Post marketing surveillance (PMS) Clinical Study of Ranitidine Hydrochloride 150/ 300 mg Tablet (Rantac�® 150/ Rantac�® 300 /Rantac�® OD 300) in patients with GERD (Gastroesophageal Reflux Disease)

Phase 4

Completed

• Conditions: Health Condition 1: K219- Gastro-esophageal reflux disease without esophagitis

• Registration Number: CTRI/2021/10/037668
• Lead Sponsor: JB Chemicals Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-03-07
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 2446

Inclusion Criteria

Subjects meeting all the following conditions will be included:

1.Male or female patients aged between 18 and 70 years (both inclusive).

2.Subjects with the symptoms of GERD having a history of episodes of heartburn for more than or equal to 1 month prior to screening.

3.Patients who heartburn in at least 4 days out of 7 days of the screening period

4.Written, signed and dated informed consent obtained from patients before performing any study related procedures.

5.Patients willing to comply with the protocol requirements.

Exclusion Criteria

Subjects with any of the following conditions will be excluded from the study:

1.Subjects with known hypersensitivity to any of the components of the formulation.

2.Patients chronically using nonsteroidal anti-inflammatory drugs including COX-2 inhibitors (greater than 12 doses per month) other than aspirin

3.Need for continuous anticoagulant therapy

4.Severe unstable or uncontrolled diseases.

5.History of alcohol or drug abuse

6.Patient with Zollinger-Ellision syndrome or other hypersecretory condition

7.Patient with pyloric stenosis, oesophageal stricture, Schatzkis ring, oesophageal or Gastroesophageal surgery and planned surgery during the study duration.

8.A history of or active gastric or duodenal ulcers within 4 weeks prior or had significant acute upper gastrointestinal hemorrhage within 4 weeks of the baseline endoscopy.

9.Pregnancy and lactation:

�Pregnant or lactating or planning to become pregnant during the study period.

�Females who are not ready to use acceptable contraceptive methods during the course of study.

10.Trial related conditions:

�Concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent.

�Currently taking prohibited concomitant medications(s) listed and inability/unwillingness to discontinue them for the entire study period.

�Suspected inability or unwillingness to comply with the study procedures.

Study & Design

• Study Type: PMS
• Study Design: Not specified