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

Phase 3

Active, not recruiting

• Conditions: GASTROESOPHAGEAL REFLUX DISEASE (GERD)

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

Brief Summary

This study is designed to assess the efficacy and safety of dexlansoprazole versus lansoprazole in patients with Gastroesophageal Reflux Disease (GERD). Total 242 patients will be participating in the study from 13 centers throughout xml:namespace prefix = st1 ns = "urn:schemas-microsoft-com:office:smarttags" /India. The study will consist of 7-14 days of screening period and 8 weeks of treatment period. The primary endpoint of the study is to determine mean change in GSAS questionnaire sum scores from baseline to week 2, week 4 and week 8. Adverse events will be recorded during entire study period of the study. xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-04
• Last Update Posted: 2013-08-23

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• 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)	From baseline to 2, 4 and 8 weeks of treatment period.

Secondary Outcome Measures

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

Trial Locations

Locations (13)

Dr. Vijay Sharma Gastroenterology Clinic; 🇮🇳 Jaipur, RAJASTHAN, India

Global Gastro & Liver Centre; 🇮🇳 Jaipur, RAJASTHAN, India

Government Medical College & SSG Hospital; 🇮🇳 Vadodara, GUJARAT, India

Government Medical College and New Civil Hospital; 🇮🇳 Surat, GUJARAT, India

King Edward Memorial Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Kodlikeri Memorial Hospital; 🇮🇳 Aurangabad, MAHARASHTRA, India

Lucknow Gastroenterology & Gynecology Centre; 🇮🇳 Lucknow, UTTAR PRADESH, India

Noble Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Rajajipuram Hospital & Maternity Centre; 🇮🇳 Lucknow, UTTAR PRADESH, India

Satarkar Gastroenterology Centre; 🇮🇳 Aurangabad, MAHARASHTRA, India

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Dr. Vijay Sharma Gastroenterology Clinic

🇮🇳Jaipur, RAJASTHAN, India

Dr Vijay Sharma

Principal investigator

09928015254

vijaysadashiv@gmail.com