a study to assess effectiveness amd safety of combination of two medicine will be used for treatment of gastroesophageal reflux disease.

A Multicentric, Randomized, Open Label, Parallel-group, Comparative Clinical trial to evaluate the Safety and Efficacy of the Fixed-dose combination of Esomeprazole Magnesium 40 mg DR and Levosulpiride ER 75 mg Capsule versus Esomeprazole Magnesium 40 mg DR tablet in patients with Gastroesophageal Reflux Disease

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/02/002406

Enrollment

200

Registered

2012-02-07

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- With Gastroesophageal reflux disease

Interventions

Intervention1: Fixed-dose combination of Esomeprazole Magnesium 40 mg DR and Levosulpiride ER 75 mg capsule: Will be givenorally once daily for 6 week Control Intervention1: Esomeprazole Magnesium 40

Eligibility

Inclusion criteria

Inclusion criteria: ?Newly diagnosed GERD patients having non-erosive or erosive GERD with heartburn and acid regurgitation as the predominant symptoms and episode of heart burn and acid regurgitation occurring on at least 2 days during the last 7 days prior to inclusion. ?Adult males or females, age 18 years. ?All subjects who are willing to give informed consent. ?All subjects who are willing adhere to protocol requirements.

Exclusion criteria

Exclusion criteria: ?History or presence of upper gastrointestinal anatomic or motor disorders. ?Acute peptic ulcer and/or ulcer complications. ?Bleeding disorder or History of hematemesis within last 2 months. ?Barret?s esophagus or dysplastic changes in esophagus ?Intake of Glucocortocoids or NSAIDS for more than three consecutive day/week during last month. ?Intake of PPI, H2 blocker or prokinetic for more than 3 consecutive days in previous 7 days. ?History of atrophic gastritis or gastric malignancy or other GI malignancy. ?Any major cardiovascular, pulmonary, hematologic, hepatic, renal, metabolic, gastrointestinal or endocrine disorder. ?Any major surgery in previous 1 month. ?History of Pheochromocytoma, epilepsy, mania, breast diseases ?History of drug or medication abuse within the past year, or current alcohol abuse. ?Previous participation in any esomeprazole magnesium or levosulpiride clinical trial within last 1 month. ?Hypersensitivity to PPI or levosulpiride ?Subjects with serum ALT, AST, of 2.5 X ULN and S.Bilirubin 1.5 X ULN ?Subject with serum creatinine ULN ?Women with positive urine pregnancy test. ?Women who are breast feeding and females of childbearing potential who are not using acceptable contraceptive methods

Design outcomes

Primary

Measure	Time frame
1) Change in the severity of GERD symptoms at the end of 3rd and 6th week of treatment. 2) Change in the frequency of GERD symptoms at the end of 3rd and 6th week of treatment. Timepoint: 1) Change in the severity of GERD symptoms at the end of 3rd and 6th week of treatment. 2) Change in the frequency of GERD symptoms at the end of 3rd and 6th week of treatment.	—

Secondary

Measure	Time frame
) Change in the endoscopic finding (Grade A, B, C, D) according to Los Angeles classification in patient with Erosive GERD at the end of 6 weeks of treatment.Timepoint: At the end of 6 week	—

Countries

India

Contacts

Public ContactDr Vipul prajapati

Torrent Research Centre

ambrishsrivastava@torrentpharma.com7923969100-181

Outcome results

None listed

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