** and tolerability of long-term treatment with Lecicarbon® E CO2-Laxans in patients with chronic constipation. This study is a randomized, double-blind, controlled trial, ensuring that neither the participants nor the researchers know who is receiving the treatment or placebo, thus minimizing bias. The trial is expected to commence on August 1, 2025, and conclude by August 1, 2026, with an estimated duration of 12 months. Participants will be involved for a maximum treatment period of 4 weeks, with the possibility of early termination if adverse effects are observed or if the participant withdraws consent.

The study will include an initial screening visit to confirm eligibility based on criteria such as age, diagnosis of chronic constipation, and agreement to maintain lifestyle and dietary habits. Participants must have a diagnosis of chronic constipation, defined as two or fewer bowel movements per week, and meet additional symptom criteria over a period of at least 6 months. A negative pregnancy test is required for women of childbearing potential. Following the screening, participants will undergo regular follow-up visits to monitor safety, tolerability, and compliance, using tools such as the 'complete spontaneous bowel movements' (CSBM) and patient diaries. The primary endpoint is the documentation of tolerability and safety, while secondary endpoints include the assessment of constipation symptoms and quality of life.

The end-of-study visit will involve a comprehensive evaluation of the participant's response to the treatment and any adverse events experienced. Participants are expected to adhere to the study protocol, including the use of the investigational product as a **suppository** for rectal use, with a maximum daily dose of two units and a total dose not exceeding 56 units. Conditions that may lead to early termination include non-compliance with the study protocol, withdrawal of consent, or the occurrence of significant adverse events. The trial aims to provide valuable data on the long-term use of Lecicarbon® E CO2-Laxans in managing chronic constipation.

The clinical trial involves the use of the experimental medication **Lecicarbon® E CO2-Laxans**, which is formulated as a **suppository**. This medication contains the active substances **sodium hydrogen carbonate** and **sodium dihydrogen phosphate**, both of which are of chemical origin. The pharmaceutical form is specifically designed for **rectal use**. The maximum daily dosage is set at two suppositories, with a total maximum dose of 56 suppositories over the course of the treatment period. The treatment duration is limited to a maximum of four weeks. The medication is manufactured by ATHENSTAEDT GMBH & CO KG and is classified under the ATC code A06AX02, which pertains to carbon dioxide-producing drugs.

In this study, no non-experimental treatments such as standard-of-care therapy, placebo, or comparator treatments are utilized. The focus is solely on evaluating the safety and tolerability of Lecicarbon® E CO2-Laxans in patients with chronic constipation. Participant compliance with the dosing schedule is monitored throughout the trial to ensure adherence to the prescribed regimen. The trial does not include a pediatric formulation, and the medication is not classified as an orphan drug. The study aims to provide comprehensive data on the long-term use of this treatment in the specified patient population.

Efficacy in the clinical trial evaluating Lecicarbon® E CO2-Laxans for the treatment of chronic constipation will be assessed using both primary and secondary endpoints. The primary endpoint involves the prospective documentation of tolerability, safety, and compliance of the treatment, specifically focusing on the occurrence of **complete spontaneous bowel movements** (CSBM). This will be documented in patient diaries, adhering to the recommended CHMP guideline-specific tool.

Secondary endpoints include the prospective documentation of constipation symptoms using the Patient Assessment of Constipation Symptoms (PAC-SYM) scale and the assessment of quality of life through the Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire. These tools will provide a comprehensive evaluation of the treatment's impact on symptom relief and overall patient well-being. Data collection will be conducted throughout the trial duration, with specific timepoints for assessment not explicitly detailed in the provided information.