| CTRI Number |
CTRI/2009/091/001053 [Registered on: 23/12/2009] |
| Last Modified On: |
23/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
A clinical Trial in Patients with Symptomatic Gastroesophageal Reflux Disease (GERD). Clinical trial is to study efficacy, safety and tolerability of Ilaprazole 10 mg Tablet in comparison to Omeprazole 20 mg Tablet(reference product). |
Scientific Title of Study
Modification(s)
|
A Comparative, Randomized, Double Blind, Multicentric, Prospective Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Ilaprazole 10 mg Tablet Vs Omeprazole 20 mg Tablet in patients with Symptomatic Gastroesophageal Reflux Disease (GERD). |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| AJ/SC/01/2009 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Shailesh Singh |
| Designation |
Associate Vice President DRA and R&D |
| Affiliation |
Ajanta Pharma Ltd, Advent |
| Address |
Ajanta Pharma Ltd, Advent 43 AB/44CD, Charkop Industrial Estate,Kandivli (West) Mumbai MAHARASHTRA 400 067 India
Ajanta Pharma Ltd, Advent 43 AB/44CD, Charkop Industrial Estate,Kandivli (West) Mumbai MAHARASHTRA 400 067 India
Mumbai
MAHARASHTRA
400 067
India |
| Phone |
022-66062112 |
| Fax |
022-66062100 |
| Email |
shaileshs@ajantapharma.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Shailesh Singh |
| Designation |
Associate Vice President DRA and R&D |
| Affiliation |
Ajanta Pharma Ltd, Advent |
| Address |
Ajanta Pharma Ltd, Advent 43 AB/44CD, Charkop Industrial Estate,Kandivli (West) Mumbai MAHARASHTRA 400 067 India
Ajanta Pharma Ltd, Advent 43 AB/44CD, Charkop Industrial Estate,Kandivli (West) Mumbai MAHARASHTRA 400 067 India
Mumbai
MAHARASHTRA
400 067
India |
| Phone |
022-66062112 |
| Fax |
022-66062100 |
| Email |
shaileshs@ajantapharma.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Shailesh Singh |
| Designation |
Associate Vice President DRA and R&D |
| Affiliation |
Ajanta Pharma Ltd, Advent |
| Address |
Ajanta Pharma Ltd, Advent 43 AB/44CD, Charkop Industrial Estate,Kandivli (West) Mumbai MAHARASHTRA 400 067 India
Ajanta Pharma Ltd, Advent 43 AB/44CD, Charkop Industrial Estate,Kandivli (West) Mumbai MAHARASHTRA 400 067 India
Mumbai
MAHARASHTRA
400 067
India |
| Phone |
022-66062112 |
| Fax |
022-66062100 |
| Email |
shaileshs@ajantapharma.com |
|
Source of Monetary or Material Support
Modification(s)
|
|
Primary Sponsor
Modification(s)
|
| Name |
Ajanta Pharma Ltd |
| Address |
Ajanta Pharma Ltd, Advent 43 AB/44CD, Charkop Industrial Estate,Kandivli (West) Mumbai MAHARASHTRA 400 067 India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mrs S Vithiavathi |
A V M College |
Dept of Medicine,Cuddalore-607402
Pondicherry
PONDICHERRY |
0994557798
drsln@sify.com |
| Dr N Dinkaran |
CSI Kalyani General Hospital |
15, Dr Radhakrishnan Salai,-600 004
Chennai
TAMIL NADU |
09841151599
poornimayadhav@gmail.com |
| Dr L Padma |
Sri Dilip Clinic |
151 (3537) 7th cross Gayathrinagar,Maruthi Extension centre-560 021
Bangalore
KARNATAKA |
0 9448248882
gopinathpadma@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| A V M College, Cuddalore, Pondicherry. |
Approved |
| IEC of Deeksha Hospital, 387/347,Next to post office, B B Road, Nehrunagar,Yelahanka Old towen,Bangalore 560064. |
Approved |
| IEC of Kalyani General Hospital, 15, Radhakrishnan Salai, Chennai 600004. |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K210||Gastro-esophageal reflux disease with esophagitis, Gastroesophageal Reflux Disease , |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Ilaprazole 10 mg Tablet |
once daily for a period of 4 weeks |
| Comparator Agent |
Omeprazole 20 mg Tablet |
once daily for a period of 4 weeks |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Males and non-pregnant females (with negative β-human chorionic gonadotrpin test). Female patients on adequate contraceptive control.
2. Patients with diagnosis of symptomatic GERD, ie. History of atleast 2 episodes of heartburn per week that partially responded to treatment with a proton-pump inhibitor (PPI),
3. H2 receptor antagonist (H2RA) or antacids within the 30 days prior to screening.
4. Patient willing to comply with study procedures and requirements.
|
|
| ExclusionCriteria |
| Details |
1. Pregnant and nursing women.
2. History of previous esophageal or gastric surgery.
3. History of bleeding tendencies, cirrhosis and esophageal varices.
4. History of hypersensitivity or allergy to Omeprazole or Ilaprazole.
5. Patients who would require concomitant therapy with nonsteroidal anti-inflammatory drugs (NSAIDs), salicylates (>165 mg/day), quinidine, warfarin, diazepam, diphenylhydantoins, mephenytoin, H2-receptor antagonists, anticholinergics or prostaglandin analogues.
6. Alcoholics, smokers, tobacco addicts.
7. Immunocompromised states and patients with systemic infections.
8. Patients with severe cardiac, hepatic, renal, or cerebrovascular diseae, malignancy, chronic uncontrolled systemic disease e.g., diabetes, hypertension, asthma, collagen disorders, etc. or any other serious medical illness.
9. Patients who have participated in a new drug study in the past 3 months.
10. Any other condition that in the opinion of the investigator does not justify the patient?s participation in the study.
|
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Pharmacy-controlled Randomization |
Blinding/Masking
Modification(s)
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Heartburn, Acid Regurgitation, Epigastric Pain/ Bloating, Belching |
Day 0, Week 1, Week 2 and Week 4 |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Safety |
Day 0, Week 1, Week 2 and Week 4 |
|
Target Sample Size
Modification(s)
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
15/01/2010 |
| 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
Modification(s)
|
Years="0"
Months="2"
Days="20" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is a Comparative, Randomized, Double Blind, Multicentric, Prospective Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Ilaprazole 10 mg Tablet Vs Omeprazole 20 mg Tablet (Reference Drug), for 4 weeks in 200 patients with Symptomatic Gastroesophageal Reflux Disease. The study will start on 15th January 2010.
Efficacy will be measured by assessing change from baseline to week 1, 2 and 4 symptom and sign scores of heartburn, acid regurgitation, epigastric pain/ bloating, and belching. |