Health Condition 1: K219- Gastro-esophageal reflux disease without esophagitis
Conditions
Interventions
Intervention1: Nil: Nil
Control Intervention1: Nil: Nil
Control Intervention2: Omeprazole 40mg or Esomeprazole 80mg: As directed by the treating physician for 8 Plus and minus 1 weeks
Sponsors
Dr Reddys Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female greater than equal to 18 years 2. Patients diagnosed with severe erosive GERD by treating physician 3. Patients who were on regular dose of PPI (Rabeprazole 20mg, Pantoprazole 40mg, Omeprazole 20mg/Esomeprazole 40mg) as initial therapy for the last 4 - 8 weeks and with incomplete symptomatic relief OR Patients who will be commenced on high dose of PPI (Rabeprazole 40mg, Pantoprazole 80mg, Omeprazole 40mg/Esomeprazole 80mg) as initial therapy 4. Willingness to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Patients with complications associated with GERD (esophageal stricture, Barretts esophagus, esophagitis and asthma) organic causes 2. Patients with known history of surgical management of GERD 3. Patients with known history of high-dose PPI usage 4. Refusal or inability to comply with the requirements of the protocol for any reason, including answering questionnaires 5. Any other condition(s) that would make the patient, in the opinion of the Investigator, unsuitable for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Proportion of subjects with severe erosive GERD based on severity of diurnal symptoms heartburn, regurgitation, epigastric distress, and dysphagia graded as follows at baseline, 4 week, and 8 week- Absent, score 0 Mild, score 1, awareness of symptom, but easily tolerated Moderate score 2, discomfort sufficient enough to cause interference with normal activities, including sleep Severe, score 3, incapacitating, with inability to perform normal activities, including sleep Timepoint: 4 week, and 8 week | — |
Secondary
| Measure | Time frame |
|---|---|
| Primary Outcome Continued 3. Proportion of subjects with severe erosive GERD showing improvement in the severity of diurnal symptoms heartburn, regurgitation, epigastric distress, & dysphagia, graded as above, at 4 plus & minus 1 weeks & 8 plus & minus 1 weeks 4. Proportion of subjects with severe erosive GERD showing improvement in severity of nocturnal symptoms heartburn, regurgitation, epigastric distress, & dysphagia, graded as above, at 4 plus & minus 1 weeks & 8 plus & minus 1 weeks 5. Change in mean total QOLRAD-RI score from baseline to 4 plus & minus 1 weeks & 8 plus & minus 1 weeks 6. Change in QOLRAD-RI mean domain scores from baseline to 4 plus & minus 1 weeks & 8 plus & minus 1 weeks Timepoint: 4 plus & minus 1 weeks, & 8 plus & minus 1 weeks;Secondary Outcome 1. Demographic profile of enrolled subjects with severe erosive GERD 2. Clinical presentation of severe erosive GERD in enrolled subjects 3. Proportion of subjects with severe erosive GERD experiencing adverse events AEs from baseline to 4 plus & minus 1 weeks & 8 plus & minus 1 weeks 4. Patient satisfaction at 4 plus & minus 1 weeks & 8 plus & minus 1 weeks, graded on a 5-point Likert scale Strongly satisfied=5, Satisfied=4, Not sure=3, Dissatisfied=2, Strongly dissatisfied=1 5. Treatment compliance at 4 plus & minus 1 weeks & 8 plus & minus 1 weeks, graded on a 5- point scale Never = 5, Rarely = 4, Sometimes = 3, Often = 2, Very often = 1Timepoint: 4 plus & minus 1 weeks, & 8 plus & minus 1 weeks;Exploratory Endpoint: Change in endoscopic findings from baseline to 4 plus & minus 1 weeks & 8 plus & minus 1 weeks based on available dataTimepoint: 4 plus & minus 1 weeks, & 8 plus & minus 1 weeks;Primary outcome continued 2. Proportion of subjects with severe erosive GERD based on severity of nocturnal symptoms heartburn, regurgitation, epigastric distress, & dysphagia graded as above at baseline, 4 plus & minus 1 week, & 8 plus & minus 1 weekTimepoint: 4 plus & minus 1 weeks, & 8 p | — |
Countries
India
Contacts
Public ContactDr Monjori Mitra
Dr Reddys Laboratories Limited
Outcome results
None listed