A clinical trial to study the effects of two drugs, fixed dose combination capsules of Pantoprazole sodium sesquihydrate & Cinitapride hydrogen tartrate ER and Pantoprazole sodium sesquihydrate tablets in patients with non-ulcer dyspepsia (NUD) or gastroesophageal reflux disease (GERD)

Phase 3

Completed

• Conditions: Functional dyspepsia, (2) ICD-10 Condition: K219||Gastro-esophageal reflux disease without esophagitis, Non-ulcer dyspepsia (NUD) or gastroesophageal reflux disease (GERD),

• Registration Number: CTRI/2009/091/000861
• Lead Sponsor: Cadila Healthcare Ltd

Brief Summary

This study is an open label, comparative, multicentric study comparing the safety and efficacy of fixed-dose combination capsules of Pantoprazole & Cinitapride ER and Pantoprazole tablets once daily before meals each for 4 weeks in 200 patients with non-ulcer dyspepsia (NUD) or gastroesophageal reflux disease (GERD) that will be conducted in two centers in India. The primary outcome measures will be the change in the mean intensity score of the symptoms (overall and individual) at the end of the study as compared to the baseline.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-18
• Last Update Posted: 2018-10-27

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• 1.Patients of either sex more than or equal to 18 years of age (No upper age limit was mentioned in our Protocol for this clinical trial).
• 2.Established diagnosis of non-ulcer dyspepsia (NUD) or gastroesophageal reflux disease (GERD) with gastrointestinal symptoms of at least moderate intensity.
• 3.Informed consent of the patient / relative.

Exclusion Criteria

• 1.Pregnancy and/or Lactation.
• 2.Patients with an increased gastrointestinal motility e.g. in patients with gastrointestinal hemorrhage, mechanical obstruction or perforation.
• 3.Patients with ulcerative dyspepsia and/or ulcerative gastritis 4.Patients with severe cardiac, pulmonary, hepatic or renal disease.
• 5.Patients on concomitant medications known to prolong QT interval.
• 6.Patients on concomitant medications known to affect action of Cinitapride like anticholinergic agents such as scopolamine, psychotropic drugs, other dopaminergic agents, or hormones.
• 7.Patients with known hypersensitivity to Pantoprazole or Cinitapride or any other proton pump inhibitors or any other prokinetic agents.
• 9.Patients with continuing history of alcohol and / or drug abuse.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The change in the mean intensity score of the symptoms (overall and individual) at the end of the study (Week 4) as compared to the baseline (prior to initiation of the therapy i.e. Week 0)	1,2,3 & 4 weeks

Secondary Outcome Measures

Name	Time	Method
(1)Improvement in the mean intensity score of the symptoms (overall and individual) as estimated on a weekly basis.	(2)Percentage of patients experiencing complete resolution of symptoms of reduced gastrointestinal motility at the end of the study i.e. 4 weeks.

Trial Locations

Locations (5)

B.Y.L. Nair Hospital & T. N. Medical College, Mumbai; 🇮🇳 Mumbai, MAHARASHTRA, India

Dr. S.N. Medical College, Jodhpur; 🇮🇳 Jodhpur, RAJASTHAN, India

Government Medical College, Vadodara; 🇮🇳 Vadodara, GUJARAT, India

Shashwat Hospital & Research Centre, Ahmedabad; 🇮🇳 Ahmadabad, GUJARAT, India

Smt. N.H.L. Municipal Medical College & Sheth V.S. Hospital, Ahmedabad; 🇮🇳 Ahmadabad, GUJARAT, India

B.Y.L. Nair Hospital & T. N. Medical College, Mumbai

🇮🇳Mumbai, MAHARASHTRA, India

Dr. Girish C. Rajadhyaksha

Principal investigator

girishraj63@hotmail.com