Aliment. Pkarmacol. Tker. (1992) 6, 597-607.
Ranitidine for erosive oesopkagitis : a doubleblind, placebo- confro1led s h d y
W. ROUFAIL", A. BELSITOt, M. ROBINSON*, C. BARISHS, A. RUBINg & GLAXO EROSIVE E S O P H A G I T I S S T U D Y G R O U P * Piedmont Research Associafes, Winston-Salem, NC, t Florida Drug Research, Inc., Bradenton, FL, Oklahoma Foundatiun uf Digestive Research, Oklahoma City, OK, § Wake Research Associafes, Raleigh, NC, g Mefroplex Clinical Research Center, Dallas, TX, U S A
*
Accepted for publication 29 May 1992
SUMMARY
A multicentre, randomized, double-blind, placebo-controlled study was conducted to evaluate the efficacy and safety of ranitidine 150 mg and 300 mg in 342 patients with erosive oesophagitis. Treatment was given four times daily, and continued for 12 weeks or until healing (that is, normal or only erythematous mucosa). Erosive oesophagitis healing rates, as determined by endoscopy, were significantly greater in ranitidinetreated patients by 4 weeks compared with those of placebo-treated patients. By 12 weeks, erosive oesophagitis healing rates were 83 and 81% for ranitidine-treated patients (150 and 300 mg, respectively) and 58% for placebo-treated patients ( P 0.001, ranitidine DS. placebo). Symptomatic relief was achieved within 24 hours after starting either dosage of ranitidine. Heartburn frequency ( P < 0.001) and severity (P < 0.001), as well as antacid consumed per week (P < 0.001), were reduced in both ranitidine groups in comparison with placebo. Healing rates and symptom relief were similar in the two ranitidine groups. Both
Ranitidine for erosive oesopkagitis : a doubleblind, placebo- confro1led s h d y
W. ROUFAIL", A. BELSITOt, M. ROBINSON*, C. BARISHS, A. RUBINg & GLAXO EROSIVE E S O P H A G I T I S S T U D Y G R O U P * Piedmont Research Associafes, Winston-Salem, NC, t Florida Drug Research, Inc., Bradenton, FL, Oklahoma Foundatiun uf Digestive Research, Oklahoma City, OK, § Wake Research Associafes, Raleigh, NC, g Mefroplex Clinical Research Center, Dallas, TX, U S A
*
Accepted for publication 29 May 1992
SUMMARY
A multicentre, randomized, double-blind, placebo-controlled study was conducted to evaluate the efficacy and safety of ranitidine 150 mg and 300 mg in 342 patients with erosive oesophagitis. Treatment was given four times daily, and continued for 12 weeks or until healing (that is, normal or only erythematous mucosa). Erosive oesophagitis healing rates, as determined by endoscopy, were significantly greater in ranitidinetreated patients by 4 weeks compared with those of placebo-treated patients. By 12 weeks, erosive oesophagitis healing rates were 83 and 81% for ranitidine-treated patients (150 and 300 mg, respectively) and 58% for placebo-treated patients ( P 0.001, ranitidine DS. placebo). Symptomatic relief was achieved within 24 hours after starting either dosage of ranitidine. Heartburn frequency ( P < 0.001) and severity (P < 0.001), as well as antacid consumed per week (P < 0.001), were reduced in both ranitidine groups in comparison with placebo. Healing rates and symptom relief were similar in the two ranitidine groups. Both
