In short
Meglumine indometacin is a nonsteroidal anti-inflammatory drug (NSAID) that reduces pain and inflammation. It is authorised as a medicine and appears in one European clinical trial as a comparator in axial spondyloarthritis, a chronic inflammatory condition of the spine. The trial is a Phase 3 study with 100 participants.
Meglumine indometacin is a nonsteroidal anti-inflammatory drug (NSAID). It is a chemically synthesised substance that is authorised as a medicine in the European Union. In the clinical trial data examined here, it appears as a comparator treatment for axial spondyloarthritis.
Key points
- Phase 3 trial in axial spondyloarthritis with 100 participants.
- Indometacin is used as a comparator, not the main study drug.
- The trial compares NSAIDs with a biosimilar TNF blocker.
- The main measure is low disease activity (ASDAS <2.1) after 12 weeks.
- Indometacin is an authorised medicine for several inflammatory conditions.
- Trial status: Authorised.
What is meglumine indometacin?
Meglumine indometacin is a nonsteroidal anti-inflammatory drug (NSAID). It is a chemically synthesised substance, meaning it is made in a laboratory rather than derived from a living organism. The substance is classified as indometacin with ATC code M01AB01. It is authorised as a medicine, and the product name recorded in the trial registry is INDOMETACIN.
How does meglumine indometacin work?
Indometacin belongs to the NSAID class of medicines. NSAIDs work by reducing the production of substances in the body called prostaglandins, which are involved in pain, inflammation and fever. The US label for indometacin capsules describes the medicine as a nonsteroidal anti-inflammatory drug. The label also warns that NSAIDs as a class can increase the risk of serious cardiovascular and gastrointestinal events.
Which conditions is meglumine indometacin used or studied for?
- Moderate to severe rheumatoid arthritis — including acute flares of chronic disease.
- Moderate to severe ankylosing spondylitis — a form of axial spondyloarthritis.
- Moderate to severe osteoarthritis — a condition where joint cartilage wears down.
- Acute painful shoulder — including bursitis and tendinitis.
- Acute gouty arthritis — a sudden, painful form of joint inflammation.
- Axial spondyloarthritis — the condition studied in the European trial, where indometacin serves as a comparator.
How is meglumine indometacin given?
Indometacin is taken by mouth. The trial record lists the route of administration as oral. The NHS dm+d browser lists many oral forms, including capsules, modified-release capsules, modified-release tablets, oral solutions and oral suspensions, as well as suppositories. In the European trial, indometacin is given as a 150 mg oral dose.
What do the clinical trials show?
One European trial, identified as 2024-513213-13-00, includes meglumine indometacin. The trial is a Phase 3 interventional study in axial spondyloarthritis with 100 participants. Its status is Authorised.
In this trial, indometacin is a comparator. The study directly compares NSAIDs with a biosimilar TNF blocker called Remsima in patients with axial spondyloarthritis who have failed NSAID therapy in outpatient care. The NSAID arm includes several medicines: diclofenac, indometacin, ibuprofen, acemetacin, etoricoxib, meloxicam, celecoxib and naproxen.
The primary outcome is the proportion of patients on NSAID versus TNF blocker treatment who achieve low disease activity, defined as ASDAS below 2.1, after 12 weeks of treatment. ASDAS stands for Ankylosing Spondylitis Disease Activity Score, a measure of disease activity in axial spondyloarthritis.
What side effects are known?
The prescribing information for indometacin capsules carries a boxed warning about serious risks. NSAIDs, including indometacin, can increase the risk of serious cardiovascular thrombotic events such as myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.
NSAIDs can also increase the risk of serious gastrointestinal adverse events, including bleeding, ulceration and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease or gastrointestinal bleeding are at greater risk.
Indometacin capsules are contraindicated in the setting of coronary artery bypass graft (CABG) surgery.