In short
Clinical trials investigating SODIUM DIHYDROGEN PHOSPHATE are studying its use in people with chronic constipation. These studies look at safety, tolerability, and how well treatment is followed over time. The goal is to see how it performs in patients who need long-term care.
Key points
- Clinical trials investigating SODIUM DIHYDROGEN PHOSPHATE are focused on chronic constipation. The available study is a Phase 3 interventional trial with 100 planned participants. It is looking at long-term treatment safety, tolerability, and compliance. The main outcome uses complete spontaneous bowel movements, or CSBM, which are recorded in patient diaries. The trial is authorised and is designed for patients with chronic constipation.
Trial overview
The available study is a Phase 3 clinical trial of SODIUM DIHYDROGEN PHOSPHATE in people with chronic constipation. It is an interventional study, which means participants receive the study treatment as part of the research. The trial is designed to evaluate long-term treatment, with a focus on safety, tolerability, and compliance.
Study population and who may take part
The target population is patients with chronic constipation. The trial record does not give more detailed inclusion or exclusion rules, so the source only shows that the study is meant for this condition.
- Chronic constipation means a long-lasting problem with bowel movements.
- The study is meant for people who need long-term management of this condition.
Study design and phase
The study is in Phase 3, which is a later stage of clinical testing. Phase 3 trials usually look at how a treatment performs in a larger group of patients and help gather more information before wider use. In this trial, the planned enrollment is 100 patients.
The study status is Authorised, meaning it has been approved to begin. The intervention listed is Lecicarbon® E CO2-Laxans, given by rectal use, but the trial is presented in the data as a study of SODIUM DIHYDROGEN PHOSPHATE.
What the trial measures
The main outcome is complete spontaneous bowel movements, also called CSBM. A spontaneous bowel movement is one that happens naturally, without extra rescue help. The trial uses patient diaries to record this outcome, along with tolerability, safety, and compliance.
- Safety checks whether the treatment can be used without major problems in the study group.
- Tolerability looks at how well patients can continue the treatment over time.
- Compliance means how well patients follow the study plan, including diary recording and treatment use.
- Patient diaries help collect daily study information directly from participants.
Trial status and size
The trial is currently listed as Authorised. The planned enrollment is 100 participants, which gives the study a moderate-sized group for this phase. The brief summary confirms that the study is focused on long-term treatment in chronic constipation.
What the results may mean for patients
This research is trying to learn whether SODIUM DIHYDROGEN PHOSPHATE can be used safely and comfortably over a longer period in people with chronic constipation. The study is not mainly about short-term relief; it is about ongoing treatment and how patients do with it in real study conditions. The use of CSBM and patient diaries shows that the trial is measuring both bowel movement patterns and day-to-day treatment experience.