Table of contents
- Trial overview
- Study population and who may take part
- Study design and phase
- What the trial measures
- Trial status and size
- What the results may mean for patients
Trial overview
The available study is a Phase 3 clinical trial of SODIUM DIHYDROGEN PHOSPHATE in people with chronic constipation.[1] It is an interventional study, which means participants receive the study treatment as part of the research.[1] The trial is designed to evaluate long-term treatment, with a focus on safety, tolerability, and compliance.[1]
Study population and who may take part
The target population is patients with chronic constipation.[1] 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.[1]
Chronic constipation means a long-lasting problem with bowel movements.[1]
The study is meant for people who need long-term management of this condition.[1]
Study design and phase
The study is in Phase 3, which is a later stage of clinical testing.[1] Phase 3 trials usually look at how a treatment performs in a larger group of patients and help gather more information before wider use.[1] In this trial, the planned enrollment is 100 patients.[1]
The study status is Authorised, meaning it has been approved to begin.[1] 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.[1]
What the trial measures
The main outcome is complete spontaneous bowel movements, also called CSBM.[1] A spontaneous bowel movement is one that happens naturally, without extra rescue help.[1] The trial uses patient diaries to record this outcome, along with tolerability, safety, and compliance.[1]
Safety checks whether the treatment can be used without major problems in the study group.[1]
Tolerability looks at how well patients can continue the treatment over time.[1]
Compliance means how well patients follow the study plan, including diary recording and treatment use.[1]
Patient diaries help collect daily study information directly from participants.[1]
Trial status and size
The trial is currently listed as Authorised.[1] The planned enrollment is 100 participants, which gives the study a moderate-sized group for this phase.[1] The brief summary confirms that the study is focused on long-term treatment in chronic constipation.[1]
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.[1] The study is not mainly about short-term relief; it is about ongoing treatment and how patients do with it in real study conditions.[1] The use of CSBM and patient diaries shows that the trial is measuring both bowel movement patterns and day-to-day treatment experience.[1]
