| CTRI Number |
CTRI/2014/02/004413 [Registered on: 17/02/2014] Trial Registered Retrospectively |
| Last Modified On: |
16/10/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effects of two drugs, Ilaprazole and Rabeprazole in patients with uninvestigated dyspepsia |
|
Scientific Title of Study
|
Effectiveness and Safety of Ilaprazole versus Rabeprazole in patients of uninvestigated dyspepsia: A Randomized controlled study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sourav Das Choudhury |
| Designation |
Junior Resident |
| Affiliation |
Institute of Postgraduate Medical Education & Research |
| Address |
244B A J C Bose Road Department of Pharmacology UCM Building 1st Floor Kolkata 700020
244B A J C Bose Road Department of Pharmacology UCM Building 1st Floor Kolkata 700020
Kolkata
WEST BENGAL
700020
India |
| Phone |
8902708213 |
| Fax |
|
| Email |
varuosdc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Avijit Hazra |
| Designation |
Professor |
| Affiliation |
Institute of Postgraduate Medical Education & Research |
| Address |
244B A J C Bose Road Department of Pharmacology UCM Building 1st Floor Kolkata 700020
Kolkata
WEST BENGAL
700020
India |
| Phone |
9831188172 |
| Fax |
03324764656 |
| Email |
blowfans@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Sourav Das Choudhury |
| Designation |
Junior Resident |
| Affiliation |
Institute of Postgraduate Medical Education & Research |
| Address |
244B A J C Bose Road Department of Pharmacology UCM Building 1st Floor Kolkata 700020
Kolkata
WEST BENGAL
700020
India |
| Phone |
8902708213 |
| Fax |
|
| Email |
varuosdc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Funds are being provided by Department of Pharmacology,Institute of Postgraduate Medical Education Research.
Drug samples are being provided by Lupin. |
|
|
Primary Sponsor
|
| Name |
Institute of Postgraduate Medical Education Research |
| Address |
244B A J C Bose Road Dept of Pharmacology U C M Building Kolkata 700020 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sourav Das Choudhury |
Institute of Postgraduate Medical Education & Research |
244B A J C Bose Road Dept of Pharmacology U C M Building Kolkata 700020
Kolkata
WEST BENGAL |
8902708213
varuosdc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGME&R Research Oversight Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Uninvestigated Dyspepsia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ilaprazole |
a proton pump inhibitor
Dose: 10mg
Route: Oral
Frequency: daily, early morning in empty stomach for a duration of 6 weeks. |
| Comparator Agent |
Rabeprazole |
a proton pump inhibitor
Dose: 20mg
Route: Oral
Frequency: daily, early morning in empty stomach for a duration of 6 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
• Patients, of either sex, aged between 18 - 55 years.
• Symptoms of dyspepsia for at least 1 months
• Moderate-to severe symptoms (score ≥ 4 on the7-point Likert scale for each symptom in global overall symptoms scale).
|
|
| ExclusionCriteria |
| Details |
• Patient with alarm features (unintentional weight loss, persistent vomiting, dysphagia, hemetemesis, melena, fever, jaundice, or anemia),
• History of serious gastrointestinal disease (including peptic ulcers, malignancy, esophageal dysmotility, a previous endoscopic or radiological diagnosis of GERD and Barrett’s esophagus)
• History of irritable bowel syndrome.
• Recent gastrointestinal surgery i.e. within 30 days
• Patients with angina pectoris.
• Patients who show any of the following values at the baseline laboratory tests: Hemoglobin < 9.5 g/dL, total leukocyte count < 3,000/mm3, platelet count < 75,000/mm3, AST and ALT ≥ 100 IU/L, Creatinine ≥ 1.5 mg/dL The blood tests should have been done not more than 4 weeks prior to enrollment.
• Treatment with non-steroidal anti-inflammatory drugs (NSAIDs), H2-blockers, proton pump inhibitors, prokinetic agents, misoprostol or sucralfate 15 days prior to enrollment
• Concomitant use of psychotropic drugs.
• Concomitant serious disease of vital organs such as the liver, kidney, heart or lungs.
• History of hypersensitivity to either of the study drugs or closely allied drugs.
• Women who are pregnant, lactating, or not willing to use adequate methods of contraception.
• History of substance abuse.
• Any other condition which can lead the study investigators to consider the subject unsuitable for selection.
• Patient participating in any other clinical trial or have participated in the last three months.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Global Overall Symptom Scale (7 point Likert scale) |
0 months,3 months, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Modified Frequency Scale for the Symptom of gastroesophageal reflux disease (mFSSGERD)
2. Quality of life (QOL) as measured by SF8 QOL questionnaire
|
1.Modified Frequency Scale for the Symptom of gastroesophageal reflux disease (mFSSGERD)at 0 months,3 months, 6 months
2. Quality of life (QOL) as measured by SF8 QOL questionnaire at 0 months,6 months |
|
|
Target Sample Size
|
Total Sample Size="122"
Sample Size from India="122"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
16/08/2013 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Ilaprazole,
a proton pump inhibitor, has been newly introduced in India, that is being
marketed for the treatment of peptic ulcer disease, gastroesophageal reflux
disease and functional dyspepsia.
There
are no published reports from India of head-to-head comparison between
Ilaprazole and the other proton pump inhibitors, which have known efficacy in
suppressing gastric acid secretion, in the treatment of acid-peptic disorders.
We therefore decided to conduct a double blind , randomized, controlled trial to compare Ilaprazole
with Rabeprazole in uninvestigated dyspepsia.
Study
subjects would be recruited from the General Medicine OPD of Institute of Post
Graduate Medical Education & Research (IPGME&R) and Seth Sukhlal
Karnani Memorial (SSKM) Hospital, Kolkata. Adult subjects (18-55 years) of
either sex, complaining of dyspepsia for at least 1 month would be included.
Subjects with alarm symptoms (indicating risk of gastroesophageal malignancy or
other serious gastrointestinal disorders), those taking drugs that might cause
dyspeptic symptoms and those with serious concomitant disease of vital organs
would be excluded. Subjects would be randomized to receive either Ilaprazole 10
mg once daily or Rabeprazole 20 mg once daily, before breakfast. Drugs would be
administered in double blind manner. Treatment would be for 6weeks and subjects would be
assessed at the end of 3 and 6 weeks. Target sample size, adjusting for
dropouts, is 61 patients per group.
The
primary outcome measure for effectiveness would be total symptom score as
assessed by Global Overall Symptom Scale (each symptom scored on a 7-point
Likert scale). For each symptom, relief would be taken as a score or 3 or less
and resolution as a score of 1 or less. Secondary efficacy variables would be
score on Modified frequency scale for the symptoms of gastroesophageal reflux
disease and Quality of life assessed by SF8 QOL questionnaire. Standard
biochemical test parameters and treatment emergent adverse events would be
recorded as safety variables.
Data
would be analyzed in the Department of Pharmacology, IPGME&R. |