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CTRI Number  CTRI/2008/091/000265 [Registered on: 13/05/2009]
Last Modified On:
Post Graduate Thesis   
Type of Trial   
Type of Study    
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to compare two drugs, R-Sibutramine and Sibutramine, in the management of obesity 
Scientific Title of Study   A comparative clinical trial of R-Sibutramine versus racemate Sibutramine in the management of obesity 
Secondary IDs if Any  
Secondary ID  Identifier 
EPL/R-SIBU/2008/01  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Vaishali Deshmukh 
Designation   
Affiliation   
Address  Muley Arcade, 4th Floor
Tilak Road
Pune
MAHARASHTRA
411030
India 
Phone  02065214388  
Fax    
Email  docvaishali@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Sandeep Sonawane 
Designation   
Affiliation  Manager- Medical Services 
Address  Medical Department, Emcure Pharmaceuticals Ltd
Survey No. 255/2, Phase I, Hinjwadi MIDC
Pune
MAHARASHTRA
411057
India 
Phone  02039821000  
Fax  020-39821019  
Email  Sandeep.Sonawane@emcure.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr. Sandeep Sonawane 
Designation   
Affiliation   
Address  Medical Department, Emcure Pharmaceuticals Ltd
Survey No. 255/2, Phase I, Hinjwadi MIDC
Pune
MAHARASHTRA
411057
India 
Phone  02039821000  
Fax  020-39821019  
Email  Sandeep.Sonawane@emcure.co.in  
 
Source of Monetary or Material Support  
Emcure Pharmaceuticals Ltd., Pune 
 
Primary Sponsor  
Name  Emcure Pharmaceuticals Ltd., Pune 
Address   
Type of Sponsor   
 
Details of Secondary Sponsor  
Name  Address 
Nil   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 11  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shivram Bonagiri  A.J.Medicare, Pune  ,-

 


 
Dr Malhar Dave  Abhishek Hospital  ,-390007
Vadodara
GUJARAT 


 
Dr Gurpreet Dhingra  Dhingra Hospital  ,-
Mumbai
MAHARASHTRA 


 
Dr. Shrihari Dhorepatil   Dr. Shrihari Dhorepatil   B-6, Shardaram Park, 34, Sassoon Road, ,-411001
Pune
MAHARASHTRA 


 
Dr. Vaishali Deshmukh  Dr. Vaishali Deshmukh  Muley Arcade, 4th Floor,Tilak Road-411030
Pune
MAHARASHTRA 


 
Dr. Sujit Chandratreya   Endocare Clinic  Endocare Clinic, Mohiniraj,Gangapur Road-422013

 


 
Dr Pratiksha Das  IPC Heart care  ,-
Mumbai
MAHARASHTRA 


 
Dr Ashwin Porwal  Noble Hospital  ,-

 


 
Dr. Shailaja Kale   Orange Clinic  Dhanvantari Building, Tilak Road,-411030
Pune
MAHARASHTRA 


 
Dr Veena Shinde  Shinde's Clinic  ,-

 


 
Dr Mahesh Padsalge   Shivam Clinic and Research Centre  Off 23, Plot 23, Ambika Shopping Centre,Sector 8, Nerul (W)-400706
Mumbai
MAHARASHTRA 


 
 
Details of Ethics Committee  
No of Ethics Committees= 11  
Name of Committee  Approval Status 
Independent Ethics Committee,A.J.Medicare Pvt Ltd, for Dr Bonagiri  Approved 
Kotbagi Hospital- Independant Ethics Committee for Dr. Ashwin Porwal  Approved 
Kotbagi Hospital- Independant Ethics Committee for Dr. Gurpreet Dhingra  Approved 
Kotbagi Hospital- Independant Ethics Committee for Dr. Mahesh Padsalge  Approved 
Kotbagi Hospital- Independant Ethics Committee for Dr. Malhar Dave  Approved 
Kotbagi Hospital- Independant Ethics Committee for Dr. Pratiksha Das  Approved 
Kotbagi Hospital- Independant Ethics Committee for Dr. Shailaja Kale  Approved 
Kotbagi Hospital- Independant Ethics Committee for Dr. Shrihari Dhorepatil  Approved 
Kotbagi Hospital- Independant Ethics Committee for Dr. Sujit Chandratreya  Approved 
Kotbagi Hospital- Independant Ethics Committee for Dr. Vaishali Deshmukh  Approved 
Kotbagi Hospital- Independant Ethics Committee for Dr. Veena Shinde  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Obesity,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  R-Sibutramine  4.18 mg or 6.28 mg once daily for six months 
Comparator Agent  Sibutramine  8.37 mg or 12.55 mg once daily for six months  
 
Inclusion Criteria  
Age From   
Age To   
Gender   
Details  Subjects with body mass index greater than 27 kg/m2 Subjects of either sex and aged between 18-65 years 
 
ExclusionCriteria 
Details  Known hypersensitivity to Sibutramine Concomitant use of MAO inhibitors, centrally acting appetite suppressants, other centrally acting drugs, drugs that affect hemostasis or platelet function Drug, tobacco or alcohol abuse Psychiatric disorders Endocrine disease other than type II diabetes History of arrhythmias, congestive heart failure, coronary artery disease, stroke, seizures Severe hypertension Pulmonary hypertension Benign prostatic hyperplasia with urinary retention Phaeochromocytoma Hyperthyroidism Untreated hypothyroidism Severe renal or hepatic impairment Narrow angle glaucoma Predisposal to bleeding events Lactating or pregnant women or women of childbearing potential not practicing an effective mode of contraception Organic causes of obesity e.g. Cushing?s syndrome, hypogonadism, congenital disorders, lipodystrophy, lipoatrophy etc. History of major eating disorders Any condition that, in the opinion of the investigator, does not justify the patient?s inclusion in the study  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Decrease in body weight and body mass index Decrease in waist circumference and waist:hip ratio   0,1,2,3,4,5,6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Decrease in appetite Increase in satiety   0,1,2,3,4,5,6 months 
 
Target Sample Size   Total Sample Size="0"
Sample Size from India="" 
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 3 
Date of First Enrollment (India)   Date Missing 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  16/07/2009 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Completed 
Recruitment Status of Trial (India)   
Publication Details    
Brief Summary   This is a double blind, randomized, multi-center, phase III clinical trial conducted to evaluate the efficacy and safety of R-Sibutramine and compare with that of racemate Sibutramine in the management of obesity. A total of 400 patients will be enrolled in the study. All patients will receive either R-Sibutramine (4.19 mg and 6.28 mg capsules) or racemate Sibutramine (8.37 mg and 12.55 mg capsules). For both the treatment groups, the starting dose will be lower strength. The dose may be increased after one month to the higher strength if no response is seen. The patients will also be advised lifestyle modification. All patients will be evaluated every month for efficacy and safety variables during six months therapy. The primary efficacy variable will be percentage of patients having at least 5% weight loss, BMI, waist circumference or waist:hip ratio. The secondary efficacy variables will be improvement in BMI, waist:hip ratio, appetite, satiety, Hamilton depression scale, and lipid profile. The safety variables will be blood pressure, heart rate, ECG, respiratory rate, safety laboratory variables.  
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