Health Condition 1: K21- Gastro-esophageal reflux disease
Conditions
Interventions
Intervention1: Esomeprazole dual release gastro resistant tablet 80 mg: One tablet of Esomeprazole dual release gastro-resistant tablets 80 mg and one matching placebo tablet of Esomeprazole tablets 4
and one matching placebo tablet of Esomeprazole tablets 40 mg to be taken orally approximately 30 minutes to 1 hour before another meal (approximately 12 hours apart).
Control Intervention1: Esomepraz
Sponsors
Sun Pharma Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female GERD patients aged between 18 to 65 years (both inclusive). 2. Patients with Refractory GERD confirmed by: a. Patients who have experienced moderate to severe heartburn for at least 2 of 7 days despite being on standard dose of PPI (once daily Pantoprazole 40 mg, esomeprazole 40 mg, Rabeprazole 20 mg, Omeprazole 20 mg, Lansoprazole 30 mg) for at least 8 weeks. i. Moderate heartburn: Discomfort sufficient to cause interference with normal activities ii. Severe heartburn: Incapacitating, with inability to perform normal activities. b. Patient with DeMeester score greater than 14.7 as confirmed by endoscopy and combined 24-hour pH Metry/multichannel intraluminal impedance (pH/MII). 3. Patient is willing to give informed consent and follow the study procedure. 4. Female subjects of childbearing potential must be willing to use acceptable methods of contraception (female of childbearing potential is defined as one who has not been postmenopausal for at least one year, or has not been surgically sterilized, or has not had a hysterectomy at least three months prior to the start of this study).
Exclusion criteria
Exclusion criteria: 1. Pregnancy and/or Lactation 2. Patient chronically using systemic steroids (greater than 5 doses on demand or for 3 consecutive days) or non-steroidal anti-inflammatory drugs including COX-2 inhibitors including aspirin (less than or equal to 165 mg is allowed) 3. Patient taking high dose methotrexate, bisphosphonate, strong Cytochrome P450 (CYP) 3A4 or CYP2C19 inhibitors, CYP3A4 or CYP2C19 inducers, agents affecting digestive organs (e.g. M3 receptor antagonists, Prokinetics, anticholinergic agents, prostaglandins, mucosal protective agents), anticoagulant therapy or clopidogrel within last 14 days (or 5 half-lives of particular drug, whichever is longer) or required to take during the study. 4. Patients taking any treatment for GERD except standard dose of PPIs and antacids for at least 8 weeks before screening or going to take any treatment except study medications and rescue medicines during the study. 5. Presence or history of: -Increased gastrointestinal motility e.g., in patients with gastrointestinal hemorrhage. -Mechanical obstruction or perforation. -Atrophic gastritis or gastrointestinal malignancy or any other malignancy -Acute peptic ulcer and/or ulcer complications or history of active gastric or duodenal ulcers within 4 weeks before screening. -Patient with Zollinger-Ellision syndrome or other hypersecretory condition. -GERD complications like endoscopic Barrett s esophagus and/or definite dysplastic changes in the esophagus. -Pyloric stenosis, eosinophilic esophagitis, oesophageal stricture, Schatzkis ring, esophageal varices, hiatus hernia requiring surgical treatment; esophageal or gastric or duodenal surgery and planned surgery during the study duration -Bleeding disorder or history of hematemesis within the last 8 weeks 7. Surgical or medical condition that, in the judgment of the Investigator or Sponsor, could interfere with the absorption, distribution, metabolism, or excretion of the study drugs. 8. Patient with history of human immunodeficiency virus (HIV) and/or hepatitis B virus (HBV) and/or hepatitis C virus (HCV). 9. Patient with a history of alcohol and/or any form of tobacco/ drug abuse. 10. Participation in another clinical trial in the past 3 months or planning to participate in another clinical trial during the study. 11. Patient having hypersensitivity or any other contraindication to the investigational product or its component.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of time with intragastric pH greater than 4 during the 24-hour periodTimepoint: 04 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Esophageal Acid Exposure TimeTimepoint: 04 weeks;Median pH in 24 hoursTimepoint: 04 weeks;Median pH during nighttime hours (7 pm to 7 am)Timepoint: 04 weeks;Median pH during daytime hours (7 am to 7 pm)Timepoint: 04 weeks;Proportion of patients with normalization of DeMeester score (score less than 14.7)Timepoint: 04 weeks;Change in Total DeMeester score and components of DeMeester score (Upright time in reflux, recumbent time in reflux, total time in reflux, the total number of reflux episodes lasting over 5 minutes, duration of the longest reflux episode, total number of reflux episodes)Timepoint: 04 weeks;Change in total Frequency Scale for Symptoms of GERD (FSSG) score from baselineTimepoint: 01 week, 04 weeks, 08 weeks, 12 weeks;Clinical Global Impression Improvement scale (CGI-I) ratingTimepoint: 01 week, 04 weeks, 08 weeks, 12 weeks;Changes in the quality of life (GERD-HRQL) from baselineTimepoint: 01 week, 04 weeks, 08 weeks, 12 weeks;Proportion of patients with adverse events and serious adverse eventsTimepoint: Throughout the study | — |
Countries
India
Contacts
Public ContactMs Colette Pinto
Sun Pharma Laboratories Limited
Outcome results
None listed