Cinitapride Extended-Release Tablets Versus Cinitapride Immediate-Release Tablets in the Treatment of Functional Dyspepsia and Gastroesophageal Reflux Disease : A Randomized Clinical Trial.
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Date
2015-01
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Abstract
Prokinetics are commonly used for
Functional Dyspepsia (FD) and GastroEsophageal Reflux
Disease (GERD). Aims and Objectives: To evaluate the
safety and efficacy of cinitapride Extended-Release (ER)
tablets versus conventional cinitapride Immediate-Release
(IR) tablets for the treatment of FD and GERD. Materials
and Methods: Patients with FD and GERD received either
cinitapride ER 3 mg tablets OD or cinitapride IR 1 mg tablets
TID for 4 weeks in this randomized, multicentre study.
Change in the mean intensity score of gastrointestinal (GI)
symptoms (overall and individual) at the end of the study
and at each weekly follow up visit as compared to baseline,
patients with complete resolution of GI symptoms, patients
with > 50% reduction from baseline in overall intensity
score, rescue medication use and overall efficacy were
recorded. The safety variables were reported adverse events
(AEs), laboratory parameters, electrocardiogram, and
overall tolerability. Unpaired t test, chi square test or Fisher’s
exact test were used for analysis. p < 0.05 was considered
significant. Results: Total 218 patients were enrolled Cinitapride ER tablets were non-inferior (non-inferiority
margin -2.5) to cinitapride IR tablets for the change in the
mean overall GI symptom intensity score at the end of the
study as compared to the baseline (treatment difference -
0.2 (95% CI: -2.2, 1.7)); also, no significant difference
was found for other efficacy variables (p > 0.05). Eight
AEs of mild-to-moderate intensity were reported. There
was also no difference in the overall tolerability between
the study groups (p = 0.875). Conclusions : Both the study
treatments were comparable in terms of safety and efficacy
for the treatment of FD and GERD.
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Keywords
cinitapride extended-release, cinitapride immediate release, functional dyspepsia, gastroesophageal reflux disease
Citation
Rijhwani Puneet, Sawant Prabha, Garg Praveen, Desai Shubha, Daultani Pavankumar, Kshatriya Rakeshkumar, Parmar Mahendra, Mittal Ravindra. Cinitapride Extended-Release Tablets Versus Cinitapride Immediate-Release Tablets in the Treatment of Functional Dyspepsia and Gastroesophageal Reflux Disease : A Randomized Clinical Trial. Indian Medical Gazette. 2015 Jan ; 149 (1): 19-27.