Health Condition 1: K210- Gastro-esophageal reflux disease with esophagitis
Conditions
Interventions
Intervention1: Fixed Dose Combination of Sodium Alginate IP 250mg plus Sodium Bicarbonate IP 133.5mg plus Calcium Carbonate IP 80mg: FDC of sodium alginate plus Sodium bicarbonate plus calcium carbona
Sponsors
ESPI Industries Chemicals Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Male and non-pregnant female Patients diagnosed with symptoms of GERD aged 18 to 65 years (both inclusive). 2 Patients who are in requirement of FDC therapy of Sodium Alginate, Sodium Bicarbonate and Calcium Carbonate as per Investigator discretion. 3 Patients willing to follow the protocol requirements as evidenced by written informed consent. 4 Patients who having sufficient educational level and proficiency in reading and writing in their local language to be capable of reliably completing study questionnaires, as judged by the physician.
Exclusion criteria
Exclusion criteria: 1 Participated in any clinical trial within 30 days prior to the start of the study. 2 Used histamine-2 receptor blockers, over the counter antacids, anticholinergic, cholinergic, spasmolytic, opiates, sucralfate, prokinetics, antibiotics or bismuth compounds within 14 days prior to the start of the study. 3 Any medical condition which might significantly interfere with the functioning of gastrointestinal tract and according to PI which may interfere with the treatment and makes the patients ineligible for participation in study. 4 Patients with highly restricted salt/sodium diet e.g. in some cases of congestive cardiac failure, renal impairment, hypertension, and edema states; patients with known cases of hypercalcemia, nephrocalcinosis, and recurrent calcium containing renal calculi; patients with known or suspected hypersensitivity to the active substance or any of the excipients; or any other conditions or diseases that an investigator considers it as inappropriate to enter the study as per the approved label. 5 Patients taking any medications which might interfere with the action of that FDC of sodium alginate + Sodium bicarbonate + calcium carbonate oral suspension prior to the start of the study 6 Female patients who are pregnant or breast-feeding. 7 Patients who are determined to be the risk group for COVID-19.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The patientsââ?¬â?¢ assessment of upper gastrointestinal disorders-symptom severity index (PAGI-SYM) Heartburn/Regurgitation Subscale from baseline, to Day 28Timepoint: 28 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.The patientsââ?¬â?¢ assessment of upper gastrointestinal disorders-symptom severity index (PAGI-SYM) Heartburn/Regurgitation Subscale from baseline, to Day 14 2.The patientsââ?¬â?¢ assessment of upper gastrointestinal disorders-symptom severity index (PAGI-SYM) Fullness/ Early Satiety, Nausea/Vomiting, Bloating, Upper abdominal pain and Lower abdominal pain Subscale from baseline, to Day 14 and day 28. 3.The patientsââ?¬â?¢ assessment of upper gastrointestinal disorders-Quality of Life (PAGI-QOL) Daily Activities, Clothing, Diet and Food habit, Relationship (REL),Physiological Well- being and Distress Subscale from baseline, to Day 14 and day 28. 4.To evaluate the patientââ?¬â?¢s overall treatment satisfaction on Day 14 and day 28. 5.Monitoring of adverse events and safety assessments, throughout the study period Timepoint: 14 and 28 days | — |
Countries
India
Contacts
Public ContactDr Bhaumik Mody
Ethitrials Contract Research Pvt. Ltd
Outcome results
None listed