BACKGROUND:Proton-pump inhibitors effectively suppress stomach acidity. They are widely used for treating gastro-oesophageal reflux disease and related conditions. While generally safe, omeprazole and other proton-pump inhibitors can delay gastric emptying. AIM: To test the hypothesis that tegaserod can normalize or prevent omeprazole-induced delay in gastric emptying. METHODS: This was a randomized, double-blind, placebo-controlled, parallel group study in 40 healthy male volunteers. After informed consent and screening, qualified volunteers were treated with unblinded omeprazole 20 mg b.d. and either blinded tegaserod 6 mg t.d.s. (active treatment group) or placebo-matching tegaserod t.d.s. (control group) for 14 days. Gastric emptying was assessed before and after treatment, using a scintigraphy method. RESULTS:Omeprazole monotherapy significantly delayed gastric emptying expressed by duration of lag-phase (P < 0.007), time to gastric half-emptying (P < 0.003), and gastric retention of the meal at 60 (P < 0.002) and 120 min (P < 0.04) after its ingestion. Tegaserod taken together with omeprazole effectively prevented development of the above effects. Combined treatment was safe and well tolerated. CONCLUSION: Concomitant administration of tegaserod 6 mg t.d.s. prevented development of the delayed gastric emptying induced by omeprazole monotherapy.
RCT Entities:
BACKGROUND: Proton-pump inhibitors effectively suppress stomach acidity. They are widely used for treating gastro-oesophageal reflux disease and related conditions. While generally safe, omeprazole and other proton-pump inhibitors can delay gastric emptying. AIM: To test the hypothesis that tegaserod can normalize or prevent omeprazole-induced delay in gastric emptying. METHODS: This was a randomized, double-blind, placebo-controlled, parallel group study in 40 healthy male volunteers. After informed consent and screening, qualified volunteers were treated with unblinded omeprazole 20 mg b.d. and either blinded tegaserod 6 mg t.d.s. (active treatment group) or placebo-matching tegaserod t.d.s. (control group) for 14 days. Gastric emptying was assessed before and after treatment, using a scintigraphy method. RESULTS:Omeprazole monotherapy significantly delayed gastric emptying expressed by duration of lag-phase (P < 0.007), time to gastric half-emptying (P < 0.003), and gastric retention of the meal at 60 (P < 0.002) and 120 min (P < 0.04) after its ingestion. Tegaserod taken together with omeprazole effectively prevented development of the above effects. Combined treatment was safe and well tolerated. CONCLUSION: Concomitant administration of tegaserod 6 mg t.d.s. prevented development of the delayed gastric emptying induced by omeprazole monotherapy.
Authors: F Inci; M Atmaca; M Ozturk; S Yildiz; R Koceroglu; R Sekeroglu; S H Ipekci; L Kebapcilar Journal: J Endocrinol Invest Date: 2014-01-09 Impact factor: 4.256
Authors: Brian D Furmanski; Shuiying Hu; Ken-Ichi Fujita; Lie Li; Alice A Gibson; Laura J Janke; Richard T Williams; John D Schuetz; Alex Sparreboom; Sharyn D Baker Journal: Clin Cancer Res Date: 2013-06-21 Impact factor: 12.531
Authors: Monika Schöller-Gyüre; Thomas N Kakuda; Goedele De Smedt; Hilde Vanaken; Marie-Paule Bouche; Monika Peeters; Brian Woodfall; Richard M W Hoetelmans Journal: Br J Clin Pharmacol Date: 2008-04-25 Impact factor: 4.335
Authors: Merrill J Egorin; Dhvani D Shah; Susan M Christner; Mara A Yerk; Kristin A Komazec; Leonard R Appleman; Robert L Redner; Brian M Miller; Jan H Beumer Journal: Br J Clin Pharmacol Date: 2009-09 Impact factor: 4.335