A comparison between gastrointestinal blood loss caused by tilcotil (Ro 12-0068) and aspirin in normal volunteers.

An open crossover study was carried out in 6 normal volunteers to measure faecal blood loss caused by tilcotil (Ro 12-0068), a new anti-inflammatory drug, compared with that caused by enteric-coated aspirin. Subjects were allocated at random to receive either single doses of 20 mg tilcotil daily or 900 mg aspirin 4-times daily, reducing to a maximum tolerated dose, over a period of 2 weeks before being crossed over to the alternative medication for a further 2 weeks. Faecal specimens passed during 4 consecutive days in a run-in-period of 1 week, in each treatment period, and in the 2 weeks after the finish of drug therapy were analyzed for blood using a radioactive labelling method. The results showed that faecal blood loss was lower and it did not produce any haematological or biochemical abnormalities or any increase in urinary N-acetyl-beta-glucosaminidase activity indicative of renal damage. It is suggested that the method described provides a simple and reliable means of comparing faecal blood loss with different anti-inflammatory drugs.