Table of contents
- Trial overview
- Digestive symptom trial
- Cancer-related constipation trial
- Other cancer studies in the data
- Main endpoints and what they mean
- Who the studies are for
Trial overview
The trial data include four interventional studies that mention Magnesium Hydroxide or a closely named form of it, with uses that range from digestive symptom care to constipation prevention in advanced cancer.[1][3] The studies are in Phase 3, Phase 2, and Low Intervention designs, and their status is either Completed or Authorised.[1][2][3][4]
These trials do not all study the same condition. Some focus on heartburn, reflux, and functional dyspepsia, while others focus on patients with advanced cancer, including those starting opioids for pain treatment.[1][3]
Digestive symptom trial
The PEPPER trial, NCT05629143, is a completed Phase 3 study with 745 participants and looks at heartburn, functional dyspepsia, and reflux.[1] It compares different strategies for people who are chronically using proton pump inhibitors, which are medicines often used for acid-related symptoms.[1]
The study tested three approaches: on-demand PPI use, replacement of PPI therapy with an alginate formulation, and gradual dose reduction using fixed intermittent intake.[1] The trial wanted to see which deprescribing strategy, meaning a planned way to reduce or stop medicine use, worked best for patients without a clear need for long-term PPI treatment.[1]
The main outcome was the percentage of randomized patients who achieved a successful therapeutic outcome by the end of follow-up.[1] This outcome combined three patient-reported points: use of PPI, treatment satisfaction, and willingness to continue with the treatment.[1]
Cancer-related constipation trial
The study with ID 2023-509462-38-00 is an authorised Low Intervention trial in 250 patients with advanced cancer.[3] It studies prevention of opioid-induced constipation, which means constipation caused by opioid pain medicines.[3]
This trial compares Magnesiumhydroxide Teva 724 mg with Movicolon Naturel 13,7 g to show whether Magnesium Hydroxide is not worse than the comparison treatment for preventing constipation.[3] The study starts in patients who are beginning opioids for pain, so the target group is very specific.[3]
The primary endpoint is constipation, defined as the percentage of patients with a Bowel Function Index score below 30 on day 14.[3] In simple terms, the study checks how many patients do not develop constipation after two weeks of treatment.[3]
Other cancer studies in the data
Two other trials in the data are cancer studies, but they focus on SKB264 rather than Magnesium Hydroxide as the main study drug.[2][4] They are included here because the source data list Magnesium Hydroxide-related products among the intervention records, but the study purpose is about cancer treatment, not digestive symptom care.[2][4]
NCT04152499 is a completed Phase 2 study in 1,261 patients with metastatic or locally advanced unresectable solid tumors that had progressed after standard therapies.[2] Its main endpoint was objective response rate, which means the percentage of patients who had a complete or partial tumor response by RECIST 1.1, a standard way to measure tumor change on scans.[2]
NCT05816252 is an authorised Phase 2 study in 498 patients with advanced or metastatic non-small cell lung cancer.[4] It evaluates safety, tolerability, dose-limiting toxicity, adverse events, treatment discontinuation due to adverse events, and objective response rate.[4]
Main endpoints and what they mean
In the digestive symptom trial, the main endpoint is a patient-based measure of treatment success, not just symptom relief alone.[1] The study combines medicine use, satisfaction, and willingness to continue, which helps show whether the strategy fits real-life patient needs.[1]
In the cancer constipation trial, the key endpoint is the Bowel Function Index score at day 14.[3] A score below 30 is used to define constipation outcomes in this study, so the trial is focused on a clear bowel function target.[3]
In the lung cancer study, the endpoints include dose-limiting toxicity and adverse events, which are ways to track whether treatment causes side effects that limit use.[4] The study also measures objective response rate, which tells researchers how many patients have tumor shrinkage or disappearance on imaging.[4]
Who the studies are for
The trial populations are quite different across studies.[1][3][4] One study is for people with heartburn, functional dyspepsia, and reflux who are using PPIs long term without a clear long-term reason.[1]
Another study is for people with advanced cancer who are starting opioids for pain and need help preventing constipation.[3] The cancer treatment studies involve people with advanced or metastatic solid tumors, including non-small cell lung cancer.[2][4]
Because these studies have different goals, the people who can join are also different.[1][3][4] This is important because clinical trials are usually designed for a very specific group, not for everyone.[1]
