Health Condition 1: K21- Gastro-esophageal reflux disease
Conditions
Interventions
Intervention1: Sucralfil® suspension: Sucralfil® suspension administered concomitantly thrice daily prior to a meal with Proton Pump Inhibitor tablet once daily before breakfast and lifestyle measur
Sponsors
Fourrts India Laboratories Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult subjects in the age group 18-65, diagnosed with GERD i.e. Heartburn (defined as a burning sensation in the retrosternal area) with or without regurgitation (defined as the perception of flow of refluxed gastric content into the mouth or hypopharynx) with mild symptoms occurring on two or more days a week or moderate or severe symptoms occurring on one or more days a week 2. Able to understand and complete questionnaires, able to give written informed consent, and have access to a telephone
Exclusion criteria
Exclusion criteria: 1. Patients with alarm symptoms such as unintentional weight loss, progressive difficulty swallowing (dysphagia), iron deficiency anaemia, persistent coughing, laryngitis, pharyngitis and epigastric mass 2. Significant gastrointestinal obstruction, major gastric or oesophageal surgery (excluding appendectomy or cholecystectomy), oesophageal stricture or pyloric stenosis, extra oesophageal manifestations of reflux disease 3. Patients with erosive oesophagitis, Barretts oesophagus (greater than 3cm), Zollinger Ellison Syndrome, scleroderma, malignancy (other than non-melanoma skin cancers) present within the last 5 years, hypersensitivity to rabeprazole or esomeprazole or any PPI, or any other significant condition that, in the opinion of the investigator, could interfere with the patients participation or compliance in the study such as past or current history of alcohol or drug abuse, hepatic, renal, pulmonary, respiratory abnormalities, or who have participated in an investigational drug or investigational device study within 30 days prior to the baseline visit or who are expected to do so during the 4 week study period 4. Female patients who are currently pregnant or breast feeding, or who, in the opinion of the investigator, may become pregnant throughout the study 5. Use of histamine 2 receptor antagonists (H2RAs) within 7 days of randomization, anticholinergics, cholinergics, spasmolytics, opiates, sucralfate, prokinetics, antibiotics (in relation to H. pylori treatment) or bismuth compounds within 14 days of randomization 6. Known Human Immunodeficiency Virus (HIV) positive, Hepatitis B or C status.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparative assessment of efficacy of Concomitant administration of Sucralfate with a Proton Pump Inhibitor versus PPI alone in Gastro Esophageal Reflux Disorder (GERD)Timepoint: Baseline (Visit 1, Day 1) to Study End (Visit 3, Day 28) | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparative assessment of safety of the two arms by monitoring both serious adverse events (SAE) and non-serious solicited and unsolicited adverse events during the study period.Timepoint: Throughout study period | — |
Countries
India
Contacts
Public ContactMr N Balasubramanian
Fourrts (India) Laboratories Pvt Ltd
Outcome results
None listed