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CTRI Number  CTRI/2009/091/000336 [Registered on: 14/09/2009]
Last Modified On: 27/05/2013
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study
Modification(s)  
Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study
Modification(s)  
A clinical trial to study the effective dose range of the study drug, Sativex, in patients with advanced cancer who experience inadequate pain relief during optimized chronic opioid therapy.  
Scientific Title of Study
Modification(s)  
A double blind, randomized, placebo controlled, parallel group dose-range exploration study of Sativex® in relieving pain in patients with advanced cancer, who experience inadequate analgesia during optimized chronic opioid therapy. 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
GWCA0701  Protocol Number 
NCT00530764  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query

Modification(s)  
Name  Dr Shoibal Mukherjee 
Designation  Director – Clinical Operations 
Affiliation  Quintiles Research (India) Private Limited 
Address  8th Floor, DLF Square M Block, Jacaranda Marg DLF City Phase II Gurgaon, Haryana India - 122002

Gurgaon
HARYANA
122002
India 
Phone  91-7838652395  
Fax    
Email  shoibal.mukherjee@quintiles.com  
 
Details of Contact Person
Public Query

Modification(s)  
Name  Suchela Srivatsa 
Designation  Director – Clinical Operations  
Affiliation  Quintiles Research India Pvt. Ltd. 
Address  301-A-1, Leela Business Park MV Road, Andheri East, Mumbai 400059

Mumbai
MAHARASHTRA
400059
India 
Phone  91-9820712114  
Fax  91-22-56774343  
Email  suchela.srivatsa@quintiles.com  
 
Source of Monetary or Material Support
Modification(s)  
GW Pharma Ltd. Porton Down Science Park Salisbury, Wiltshire SP4 0JQ, United Kingdom 
 
Primary Sponsor
Modification(s)  
Name  GW Pharma Ltd 
Address  Porton Down Science ParkSalisbury,Wiltshire SP4 0JQ,United Kingdom 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor
Modification(s)  
Name  Address 
Quintiles Research India Private Limited   B-101-106, Shapath IV, Opp. Karnavati Club, Sarkhej – Gandhinagar Road, Ahmedabad 380 051 
 
Countries of Recruitment
Modification(s)  
  Canada
Czech Republic
Finland
India
Italy
Romania
South Africa
Spain
United States of America  
Sites of Study
Modification(s)  
No of Sites = 21  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr. Sushma Bhatnagar  All India Institute of Medical Sciences  Room No 242, ,Ansari Nagar, -110 029
New Delhi
DELHI 
011-26588227
011-26588408
shumob@yahoo.com 
Dr. SVSS Prasad   Apollo Hospital  Jubilee Hills, ,-500 033
Hyderabad
ANDHRA PRADESH 
040-23554720
040-23543270
hydaherf@gmail.com 
Dr. Niti Narang  Bangalore Institute of Oncology  #8, P.Kalinga Road, ,Sampangi Ram Nagar, -560 027
Bangalore
KARNATAKA 
09342991298
080-41479772
nitiraizada@yahoo.co.uk 
Dr. Pushpalata Guptha  Bhagwaan Mahaveer Cancer Hospital And Research Centre  Jawaharlal Nehru Marg, ,Near Saras Diary, Malviya Nagar, -302 017
Jaipur
RAJASTHAN 
0141-2700107
0141-2709716
pushp_anil@yahoo.co.in 
Dr. Chirag Desai   CBCC-Apollo Hospital  Block A, Village Bhat, ,Plot 1A, GiDC Estate, -382 428
Gandhinagar
GUJARAT 
09824047561
079-66701876
chiragdesai.oncology@gamil.com 
Dr. Rakesh Taran   CHL-Apollo Hospitals  Opp. Anoop Nagar, ,Near L.I.G. Triangle, -452 008
Indore
MADHYA PRADESH 
0731-2549090
0731-4245625
madhu@chlapollo.com 
Dr. Chetan Deshmukh   Deenanath Mangeshkar Hospital and Research Centre  Erandwane, ,-411 004
Pune
MAHARASHTRA 
020-66023000
020-66023025
drchetandeshmukh@rediffmail.com 
Dr. Praveen Kumar   Dharmshila Cancer Hospital & Research Centre  Vasundhara Enclave, ,Bhajan Pura, -110 096
New Delhi
DELHI 
011-22617771, 011-22617772, 011-22617773
011-22619033
drpraveenkb@yahoo.com 
Dr. Sharanbasappa Nirni   Indo American Cancer Institute and Research Centre  Road No.14, ,Banjara Hills, -500 034
Hyderabad
ANDHRA PRADESH 
040-23551235
040-23542120
nirni2002@rediffmail.com 
Dr. Tarini Prasad Sahoo  Jawaharlal Nehru Cancer Hospital  Idgah Hills, ,P.B.No. 32, -462 001
Bhopal
MADHYA PRADESH 
0755-2665720
0755-2738325
tarini73@rediffmail.com 
Dr. Madhurai Lokapur  Jehangir Clinical Development Centre Pvt.Ltd.  Jahangir Hospital Premises ,32, Sasson Road, -411 001
Pune
MAHARASHTRA 
020 26059318
020-26059319
madhulok@yahoo.com 
Dr. Purvesh Parikh   Kashyap Oncology Centre,   Imperial mahal dadar TT, ,Khodadad Circle, -400014
Mumbai
MAHARASHTRA 
09821097752
022 2417 6980
purvish1@gmail.com 
Dr. Kirushna Kumar   Meenakshi Mission Hospital & Research Centre  Lake Area, ,Melur Road, -625 107
Madurai
TAMIL NADU 
0452-2588741
0452-4219030
drkskk@yahoo.com 
Dr. C Sairam  MNJ institute of Oncology  Red Hills, ,-500 004
Hyderabad
ANDHRA PRADESH 
040-24150428
040-2415042
drsairamc@yahoo.co.in 
Dr. Rangaraju Rangarao   Rajiv Gandhi Cancer Institute and Research Centre  Sector-5, ,Rohini, -110085
New Delhi
DELHI 
011-47022440
011-27051037
ranga_rr@vsnl.net 
Dr. Rejnish Kumar   Regional Cancer Centre  P.O.Box 2417, ,Medical College Campus, -695 011

