In short
Methylcellulose is a chemically synthesised substance given by mouth, authorised as a medicine and classified as a bulking laxative (ATC code A06AC06). In the clinical trial data provided, it appears not as the medicine under study but as the placebo arm of a Phase 3 trial comparing propranolol with placebo in 600 adults with traumatic brain injury admitted to intensive care. The trial measures whether 14 days of treatment changes how many patients die in hospital.
Methylcellulose is a chemically synthesised substance that is given by mouth. In the product record it is described as an oral solution, and it is authorised as a medicine. In the clinical trial listed on this page, methylcellulose is used as the placebo, the comparison arm that contains no active medicine, rather than as the treatment being studied.
Key points
- Methylcellulose is a bulking laxative authorised as a medicine and given by mouth.
- In the trial record it is the placebo, not the treatment being investigated.
- The trial is a Phase 3 randomised, triple-blind study.
- It enrolled 600 adults with traumatic brain injury in intensive care.
- The main outcome is hospital mortality after 14 days of treatment.
What is methylcellulose?
Methylcellulose is a chemically synthesised substance. It is authorised as a medicine and is given by mouth. In the product information it appears as an oral solution, for example a 100 mg/5 ml oral solution. Its ATC code is A06AC06, the class of bulk-forming laxatives, which work by increasing the volume of the stool. In the trial record, the product name is simply methylcellulose, and its role is listed as placebo in one trial.
How does methylcellulose work?
Methylcellulose is a bulk-forming laxative. It absorbs water in the bowel, which increases the volume and softness of the stool. This is the mechanism of the A06AC06 class to which it belongs. The trial record does not describe a mechanism of action for methylcellulose because it is used there only as the placebo arm.
Which conditions is methylcellulose used or studied for?
The product information lists methylcellulose as a laxative, which is its authorised use. In the trial data it is not studied for a condition of its own; it is the placebo in a study of traumatic brain injury, also called head injury.
How is methylcellulose given?
Methylcellulose is given by mouth. The product record describes an oral solution, and the trial lists the oral route for the placebo arm.
What do the clinical trials show?
There is one clinical trial in the data, and in it methylcellulose is the placebo. The trial is a Phase 3, prospective, randomised, triple-blind study called ProP TBI in ICU. It enrolled 600 adults with traumatic brain injury who were admitted to the intensive care unit. The treatment being tested is propranolol 10 mg tablets, given orally, compared with methylcellulose as placebo.
The main thing the trial measures is hospital mortality, meaning how many patients die while in hospital. The study compares in-hospital mortality after 14 days of treatment with propranolol versus placebo. The trial is currently authorised, which means it has received approval to proceed. The record does not report results.
What side effects are known?
The sources provided do not describe side effects of methylcellulose. The product information source lists only the name, form, route and classification of the oral solution, without a side-effect profile.