Study to Evaluate Efficacy And Safety of Esomeprazole Dual Release Gastro-Resistant Tablets in Comparison to Esomeprazole Tablets in Patients With Refractory Gastroesophageal reflux disease
- Conditions
- Health Condition 1: K219- Gastro-esophageal reflux disease without esophagitis
- Registration Number
- CTRI/2022/03/041014
- Lead Sponsor
- Sun Pharma Laboratories Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 278
1. Patients with refractory GERD [i.e. those who are not fully responding to standard dose of PPIs
once daily (Esomeprazole 40 mg, Lansoprazole 30 mg, Omeprazole 40 mg, Pantoprazole 40 mg or
Rabeprazole 20 mg) administered for at least 8 weeks]
2. Patients who have experienced heartburn symptom on at least 2 of 7 days and regurgitation symptom
on at least 1 of 7 days for at least 8 weeks prior to enrolment.
3. Patient is willing to give informed consent and follow the study protocol.
4. Women of childbearing potential must have a negative urine pregnancy test prior to study entry and agree to use highly effective methods of contraception to prevent pregnancy from study entry till at least two weeks after the last dose of the study medication (such contraception may include
hormonal birth control e.g. combined estrogen and progestogen containing [oral, intravaginal, or
transdermal] or progesterone only [oral, injectable, or implantable] hormonal contraception
associated with inhibition of ovulation, intrauterine devices, intrauterine hormone releasing system OR bilateral tubal occlusion, vasectomized partner, or total sexual abstinence)
[Note: Women with childbearing potential are defined as: those who are not (1) surgically sterile (bilateral oophorectomy, hysterectomy, or bilateral tubal ligation) or (2) post-menopausal. Postmenopausal woman will be defined as: Woman not using hormonal replacement therapy and have
had at least 12 continuous months of natural (spontaneous) amenorrhea and be greater than 45 years of age].
1. Pregnant and/or lactating female.
2. Patients taking any treatment for GERD except PPIs once daily (at prespecified dose) for 8 weeks
before screening or going to take any treatment except study medications and rescue medications
during the study.
3. Current or past history of:
A. Increased GI motility e.g. in patients with GI hemorrhage, mechanical obstruction or perforation
B. Atrophic gastritis or gastric malignancy or other GI malignancy C. Acute peptic ulcer and/or ulcer complications or history of active gastric or duodenal ulcers within 4 weeks prior to screening
D. Patient with Zollinger-Ellision syndrome or other hypersecretory condition
E. GERD complications like Barrettâ??s oesophagus and/or definite dysplastic changes in the
oesophagus
F. Pyloric stenosis, eosinophilic esophagitis, oesophageal stricture, Schatzkis ring, esophageal
varices, hiatus hernia requiring surgical treatment; oesophageal or gastric or duodenal surgery and
planned surgery during the study duration
G. Bleeding disorder or history of hematemesis within last 2 months
H. Clinically significant conditions which included but were not limited to: cardiac, pulmonary,
central nervous system, thyroid, uncontrolled hypertension and diabetes, hepatic or renal disease
4. Patient with â??alarm featuresâ?? in symptomatology, including odynophagia, severe dysphagia, bleeding, weight loss, anemia, and blood in stool, pointing to a possible malignant disease of the GI tract.
5) Patient chronically using ( > 5 doses on demand or for 3 consecutive days) systemic steroids or nonsteroidal anti-inflammatory drugs which included COX-2 inhibitors other than aspirin (<=165 mg is allowed) within last 28 days prior to screening.
6) The patient taking high dose methotrexate, bisphosphonate, strong CYP3A4 or CYP2C19
inhibitors, CYP3A4 or CYP2C19 inducers, agents affecting digestive organs (e.g. M3 receptor
antagonists, Prokinetics, anticholinergic agents, prostaglandins, mucosal protective agents),
anticoagulant therapy or clopidogrel within last 14 days (or 5 half-lives of particular drug,
whichever is longer) or required to take during the study.
7) Surgical or medical condition that, in the judgement of the Investigator or Sponsor, could interfere with absorption, distribution, metabolism, or excretion of the study drugs.
8) Patient with history of HIV and/or HBV and/or HCV.
9) Patients with history of alcohol and/or drug abuse.
10) Participation in another clinical trial in the past 3 months or planning to participate in another clinical trial during the study.
11) Patients having hypersensitivity or any other contraindication to any of the Investigational products or its component.
12) Patients judged unfit for this study by investigator.
13) 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
- Secondary Outcome Measures
Name Time Method