Table of contents
- Trial overview
- Study populations and conditions
- Trial phases and what they mean
- Main endpoints measured in the trials
- Trial status and study size
- How to read these trial records
Trial overview
The trial records provided for this article do not show a study directly testing Anhydrous Caffeine. Instead, they describe several clinical trials of other treatments in cancer, autoimmune disease, and chronic pain.[1][2][3]
These studies are interventional trials, which means researchers give a treatment and then measure what happens.[1][2]
Study populations and conditions
Several trials focus on people with lymphoma, including Hodgkin lymphoma, non-Hodgkin lymphoma, follicular lymphoma, marginal zone lymphoma, and indolent non-Hodgkin lymphoma.[1][7]
Other studies include adults with systemic lupus erythematosus (SLE), which is a long-term autoimmune disease where the immune system attacks the body’s own tissues.[4][5]
One Phase 3 study includes people with rheumatoid arthritis, a disease that causes joint inflammation and pain.[6]
Another study looks at multiple myeloma, a cancer of plasma cells, and one Phase 3 trial studies chronic pain due to diabetic polyneuropathy, which is nerve pain related to diabetes.[5][2]
One basket study includes several solid tumors: endometrial cancer, cervical cancer, prostate cancer, urothelial carcinoma, and ovarian cancer.[3]
Trial phases and what they mean
The data includes Phase 1/2, Phase 2, and Phase 3 studies.[1][2][3]
Phase 1/2 studies usually begin with safety checks and early testing of whether a treatment may work.[1]
Phase 2 studies often look for early proof of benefit in a specific disease group, while still watching safety closely.[3][5][7]
Phase 3 studies are larger and are used to confirm benefit and safety in bigger patient groups.[2][4][5]
Main endpoints measured in the trials
In the lymphoma Phase 1/2 study, the main safety outcome was the number of dose-limiting toxicities, which are side effects serious enough to stop dose increases, along with the number and severity of adverse events.[1]
The same study also measured overall response rate using Lugano criteria, which are rules doctors use to judge how well lymphoma responds to treatment.[1]
In the diabetic polyneuropathy pain study, the main outcome was change in pain score on the Numeric Rating Scale from baseline to week 14.[2]
The basket study in solid tumors measured safety by counting dose-limiting toxicities, adverse events, and treatment stops due to side effects, and it measured efficacy by complete or partial response and, in prostate cancer, changes in prostate-specific antigen, a protein made by the prostate gland.[3]
The lupus study at Week 48 used the BICLA response, a composite score that combines several signs of disease improvement.[4]
The long-term lupus study measured treatment-emergent adverse events, serious adverse events, and adverse events that led to permanent treatment discontinuation.[5]
The rheumatoid arthritis study measured change in DAS28-CRP at Week 12, which is a score showing how active the arthritis is based on joints and inflammation markers.[6]
The multiple myeloma imaging study measured sensitivity, meaning how well the scan found true disease lesions, by comparing results with other imaging, follow-up, or histology, which is tissue examination under a microscope.[5]
The indolent non-Hodgkin lymphoma study measured objective response rate over a long follow-up period of up to 15 years.[7]
Trial status and study size
Some records are marked Completed, which means the study has finished collecting data.[1][2][5][6][7]
Other records are marked Authorised, which means the study has been approved and is not listed as completed in the provided data.[3][4]
Enrollment ranged from 45 people in the multiple myeloma imaging study to 765 people in the long-term lupus study.[5][5]
How to read these trial records
When reading a trial record, the most useful parts are the condition being studied, the phase, the number of participants, and the main outcome being measured.[1][2][3]
If a study lists safety outcomes, it means researchers are checking for unwanted medical problems during the trial.[1][5]
If a study lists response, pain score, or disease activity, it means researchers are trying to see whether the treatment helps the condition being studied.[1][2][4][6][7]
