A clinical trial to study the efficacy and safety of fixed dose combination in the treatment of gastroesophageal reflux disease.

Phase 3

Not yet recruiting

• Conditions: GASTROESOPHAGEAL REFLUX DISEASE (GERD)

• Registration Number: CTRI/2012/04/002575
• 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 meal for 4 weeks and comparator drug (proton pumpinhibitor) tablet is once daily in the morning or before breakfast for 4 weeksin 200 patients with Gastro esophageal reflux disease that will be conducted ineight centers in India. The primary outcome measure will be averagechange from baseline to end of study on symptom of heart burn, epigastric painand nausea. The secondary outcome will be average change form baseline to endof study on symptoms of Dysphagia, Chest pain, Dry cough. Evaluation ofClinical global impression on severity (CGI-S) will be done on baseline visitand end of study week 4 (Visit 3). Evaluation of Clinical global impression onimprovement will be done on week 2 (Visit 2) and end of study week 4 (Visit 3).Evaluation of Adverse event/s will be assessed on every visit. This is not a globalstudy.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2012-04-16
• Study Start: 2012-04-19

Recruitment & Eligibility

• Status: Not Yet Recruiting
• 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 Pantoprazole 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.
•Epigastric Pain	Baseline Visit (day 0), week 2 & week 4.
•Nausea	Baseline Visit (day 0), week 2 & week 4.
•Heart burn	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 (8)

Aayush GI care; 🇮🇳 Mumbai, MAHARASHTRA, India

Dr. Bhagat’s Allergy- Asthma Clinic and Respiratory Care Centre; 🇮🇳 Ahmadabad, GUJARAT, India

Dr. Kamdar’s Surgical Clinic; 🇮🇳 Mumbai, MAHARASHTRA, India

Gastrocare clinic; 🇮🇳 Rajkot, GUJARAT, India

Krishna Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

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

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

Vinod Memorial Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Aayush GI care

🇮🇳Mumbai, MAHARASHTRA, India

Dr Prasanna S Shah

Principal investigator

02223673583

drpsshah@yahoo.co.in