| CTRI Number |
CTRI/2025/10/095892 [Registered on: 10/10/2025] Trial Registered Prospectively |
| Last Modified On: |
08/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study of Esomeprazole Dual Release Gastro-Resistant Tablets in Comparison to Esomeprazole Tablets in Patients with acid reflux disease |
|
Scientific Title of Study
|
A Randomized, Active-Controlled, Parallel, Double-Blind, Comparative 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 (GERD) – A pH-Metry/Impedance-Controlled Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SP/GI-Ortho/Esomeprazole/PIV-01-2024 V2.0 dated 04/Apr/2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chintan Khandhedia |
| Designation |
Lead – Clinical Research and RWE |
| Affiliation |
Sun Pharma Laboratories Limited |
| Address |
Sun House, Plot No. 201 B/1,
Western Express Highway, Goregaon (E)
Mumbai
MAHARASHTRA
400063
India |
| Phone |
02243244324 |
| Fax |
|
| Email |
Chintan.Khandhedia@sunpharma.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neeraj Markandeywar |
| Designation |
General Manager - Medical Affairs and Clinical Research |
| Affiliation |
Sun Pharma Laboratories Limited |
| Address |
Sun House, Plot No. 201 B/1,
Western Express Highway, Goregaon (E)
Mumbai
MAHARASHTRA
400063
India |
| Phone |
9022797378 |
| Fax |
|
| Email |
Neeraj.Markandeywar@sunpharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Colette Pinto |
| Designation |
Manager – Clinical Research and RWE |
| Affiliation |
Sun Pharma Laboratories Limited |
| Address |
Sun House, Plot No. 201 B/1,
Western Express Highway, Goregaon (E), Mumbai – 400 063, Maharashtra, INDIA.
Mumbai
MAHARASHTRA
400063
India |
| Phone |
02243244324 |
| Fax |
|
| Email |
Colette.Pinto@sunpharma.com |
|
|
Source of Monetary or Material Support
|
| Sun Pharma Laboratories Limited
Sun House, Plot No. 201 B/1, Western Express Highway,
Goregaon (E), Mumbai 400 063, Maharashtra, India.
|
|
|
Primary Sponsor
|
| Name |
Sun Pharma Laboratories Limited |
| Address |
Sun House, Plot No. 201 B/1, Western Express Highway,
Goregaon (E), Mumbai 400 063, Maharashtra, India.
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rakesh Kalapala |
Asian Institute of Gastroenterology Hospitals |
AIG Hospitals (A Unit of Asian Institute of Gastroenterology)
No 136, Plot No 2/3/4/5, 1st Floor, Department of Gastroenterology, Room No. 7, Survey, 1, Mindspace Rd,
Gachibowli, Hyderabad,
Telangana 500032
Hyderabad
TELANGANA |
9989211034
drrakesh.kalapala@aighospitals.com |
| Dr Akash Shukla |
Seth GS Medical College & KEM Hospital |
Ward 32A, 9th Floor, Department of Gastroenterology, Room No. 32A, M S Building, Seth G. S. Medical College & KEM Hospital. Parel, Mumbai – 400012
Mumbai
MAHARASHTRA |
9869256376
drakashshukla@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Asian Institute of Gastroenterology (IEC- AIG) |
Approved |
| Institutional Ethics Committee-l Seth GS Medical College and KEM Hospital, Mumbai. |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K21||Gastro-esophageal reflux disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Esomeprazole dual release gastro resistant tablet 80 mg |
One tablet of Esomeprazole dual release gastro-resistant tablets 80 mg and one matching placebo tablet of Esomeprazole tablets 40 mg to be taken orally approximately 30 minutes to 1 hour before the first meal of the day; and one matching placebo tablet of Esomeprazole tablets 40 mg to be taken orally approximately 30 minutes to 1 hour before another meal (approximately 12 hours apart). |
| Comparator Agent |
Esomeprazole tablet IP 40 mg |
One tablet of Esomeprazole tablets 40 mg and one matching placebo tablet of Esomeprazole dual release gastro-resistant tablets 80 mg to be taken orally approximately 30 minutes to 1 hour before the first meal of the day and another tablet of Esomeprazole tablets 40 mg to be taken orally approximately 30 minutes to 1 hour before another meal (approximately 12 hours apart). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female GERD patients aged between 18 to 65 years (both inclusive).
