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document
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 . INTRODUCTION 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 .
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Intervention_Pharmacological
nizatidine-controlled release
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Intervention_Pharmacological
nizatidine
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Intervention_Pharmacological
nizatidine controlled release
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Intervention_Pharmacological
nizatidine CR
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Intervention_Pharmacological
single-blind placebo baseline
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Intervention_Pharmacological
double-blind nizatidine CR
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Intervention_Other
Each dose was followed 1 hour later by an
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Intervention_Physical
egg-beater meal
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Intervention_Other
, labeled with Tc99m .
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Intervention_Physical
Gamma camera images were obtained at meal completion , 1- , 2- , 3- and 4-hour postmeal .
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Intervention_Control
placebo
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Intervention_Pharmacological
nizatidine CR
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Intervention_Pharmacological
Nizatidine CR
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Outcome_Physical
acute prokinetic efficacy
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Outcome_Physical
gastric emptying
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Outcome_Physical
delayed gastric emptying
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Outcome_Physical
Gamma camera images
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Outcome_Physical
DGE
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Outcome_Physical
normal gastric emptying
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Outcome_Physical
CFB
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Outcome_Physical
percent gastric retention
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Outcome_Physical
gastric emptying
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Participant_Condition
gastroesophageal reflux disease
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Participant_Condition
gastroesophageal reflux disease ( GERD ) .
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Participant_Sample-size
39
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Participant_Condition
delayed gastric emptying ( DGE )
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Participant_Sample-size
n = 84
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Participant_Sample-size
84
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Participant_Condition
DGE
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Participant_Condition
normal gastric emptying
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Participant_Condition
diabetic
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Participant_Condition
DGE
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Participant_Sample-size
10
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Participant_Condition
GERD
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Participant_Condition
DGE