A clinical trial to study the effects of two drugs Pantoprazole Dual-release Gastro-resistant tablet and Pantoprazole tablet in patients having Gastro Esophageal Reflux Disease in India.
- Conditions
- Health Condition 1: K210- Gastro-esophageal reflux disease with esophagitis
- Registration Number
- CTRI/2017/08/009485
- Lead Sponsor
- Sun Pharma Laboratories Limited SP
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 300
1. Male or female patients with the age between 18 to 65 years (both inclusive)
2. Patients with refractory moderate to severe heart burn symptoms of GERD (i.e. those who have failed on conventional treatment and confirmed by endoscopy and pH metry):
-Moderate: discomfort sufficient to cause interference with normal activities
-Severe: incapacitating, with inability to perform normal activities
-Conventional treatment: Pantoprazole 40 mg tablet once daily for at least 8 weeks
3. Patients who have experienced moderate to severe heartburn on at least 1 of 7 days prior to enrolment
4. Patient is willing to give informed consent and follow the study protocol
5. Female subjects of childbearing potential must be willing to use acceptable method of contraception (female of childbearing potential is defined as one who has not been postmenopausal for at least one year, or has not been surgically sterilized, or has not had a hysterectomy at least three months prior to the start of this study.Acceptable method of contraception includes (e.g. barrier method with spermicide). The calendar method, withdrawal, or an IUD is NOT and acceptable method
1. Pregnant and/or Lactation
2. Patient chronically ( > 5 doses on demand or for 3 consecutive days) using systemic steroids or non steroidal anti inflammatory drugs including COX-2 inhibitors other than aspirin (less than or equal to 325 mg is allowed) within last 28 days prior to screening. Need for continuous anticoagulant therapy.
3. Patients taking any treatment for GERD except pantoprazole 40 mg once daily for 8 weeks before screening or going to take any treatment except study medications and rescue medicines during the study
4. Current or past history of:
-Increased gastrointestinal motility e.g. in patients with gastrointestinal hemorrhage, Mechanical obstruction or perforation
-Atrophic gastritis or gastric malignancy or other GI malignancy
-Acute peptic ulcer and/or ulcer complications or history of active gastric or duodenal Ulcers within 4 weeks prior screening
-Patients with Zollinger-Ellision syndrome or other hypersecretory condition
-GERD complications like Endoscopic Barretts oesophagus and/or definite dysplastic changes in the oesophagus
-Pyloric stenosis, oesophageal stricture, Schatzkis ring, oesophageal or Gastroesophageal surgery and planned surgery during the study duration.
-Bleeding disorder or History of hemastemesis within last 2 months
-Clinically significant conditions including but not limited to: cardiac, pulmonary, central nervous system, thyroid, uncontrolled hypertension and diabetes, hepatic or renal disease
5. Surgical or medical condition that, in the judgment of the Investigator or Sponsor, could interfere with absorption, distribution, metabolism, or excretion of the study drugs
6. Patients with history of alcohol and /or drug abuse
7. Participation in another clinical trial in the past 3 months
8. Patients having hypersensitivity or any other contraindication to any of the Investigational products or its component
9. Patients judged unfit for this study by investigator
10. Investigator, study personnel, sponsor representatives and their first degree relatives
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Change in total FSSG score from baseline <br/ ><br>2.Percentage of 24 hours (with neither daytime nor night time) heartburn free daysTimepoint: 1.Time frame: 04 weeks <br/ ><br>2.Time frame: 04 weeks
- Secondary Outcome Measures
Name Time Method 1.% of 24 hours(with neither daytime nor night time)heartburn free days <br/ ><br>2.% of days without night time heartburn <br/ ><br>3.% of days without daytime heartburn <br/ ><br>4.% of Patients who achieved sustained resolution of heartburn(7 consecutive heartburn-free days) <br/ ><br>5.No. of times rescue medicines taken <br/ ><br>6.Change in the CGI-I from baseline <br/ ><br>7.Changes in the quality of life(GERD-HRQL)from baseline <br/ ><br>Safety: Proportion of participants with adverse events and serious adverse eventsTimepoint: 1.Time frame: 02 weeks <br/ ><br>2.Time frame: 02, 04 weeks <br/ ><br>3.Time frame: 02, 04 weeks <br/ ><br>4.Time frame: 02, 04 weeks <br/ ><br>5.Time frame: 02.04 weeks <br/ ><br>6.Time frame: 02, 04 weeks <br/ ><br>7.Time frame: 02,04 weeks <br/ ><br>Safety:Time frame: 04 weeks