A clinical trial to study the efficacy and safety of fixed dose combination of a proton pump inhibitor and a dopamine antagonist in the treatment of gastroesophageal reflux disease.

Phase 3

Completed

• Conditions: GASTROESOPHAGEAL REFLUX DISEASE (GERD)

• Registration Number: CTRI/2012/03/002508
• Lead Sponsor: Sun Pharmaceutical Industries Ltd

Brief Summary

Thisstudy is a randomized, open label, parallel group, multi-centre study comparingthe safety and efficacy of Fixed dose combination of a proton pump inhibitor anda prokinetic drug versus same proton pump inhibitor in GERD. Dosing schedule of fixed dose combination capsuleis once daily before breakfast for 4 weeks and comparator drug (proton pumpinhibitor) tablet is once daily before breakfast for 4 weeks in 200 patientswith Gastro esophageal reflux disease that will be conducted in nine centers inIndia. The primary outcome measure will be average change from baseline to endof study on symptom of heart burn, epigastric pain and nausea. The secondaryoutcome will be average change form baseline to end of study on symptoms ofDysphagia, Chest pain, Dry cough. Evaluation of Clinical global impression onseverity (CGI-S) will be done on baseline visit and end of study. Evaluation ofClinical global impression on improvement will be done on week 2 (Visit 2) andend of study. Evaluation of Adverse event/s will be assessed on every visit. This is not a globalstudy.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-21
• Last Update Posted: 2012-09-13

Recruitment & Eligibility

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

Inclusion Criteria

• 1.Male or female patients aged between 18-70 years.
• 2.Patients with GERD (Gastro esophageal Reflux Disease).
• 3.Patients willing to give informed consent.

Exclusion Criteria

• 1.Pregnant, lactating women or women of childbearing age who are not using an acceptable method of birth control.
• 2.Patients with peptic ulcer or Zollinger-Ellison syndrome.
• 3.Patients with previous surgery of gastrointestinal tract excluding appendectomy, cholecystectomy and polypectomy.
• 4.Patients with other diseases or conditions such as scleroderma, pancreatitis, cancer, Parkinson’s disease, epilepsy, mania and inflammatory bowel disease.
• 5.Patients with any severe illnesses (hepatic, renal, cardiac).
• 6.Patients with uncontrolled diabetes, hypertension, clotting disorder.
• 7.History of heavy smoking (> 20 cigarettes per day).
• 8.Hypersensitive to either esomeprazole or levosulpiride.
• 9.Recent (in the past two years) drug dependence or abuse.
• 10.History of non-compliance to medical regimens or those patients unwilling to comply with the study protocol.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Average change from baseline to end of study of following symptoms by Likert scale:	Baseline Visit (day 0), week 2 & week 4.
•Heart burn	Baseline Visit (day 0), week 2 & week 4.
•Epigastric Pain	Baseline Visit (day 0), week 2 & week 4.
•Nausea	Baseline Visit (day 0), week 2 & week 4.

Secondary Outcome Measures

Name	Time	Method
1.Average change from baseline to end of study of following symptoms evaluated by ‘Present (0)’ or ‘Absent (1)’:	•Dysphagia

Trial Locations

Locations (7)

Dr Prashant Mahajan’s Clinic; 🇮🇳 Pune, MAHARASHTRA, India

Heart and Diabetes Care Centre; 🇮🇳 Mumbai, MAHARASHTRA, India

Medilink Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Pai Clinic and Diagnostic Centre; 🇮🇳 Pune, MAHARASHTRA, India

PRATIBHA Digestive Disease & Endoscopy Centre; 🇮🇳 Sangli, MAHARASHTRA, India

Sai krupa Hospital and Endoscopy Centre; 🇮🇳 Kolhapur, MAHARASHTRA, India

Shree Clinic; 🇮🇳 Nashik, MAHARASHTRA, India

Dr Prashant Mahajan’s Clinic

🇮🇳Pune, MAHARASHTRA, India

Dr Prashant Mahajan

Principal investigator

9881504812

drmahajanp@yahoo.co.in