A Pilot Study to Evaluate Efficacy and Safety of Fixed Dose Combination Capsules in Patients with GERD and Overlapping Symptoms of Dyspepsia
- Conditions
- Health Condition 1: K219- Gastro-esophageal reflux disease without esophagitis
- Registration Number
- CTRI/2020/09/027876
- Lead Sponsor
- Abbott India limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
1. Male and female patients above 18 years of age
2. Patient who has read the informed consent form, has understood the relevant aspects of the clinical study, and grants his/her authorization to participate by signing the informed consent form before the inclusion in the clinical study and the performance of any procedure
3. Patients who have at least a 3-month history of GERD symptoms along with overlapping symptoms of dyspepsia
4. Presence of at least twice a week of heartburn and/or regurgitation and refractory to Pantoprazole 40 mg alone for at least 8 weeks
5. Patients who have discontinued medications that affect esophageal motility or gastric acid secretion 1 week before enrolling into the study. These medications, include but not limiting to prokinetics, PPIs, H2 receptor antagonists, cholinergic and/or anti-cholinergic agents
6. Patients willing to fill patient diaries and comply with the study procedure and requirements
7. Female of childbearing potential must have a negative pregnancy test and be non-lactating at baseline visit
8. Patient willing to use appropriate method of contraception as per investigatorâ??s discretion, throughout the study
1. Patients with Barretts esophagus or esophageal stricture
2. Patients with active or healing gastroduodenal ulcer (except scars)
3. Patients with known cases of gastric, duodenal or esophageal surgery
4. Patients with known cases of malignant disease of any kind
5. Patients with heart failure or and clinically significant renal disease (serum creatinine more than 1.5 mg/dL)
6. Patients with liver disease, low blood pressure, atrophic gastritis, Clostridium difficile related colitis, interstitial nephritis, osteoporosis, vitamin B12 deficiency, low amount of magnesium in blood
7. Patients who have a problem of breathlessness 8. Patients with any other conditions or diseases that investigator considers it as inappropriate to enter the study as per prescribing information
9. Smokers and patients with alcohol abuse
10. Patients with known hypersensitivity to the active substance or any of the excipients
11. Patients participated in any investigational drug trial within 4 weeks before screening
12. Patients who require daily use of non-steroidal anti-inflammatory drugs (NSAIDS), oral steroids, or aspirin
13. Patients taking any medications which might interfere with the action of the study drugs prior to the start of the study
14. Patients who are unlikely to have visits at study sites or comply with study procedures
15. Females who are pregnant/planning to become pregnant/not ready to use contraceptive measures or are lactating
16. Patients who are unsuitable for any other reason to participate in the study in the opinion of the investigator
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The efficacy of FDC of Pantoprazole 40 mg + Itopride 150 mg in terms of reduction in GERD Symptom Assessment Scale (GSAS) distress score from baseline to weeks 2, 4, and 6 in the treatment of GERD patients with overlapping symptoms of dyspepsiaTimepoint: baseline to weeks 2, 4, and 6
- Secondary Outcome Measures
Name Time Method 1. Change in mean domain specific sub score of GSAS distress from baseline to weeks 2, 4, and 6 where a domain specific mean score is calculated by dividing each domain score by the number of items in the domain <br/ ><br>2. Change in mean frequency of GI symptoms in last 7 days on GSAS distress from baseline to weeks 2, 4, and 6 <br/ ><br>3. Mean change in total daily duration (in minutes/hours) of heartburn, regurgitation or dyspepsia over last 7 days from baseline to weeks 2, 4, and 6 <br/ ><br>Timepoint: baseline to weeks 2, 4, and 6