Study to determine the efficacy and safety of Dexlansoprazole in Gastroesophageal Reflux patients

Phase 3

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

• Registration Number: CTRI/2012/01/002373
• Lead Sponsor: Cipla Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 242

Inclusion Criteria

Note: There is no upper age limit

Screening Visit 1

1.Written, signed, dated and ethics committee approved informed consent obtained from patients before performing any study related procedures.

2.Patients of both the sexes of age 18 years and above, who can read and write.

3.The patients with the symptoms of GERD having a history of episodes of heartburn for more than or equal to 2 months prior to screening.

Screening Visit 2 and Baseline Visit

1.The patients who experience heartburn on at least 4 of the 7 days of the screening period.

Exclusion Criteria

Screening Visit 1:

1.Patient chronically using non steroidal anti inflammatory drugs including COX-2 inhibitors (greater than 12 doses per month) other than aspirin (less than or equal to 325 mg is allowed) within last 14 days.

2.Need for continuous anticoagulant therapy

3.History of hypersensitivity to study drugs or any of its components

4.Severe unstable or uncontrolled disease

5.History of alcohol or drug abuse or dependence

6.Participation in an investigational study within 30 days prior to screening

7.Female who is pregnant or lactating or planning to become pregnant.

8.Woman of child bearing potential who is unwilling to use adequate methods of contraception.

Screening Visit 2 and Baseline Visit

1.Patient with GERD complications like Endoscopic Barretts oesophagus and/or definite dysplastic changes in the oesophagus

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

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

4.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.

5.Clinically significant laboratory values, as judged by the investigator (as per the assessment on screening visit 2 / Baseline visit)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean Change in GSAS questionnaire sum scores (frequency, severity and distress scale)Timepoint: From baseline to 2, 4 and 8 weeks of treatment period.

Secondary Outcome Measures

Name	Time	Method
Clinically significant changes in laboratory valuesTimepoint: During study period.;Clinically significant changes in vital signs & systemic examinationsTimepoint: During study period.;Incidence and nature of adverse eventsTimepoint: During study period.;Percentage of 24 hours heartburn free daysTimepoint: From baseline to week 2, 4 and 8;Percentage of days without daytime heartburnTimepoint: From baseline to week 2, 4 and 8;Percentage of days without rescue medication useTimepoint: During study period.;Percentage of nights without night time heartburnTimepoint: From baseline to week 2, 4 and 8;Percentage of Patients who achieved sustained resolution of heartburn (7 consecutive heartburn-free days)Timepoint: At week 2, 4 and 8;Percentage of treatment emergent adverse eventsTimepoint: During study period.;Reduction in mean severity of heartburnTimepoint: From baseline to week 2, 4 and 8