| CTRI Number |
CTRI/2013/09/003944 [Registered on: 02/09/2013] Trial Registered Retrospectively |
| Last Modified On: |
26/07/2013 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A comparative study to evaluate the efficacy and safety of Troxipide (100 mg) and Rabeprazole (20 mg) alone and in combination in patients of Acid peptic disorders. |
|
Scientific Title of Study
|
A prospective, comparative, controlled, randomized, open label, parallel, 3-arm study to evaluate and compare the efficacy and safety of Troxipide (100 mg) and Rabeprazole (20 mg) alone and in combination in patients suffering from acid peptic disorders |
| Trial Acronym |
TRO/RAB/11/2011 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sagar Katare |
| Designation |
Junior Resident |
| Affiliation |
Government Medical College, Aurangabad |
| Address |
Department of Pharmacology,
3rd floor, College building,
Government Medical College and Hospital (GHATI),
Panchakki road, Navkheda
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9029015821 |
| Fax |
|
| Email |
drsk85@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kantilal Chandaliya |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College, Aurangabad |
| Address |
Department of Pharmacology,
3rd floor, College building,
Government Medical College and Hospital (GHATI),
Panchakki road, Navkheda
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9423149649 |
| Fax |
|
| Email |
kantilalchandaliya@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sagar Katare |
| Designation |
Junior Resident |
| Affiliation |
Government Medical College, Aurangabad |
| Address |
Department of Pharmacology,
3rd floor, College building,
Government Medical College and Hospital (GHATI),
Panchakki road, Navkheda
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9029015821 |
| Fax |
|
| Email |
drsk85@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College and Hospital,
Panchakki road, Navkheda,
Aurangabad - 431001 |
|
|
Primary Sponsor
|
| Name |
Government Medical College Hospital |
| Address |
Government Medical College and Hospital (GHATI),
Panchakki road, Navkheda,
Aurangabad - 431001 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr Sagar Katare |
GMCH Aurangabad |
Surgical OPD (No. 112)
Government Medical College and Hospital (GHATI),
Panchakki road, Navkheda
Aurangabad
MAHARASHTRA |
9029015821
drsk85@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Government Medical College, Aurangabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Acid Peptic Disorder , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Rabeprazole |
20 mg tablet to be administered once daily per orally for 28 days |
| Intervention |
Troxipide |
100 mg tablet to be administered thrice daily per orally for 28 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
• Patients with symptoms of dyspepsia having Glasgow Dyspepsia Severity Score > 2
OR
• Patients undergoing upper gastro intestinal endoscopy having signs of any of acid peptic disorder
AND
• Subjects who provide a written informed consent
|
|
| ExclusionCriteria |
| Details |
• History of any diagnosed gastrointestinal disorder other than acid peptic disorder
• History of any previous abdominal / gastrointestinal surgery
• History of treatment with drugs capable of interfering with digestive mucosal integrity, acid secretion or gastrointestinal motility, (including H2 receptor antagonists, NSAIDs, muscarinic antagonists, cytoprotective agents) within the previous 7 daysys
• Requires concomitant medication which precludes the evaluation of study medications
• Patients with signs suggestive of any acute complication of acid peptic disorder
• Any contraindication for endoscopy examination
• Evidence of gastric malignancy, pyloric obstruction, or oesophageal stricture on endoscopy
• Patients who are drug or alcohol abusers
• Patients with known hypersensitivity to any of the ingredients of the test / Comparator formulation
• Patients with impairment of renal or hepatic function, severe cardiac disease, any respiratory disease or haematological abnormality
• Pregnant or lactating females
• Simultaneous participation in another clinical study 30 days prior to the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Proportion of patients with improvement of symptoms severity score
• Proportion of patients with improvement on endoscopic evaluation |
• Symptom score: Day 0, Day 14, Day 28
• Endoscopic Evaluation: Day 0, Day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • Symptom severity Sub scores |
Day 0, Day 14, Day 28 |
| • Incidence of Rescue medication use |
Day 28 |
| • Global assessment of efficacy and tolerance by investigator at end of treatment |
Day 0, Day 28 |
| • Adverse event frequency and severity |
As and when it occurs |
| • Laboratory Investigations for safety assessment |
Day 0, Day 28 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
02/07/2012 |
| 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) |
Closed to Recruitment of Participants |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Acid peptic
disorders (APD) is a collective term occuring typically as consequence of either hypersecretion
of acid / pepsin or normal acid effect on diminished mucosal defence or both. APD is one of the most frequent reasons for
medical consultation in Asian countries and has highly prevalence among the
Asian population.
APD though being a heterogeneous pathological condition, commonly
presents will similar cluster of symptoms including Postprandial fullness,
Early satiety, Bloating, Epigastric discomfort (poorly localized), Epigastric
pain (a sharp, easy to pinpoint), Postprandial nausea, Belching after meals, Vomiting
now collectively termed as Dyspepsia. The frequency of medical
visits for dyspepsia has been found to increase with increasing age
and with increasing severity of dyspeptic symptoms. As majority of the patients seek medical care only after the disease-related
symptoms become more frequent or more severe, the current drug
treatment is targeted towards symptomatic relief usually using empirical
acid-suppressive therapy (PPI, H2 blockers, antacids) in primary care.
Proton
pump inhibitors (PPIs) are the most effective class of acid suppression agents providing maximum relief from dyspeptic symptoms.
Rabeprazole
is PPI with a faster onset of action and faster symptom control and also aid
in gastric mucin synthesis.
Since,
APD is end result of an imbalance between mucosal
defensive and aggressive factors a great deal of attention has been focused
on role of the cytoprotective agents in strengthening the mucosal defensive
factors.
Troxipide
is a new gastric cytoprotective agent with antiulcer, anti-inflammatory and
mucus secreting properties. Though the exact mechanism of action of Troxipide is not
fully elucidated, it has been clinically proven to heal gastritis
and gastric ulcers.
Cytoprotection
and Acid suppression being two limbs of the etiopathology of Acid peptic
disorders, drugs acting on both limbs may prove to be a potential synergism in
outcome of the disease. This clinical study is hence been conducted to compare
the relative efficacy of a cytoprotective agent, Troxipide; as monotherapy and
in combination with an acid suppressive agent, Rabeprazole; in alleviating the symptoms of Acid Peptic Disorders against
the currently followed treatment modality
of acid suppression with proton pump inhibitors
|