A clinical trial to study the safety of Pantoprazole and Levosulpiride for Gastroesophageal reflux disease (GERD)
- Conditions
- Health Condition 1: K210- Gastro-esophageal reflux disease with esophagitis
- Registration Number
- CTRI/2016/03/006730
- Lead Sponsor
- Sun Pharma Laboratories Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 509
Patients must meet all of the following criteria to be considered for enrollment in the study
1.Male or female patients aged between 18 to 65 years.
2.Patients with known history of Gastro esophageal reflux disease (GERD) within last 03 months.
3.Patients who are on Proton pump inhibitor (PPI) alone since 4 weeks prior to screening and not adequately controlled.
Minimum dose/day: Pantoprazole (40 mg), Esomeprazole (20 mg), Omeprazole (20 mg). Rabeprazole (20mg) and Lansoprazole (15 mg).
3. Patients willing to give informed consent.
Patients meeting any of the following criteria must be excluded from enrollment in the study:
1.Pregnant lactating women or women of childbearing age who are not using an acceptable method of birth control.
2.Patients with peptic ulcer or Zollinger Ellison syndrome.
3.Patients with previous surgery of gastrointestinal tract excluding appendectomy, cholecystectomy and polypectomy.
4.Patients with other diseases or conditions such as scleroderma, pancreatitis, cancer, Parkinsonâ??s disease, epilepsy, mania and inflammatory bowel disease.
5.Patients with any severe illnesses (hepatic, renal, cardiac).
6.Patients with uncontrolled diabetes, hypertension, clotting disorder.
7.Heavy smokers (more than 10 cigarettes per day in last 06 months).
8.History of hypersensitivity or known contraindication to either Pantoprazole or Levosulpiride.
9.Recent (in the past two years) drug dependence or abuse.
10.History of non-compliance to medical regimens or those patients unwilling to comply with the study protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ï?§ Observation of Safety profile of patients from baselineTimepoint: 02 and 04 weeks
- Secondary Outcome Measures
Name Time Method ï?§ Change in Frequency Scale for the Symptoms of GERD Scale (FSSG) from baseline <br/ ><br>ï?§ Change in Severity of symptoms of GERD by Likert Scale from baseline <br/ ><br>ï?§ Clinical Global Impression of Improvement (CGI-I) <br/ ><br>ï?§Clinical Global Impression of Severity (CGI-S) <br/ ><br>ï?§Evaluation of neurological side effects by Modified Simpson Angus ScaleTimepoint: [Time frame: 02 and 04 weeks] <br/ ><br>[Time frame: 02 and 04 weeks] <br/ ><br>[Time frame: 02 and 04 weeks] <br/ ><br>[Time frame: Day-0 and 04 weeks] <br/ ><br>[Time frame: Day-0 and 04 weeks]