mobiflex and Gastrointestinal-Hemorrhage

Faecal blood loss arising from tenoxicam at a dose of 20 mg/day was compared to that arising from piroxicam at a dose of 20 mg/day in a double-blind, parallel comparative study in 12 healthy male volunteers. Faecal blood loss was measured for a 1-week run-in on placebo, during 4 weeks of treatment and for a 2-week post-treatment period in both groups. Plasma levels for tenoxicam and piroxicam confirmed good compliance in all subjects. Mean blood loss during the placebo run-in period was 0.35 ml/day. Mean blood loss during treatment with tenoxicam was 0.84 ml/day and with piroxicam 0.81 ml/day. There was no significant difference between these measurements. On cessation of treatment, faecal blood loss continued both in the tenoxicam group (mean 1.30 ml/day) and piroxicam group (mean 1.41 ml/day). The difference between these was not statistically significant. No significant haematological or biochemical abnormality resulted from either of the two trial drugs during the period of the study. Urinalysis and NAG/creatinine ratio also remained unaltered in both treatment groups.

Topics: Adult; Anti-Inflammatory Agents, Non-Steroidal; Chromatography, High Pressure Liquid; Double-Blind Method; Gastrointestinal Hemorrhage; Humans; Male; Middle Aged; Occult Blood; Piroxicam; Thiazines

An open crossover study was carried out in 8 normal volunteer subjects to compare faecal blood loss resulting from tilcotil (Ro12-0068), a new anti-inflammatory agent, and from enteric-coated aspirin. After a 1-week run-in period, subjects were allocated at random to receive treatment for 2 weeks with either 40 mg tilcotil as a single dose per day or aspirin, 900 mg 4-times daily, reduced if necessary to a maximum tolerated dose. Subjects were then crossed over to the alternative treatment for a further 2 weeks. The results showed that tilcotil produced less blood loss, assessed by a radioactive labelling method, and was better tolerated than aspirin. Plasma concentrations of tilcotil showed that the drug's half-life was approximately 50 hours, compatible with once daily dosage, and steady state concentrations on multiple dosing were reached after 10 to 12 days.

Topics: Adult; Anti-Inflammatory Agents, Non-Steroidal; Aspirin; Clinical Trials as Topic; Dose-Response Relationship, Drug; Female; Gastrointestinal Hemorrhage; Humans; Kinetics; Male; Middle Aged; Piroxicam; Random Allocation; Thiazines

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.

Topics: Acetylglucosaminidase; Adult; Anti-Inflammatory Agents; Aspirin; Female; Gastrointestinal Hemorrhage; Humans; Kidney; Male; Middle Aged; Piroxicam; Thiazines

Topics: Anti-Inflammatory Agents, Non-Steroidal; Child; Female; Gastrointestinal Hemorrhage; Humans; Piroxicam; Stomach Diseases