2. Patients with Refractory GERD confirmed by:
a. Patients who have experienced moderate to severe heartburn for at least 2 of 7 days despite being on standard dose of PPI (once daily Pantoprazole 40 mg, esomeprazole 40 mg, Rabeprazole 20 mg, Omeprazole 20 mg, Lansoprazole 30 mg) for at least 8 weeks.
i. Moderate heartburn: Discomfort sufficient to cause interference with normal activities
ii. Severe heartburn: Incapacitating, with inability to perform normal activities.
b. Patient with DeMeester score greater than 14.7 as confirmed by endoscopy and combined 24-hour pH Metry/multichannel intraluminal impedance (pH/MII).
3. Patient is willing to give informed consent and follow the study procedure.
4. Female subjects of childbearing potential must be willing to use acceptable methods 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).
|
|
| ExclusionCriteria |
| Details |
1. Pregnancy and/or Lactation
2. Patient chronically using systemic steroids (greater than 5 doses on demand or for 3 consecutive days) or non-steroidal anti-inflammatory drugs including COX-2 inhibitors including aspirin (less than or equal to 165 mg is allowed)
3. Patient taking high dose methotrexate, bisphosphonate, strong Cytochrome P450 (CYP) 3A4 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.
4. Patients taking any treatment for GERD except standard dose of PPIs and antacids for at least 8 weeks before screening or going to take any treatment except study medications and rescue medicines during the study.
5. Presence or history of:
-Increased gastrointestinal motility e.g., in patients with gastrointestinal hemorrhage.
-Mechanical obstruction or perforation.
-Atrophic gastritis or gastrointestinal malignancy or any other malignancy
-Acute peptic ulcer and/or ulcer complications or history of active gastric or duodenal ulcers within 4 weeks before screening.
-Patient with Zollinger-Ellision syndrome or other hypersecretory condition.
-GERD complications like endoscopic Barrett’s esophagus and/or definite dysplastic changes in the esophagus.
-Pyloric stenosis, eosinophilic esophagitis, oesophageal stricture, Schatzkis ring, esophageal varices, hiatus hernia requiring surgical treatment; esophageal or gastric or duodenal surgery and planned surgery during the study duration
-Bleeding disorder or history of hematemesis within the last 8 weeks
7. Surgical or medical condition that, in the judgment of the Investigator or Sponsor, could interfere with the absorption, distribution, metabolism, or excretion of the study drugs.
8. Patient with history of human immunodeficiency virus (HIV) and/or hepatitis B virus (HBV) and/or hepatitis C virus (HCV).
9. Patient with a history of alcohol and/or any form of tobacco/ 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. Patient having hypersensitivity or any other contraindication to the investigational product or its component.
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage of time with intragastric pH greater than 4 during the 24-hour period |
04 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in Esophageal Acid Exposure Time |
04 weeks |
| Median pH in 24 hours |
04 weeks |
| Median pH during nighttime hours (7 pm to 7 am) |
04 weeks |
| Median pH during daytime hours (7 am to 7 pm) |
04 weeks |
| Proportion of patients with normalization of DeMeester score (score less than 14.7) |
04 weeks |
| Change in Total DeMeester score and components of DeMeester score (Upright time in reflux, recumbent time in reflux, total time in reflux, the total number of reflux episodes lasting over 5 minutes, duration of the longest reflux episode, total number of reflux episodes) |
04 weeks |
| Change in total Frequency Scale for Symptoms of GERD (FSSG) score from baseline |
01 week, 04 weeks, 08 weeks, 12 weeks |
| Clinical Global Impression – Improvement scale (CGI-I) rating |
01 week, 04 weeks, 08 weeks, 12 weeks |
| Changes in the quality of life (GERD-HRQL) from baseline |
01 week, 04 weeks, 08 weeks, 12 weeks |
| Proportion of patients with adverse events and serious adverse events |
Throughout the study |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
24/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is an active controlled, parallel, double blind, comparative study to evaluate the efficacy and safety of Esomeprazole Dual Release Gastro - Resistant Tablets 80 mg OD in Comparison to Esomeprazole Tablets 40 mg BID in patients with Refractory Gastroesophageal Reflux Disease (GERD) based on intragastric pH assessment using 24-hour pH Metry/multichannel intraluminal impedance. |