| CTRI Number |
CTRI/2010/091/001057 [Registered on: 05/07/2010] |
| Last Modified On: |
27/12/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
Public Title of Study
Modification(s)
|
Lafutidine versus Rabeprazole in the Treatment of Acid Peptic Disease. |
Scientific Title of Study
Modification(s)
|
A parallel, randomized, comparative, double-blind, double-dummy Placebo controlled clinical trial to evaluate the efficacy and safety of Lafutidine versus Rabeprazole in the Treatment of Acid Peptic Disease. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Zuv/Gastr/L-02/2010 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
DR SANJAY KUMAR |
| Designation |
Gastroenterologist |
| Affiliation |
Global Liver Gastrology Centre |
| Address |
E- 5/24, Opp. Aerera petrol pump, Arera Colony
Arera colony,
Bhopal
MADHYA PRADESH
462 016
India |
| Phone |
09893056704 |
| Fax |
|
| Email |
sanjaykrgastro@rediffmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Bhupesh Dewan |
| Designation |
Director- Medical Services |
| Affiliation |
Zuventus Healthcare Ltd. |
| Address |
5119-D Wing, Oberoi Garden Estate, Chandivilli, Andheri (E)
Mumbai
MAHARASHTRA
400 072
India |
| Phone |
022-30610000 |
| Fax |
|
| Email |
medico@zuventus.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Bhupesh Dewan |
| Designation |
Director- Medical Services |
| Affiliation |
Zuventus Healthcare Limited |
| Address |
5119-D Wing, Oberoi Garden Estate, Chandivali, Andheri (E)
Mumbai
MAHARASHTRA
400 072
India |
| Phone |
022-30610000 |
| Fax |
|
| Email |
medico@zuventus.com |
|
|
Source of Monetary or Material Support
|
| ZUVENTUS HEALTHCARE LTD.
5119-D Wing, Oberoi Garden Estate
Chandivilli, Mumbai 400 072
Tel: +91 (0) 22-30610000 / 28472823/24
Fax: +91 (0) 22-28472828/29
|
|
Primary Sponsor
Modification(s)
|
| Name |
Zuventus Healthcare Ltd |
| Address |
.5119 ?D? Wing, Oberoi Garden EstateChandivilli, Mumbai 400 072Tel: +91 (0) 22-30610000 / 28472823/24Fax: +91 (0) 22-28472828/29 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Sanjay Kumar |
Global Liver & Gastroenterology Centre |
E-5/24,Arera Colony-462016
Bhopal
MADHYA PRADESH |
09893056704
sanjaykrgastro@rediffmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jagruti Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K297||Gastritis, unspecified, (2) ICD-10 Condition: K27||Peptic ulcer, site unspecified, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Lafutidine |
One Lafutidine (10 mg) tablet to be taken once daily orally for 28 days in case of gastritis and One Lafutidine (10 mg) tablet to be taken twice daily orally for 28 days in case of peptic ulcer. |
| Comparator Agent |
Rabeprazole |
One Rabeprazole (20 mg) tablet to be taken once daily for 28 days in case of gastritis or peptic ulcer |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female patients aged 18 years or older.
2. Clinical signs and symptoms of Acid peptic disease with endoscopic diagnosis of gastric mucosal injury (erosion/ oozing/redness/edema) as in gastritis (acute or acute exacerbation of chronic gastritis) and/or peptic ulcers (Patients with endoscopically diagnosed A1- or A2-stage ulcer (by Sakita/Miwa classification).
3. Patients willing to give written informed consent and willing to comply with trial protocol.
4. Patients who are on therapy with PPI, H2RAs, NSAIDs, muscarinic antagonists or other gastroprotective agents, but who have undergone a washout period of 7 days wherein only oral antacids are taken.
|
|
| ExclusionCriteria |
| Details |
1. Patients with a known history of hypersensitivity to study medications (rash, fever, itching, etc).
2. Patients who had been treated with drugs capable of interfering with digestive mucosal integrity, gastric secretion or gastrointestinal motility, including H2 receptor antagonists, NSAIDs, muscarinic antagonists, gastroprotective agents (within the previous 7 days).
3. Patients with history of pathological conditions of the intestine including inflammatory bowel disease/malabsorption syndromes/gastrointestinal malignancy/gastric or intestinal surgery including vagotomy/ Barrett's esophagus/ scleroderma.
4. Patients showing alarm features (unintentional weight loss, persistent vomiting, dysphagia, haematemesis, melaena, fever, jaundice, or anaemia), or serious concomitant disease.
5. Patients with signs of significant/massive GI bleeding.
6. Patients who are unsuitable for pharmacotherapy e.g., with GI perforation or pyloric stenosis/esophageal stricture/intestinal obstruction.
7. The presence of major hematological, renal, cardiac, pulmonary, or hepatic abnormalities.
8. Patients who are pregnant, possibly pregnant, lactating, or who desire to become pregnant during the study.
9. Patients who had previously been included or who had participated in any other clinical trial within the last 2 month.
10. Patients who are drug or alcohol abusers or suffering from any other condition associated with poor compliance.
11. Patients who are otherwise judged inappropriate for inclusion in the study by the investigator.
|
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Pre-numbered or coded identical Containers |
Blinding/Masking
Modification(s)
|
Double Blind Double Dummy |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1. Proportion of patients with more than or equal to 50% improvement in baseline symptom severity. 2. Proportion of patients reporting a maximal allowable score of 20 on the VAS Scale for the clinical symptoms evaluated. 3. Proportion of patients reporting a change in the ulcer stage based on the endoscopic examinations. 4. Reduction in the size of the ulcer. 5. Resolution of other endoscopic findings of gastritis and/or peptic ulcers defined as a score of 2 or less for erosions.
|
baseline, day 14 and day 28 |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1. Sustained clinical symptom relief defined as the absence of the clinical symptom evaluated in the previous 7 days. 2. Cure of peptic ulcer based on endoscopic findings.
3. Cure of gastritis and/or peptic ulcers based on the endoscopic examinations. 4. Patient and Investigator assessment of efficacy and tolerance.
|
1. Day 7.
2. Day 28.
3. Day 28.
4. Day 28. |
|
Target Sample Size
Modification(s)
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
Phase of Trial
Modification(s)
|
Phase 4 |
Date of First Enrollment (India)
Modification(s)
|
01/03/2010 |
| Date of Study Completion (India) |
31/10/2010 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Kumar S, Dewan B, Shah D. A Comparative Evaluation of Lafutidine and Rabeprazole in the Treatment of Gastritis and Peptic Ulcer: A Double-blind, Randomized Study in Indian Patients. Journal of Advances in Medicine and Medical Research. 2013 Apr 2:1187-98. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
It is a prospective parallel randomized, double-blind, double-dummy placebo controlled clinical trial. Patients with clinical signs and symptoms of Acid Peptic Disease, confirmed with diagnosis by endoscopy for the presence of gastritis and/or peptic ulcer disease will be enrolled in the study. The study will comprise of two arms: one comprising of patients with gastritis and the other of patients with peptic ulcer. 50 patients will be enrolled in each arm who will receive treatment with either lafutidine or Rabeprazole, as per randomization. A total of 100 patients will be enrolled in the study, where out of 50 patients of first arm, suffering from peptic ulcer, 25 patients shall receive lafutidine and remaining 25 shall receive Rabeprazole. In the second arm, out of 50 Patients suffering from gastritis, 25 shall receive lafutidine and the remaining 25 shall receive Rabeprazole. Patients will be screened prior to enrollment and eligibility will be assessed according to the specified inclusion and exclusion criteria. |