Human tolerability and pharmacodynamic study of Tisacid tablet in duodenal ulcer patients. A prospective, randomized, self-controlled clinicopharmacological study.
A randomized, prospective, crossing-over clinico-pharmacological study was conducted on the tolerability by humans, of TISACID (Al-Mg-hydroxy-carbonate), a new antacid of up-to-date composition produced in Hungary. Even a relatively high dose of the preparation is tolerated by the human organism. During a 6-week continuous treatment neither subjective nor objective side-effects were observed. The tablet is immediately decomposed in the gastric juice, a considerable portion of it will permanently stick to the mucosa of the stomach and duodenum. Depending on the dose, it rapidly and permanently reduces the acidity of the gastric content and increases serum gastrin concentration only moderately and for a short time. Administered together with cimetidine, it promotes healing of duodenal ulcer and the cessation of complaints. It does not increase the aluminium and magnesium concentrations of the plasma not even on prolonged administration, and clinical symptoms and laboratory changes characterizing the phosphate depletion syndrome do not develop either. Based on the results, authors consider Tisacid a beneficial preparation as regards both effectivity and tolerability.
Nagy
L
L
1st Department of Medicine, University Medical School, Pécs, Hungary.
Tárnok
F
F
Past
T
T
Mózsik
G
G
Deák
G
G
Tapsonyi
Z
Z
Fendler
K
K
Jávor
T
T
D000536:Aluminum Hydroxide / Q000009:adverse effects / Q000627:therapeutic use*; D002254:Carbonates / Q000009:adverse effects / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D004381:Duodenal Ulcer / Q000188:drug therapy* / Q000503:physiopathology; D005260:Female; D005750:Gastric Juice / Q000032:analysis; D005755:Gastrins / Q000097:blood; D006801:Humans; D008274:Magnesium / Q000032:analysis / Q000627:therapeutic use*; D008276:Magnesium Hydroxide / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D011446:Prospective Studies; D011897:Random Allocation
D002254:Carbonates; D005755:Gastrins; C043698:almagate; D000536:Aluminum Hydroxide; D008274:Magnesium; D008276:Magnesium Hydroxide