Multicenter, double-blind, placebo-controlled crossover study to assess the acute prokinetic efficacy of nizatidine-controlled release (150 and 300 mg) in patients with gastroesophageal reflux disease.
BACKGROUND
The aim of the study is to test whether nizatidine delivered via a unique bimodal pulsatile-controlled release system, nizatidine controlled release (CR), accelerates gastric emptying in patients with gastroesophageal reflux disease (GERD).


METHODS
Combined data were analyzed on 39 patients with delayed gastric emptying (DGE) from 2 studies (n = 84) assessing the prokinetic effect of nizatidine CR. A single-blind placebo baseline was followed by double-blind nizatidine CR (150 and 300 mg) in randomized sequence, 2 to 5 days apart. Each dose was followed 1 hour later by an egg-beater meal, labeled with Tc99m. Gamma camera images were obtained at meal completion, 1-, 2-, 3- and 4-hour postmeal. All the 84 patients were classified at baseline with DGE (gastric retention >6.3% at 4 hours) or normal gastric emptying.


RESULTS
In the 39 patients identified with DGE, change from placebo baseline (CFB) for percent gastric retention at 4-hour postmeal with nizatidine CR (150 and 300 mg) was each improved and statistically significant (P < 0.05). In a subgroup of diabetic patients with DGE (n = 10), the CFB with nizatidine CR (300 mg) was significant (P < 0.05) at 3- and 4-hour postmeal.


CONCLUSIONS
Nizatidine CR (150 and 300 mg) significantly enhanced gastric emptying of a standard meal in patients with GERD with DGE.
McCallum
Richard W
RW
Kansas University Medical Center, Kansas City, KS, USA.
Zarling
Edwin J
EJ
Goetsch
Allen C
AC
Griffin
Carl
C
Sarosiek
Irene
I
Hejazi
Reza A
RA
Doyle
Ralph T
RT
Rotenberg
Keith
K
D018592:Cross-Over Studies; D003692:Delayed-Action Preparations; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005746:Gastric Emptying / Q000187:drug effects; D005764:Gastroesophageal Reflux / Q000000981:diagnostic imaging / Q000188:drug therapy*; D006635:Histamine H2 Antagonists / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D016567:Nizatidine / Q000008:administration & dosage*; D011877:Radionuclide Imaging; D013667:Technetium
D003692:Delayed-Action Preparations; D006635:Histamine H2 Antagonists; D013667:Technetium; D016567:Nizatidine