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

Evaluation of efficacy and safety of fixed dose combination of a proton pump inhibitor in the treatment of gastroesophageal reflux disease (GERD): a randomized, open label, comparative, multicentric study.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/04/002575

Enrollment

200

Registered

2012-04-16

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- GASTROESOPHAGEAL REFLUX DISEASE (GERD)

Interventions

Intervention1: IP-026 (FDC of Pantoprazole (40 mg) and Levosulpiride SR (75 mg)) capsule: The recommended dose is 1 capsule once daily before meals orally for 4 weeks. Control Intervention1: BY-1023 (

Eligibility

Inclusion criteria

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

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, Parkinsonâ??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.

Design outcomes

Primary

Measure	Time frame
Average change from baseline to end of study of following symptoms by Likert scale: â?¢ Heart burn â?¢ Epigastric Pain â?¢ Nausea Timepoint: Baseline Visit (day 0), week 2 & week 4.	—

Secondary

Measure	Time frame
1.Average change from baseline to end of study of following symptoms evaluated by â??Present (0)â?? or â??Absent (1)â??: â?¢Dysphagia â?¢Chest pain â?¢Dry cough 2.Evaluation CGI-S and CGI-I Timepoint: 1.Baseline Visit (day 0), week 2 & week 4. 2.For CGI-S, at Baseline visit (day 0) and week 4 only and for CGI-I, at week 2 & week 4 only.	—

Countries

India

Contacts

Public ContactDr Surendra Borgharkar

Sun Pharmaceutical Industries Ltd.

medical.services@sunpharma.com02266969696

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026