 
0471-2522239
0471-2443814
rejnish@yahoo.com 
Dr. Kamlesh Bokil   Ruby Hall Clinic  40, Sasson Road, ,-411 001
Pune
MAHARASHTRA 
020-6123391 020- 5440633 Extn: 5124
020-26121185
kamleshbokil@hotmail.com 
Dr. Suresh Advani   S.L.Raheja Hospital  Raheja Rugnalaya Marg, ,Fisherman Colony, Raheja Hospial Road, Mahim, -400 016
Mumbai
MAHARASHTRA 
022-66529999
022-24449418
shadvani2000@yahoo.com 
Dr Maheboob Basade   Saifee Hospital  15/17, ,M. Karve Road, -400 004
Mumbai
MAHARASHTRA 
09821062692
022-67570111
basade@gmail.com 
Dr. Anish Maru   Seroc Cancer Centre  S.K.Soni Hospital, ,Sector 5, Vidhyadhar Nagar, Main Sikhar Road, -302 013
Jaipur
RAJASTHAN 
0141-2232409
0141-2232412
anishmaru@yahoo.com 
Dr. A.V.Suresh   Yashoda Hospital  Room No 34, ,Somajiguda, Raj Bhavan Road, -500 082
Hyderabad
ANDHRA PRADESH 
040-23319999
040-23312783
sureshattili@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 21  
Name of Committee  Approval Status 
Apollo Hospitals - Ethics Committee, CHL-Apollo Hospitals, Indore-Dr. Rakesh Taran  Approved 
Dharamshila Hospital and Research Centre Ethics Committee, Delhi  Submittted/Under Review 
Ethical Review Board, Meenakshi Mission Hospital and Research Centre, Madurai- Dr. KiruShna Kumar  Approved 
Ethics Committee, Apollo Health City ,Apollo Hospitals,Jubilee Hills, Hyderabad - Dr. S S V V Prasad  Approved 
Ethics Committee, Bhagwan Mahaveer Cancer Hospital & Research Centre, Jaipur- Dr. Pushpalata Gupta  Approved 
Ethics Committee, Poona Medical Research Foundation, Ruby Hall Clinic, Pune-Dr. K P Bokil  Approved 
Ethics Committee, Saifee Hospital, Mumbai- Dr. Maheboob Basade  Approved 
Ethics Committee, Yashoda Academy of Medical Education and Research, Secunderabad- Dr. A V Suresh  Approved 
Ethics Committee-Apollo Hospitals International Limited, Gandhinagar- Dr. Chirag Desai  Approved 
HCG-Central Ethics Committee, Bangalore- Dr. Niti Riazada Narang  Approved 
Hirabai Cowasji Jehangir Medical Research Institute and Jehangir Clinical Development Centre Ethics Committee , Jehangir Hospital, Pune - Dr. Madhuri Lokapur  Approved 
Human Ethics Committee, Regional Cancer Centre, Thiruvananthapuram  Approved 
ICON Ethics Committee, Mumbai- Dr. Purvish Parikh  Approved 
Institutinal Ethics Committee,Jawaharlal Nehru Cancer Hospital, Bhopal- Dr. Tarini Prasad Sahoo  Approved 
Institutional Ethics Committee, All India Institute of Medical Sciences, New Delhi- Dr. Sushma Bhatnagar  Approved 
Institutional Ethics Committee, Deenanath Mangeshkar Hospital & Research Centre, Pune  Approved 
Institutional Ethics Committee, Indo American Cancer Institute & Research Centre, Hyderabad- Dr. S S Nirni  Approved 
Institutional Ethics Committee, MNJ Institute of Oncology & Regional Cancer Center, Hyderabad- Dr. C. Sairam  Approved 
Institutional Review Board, Rajiv Gandhi Institute and Research Centre, New Delhi  Approved 
Institutional Review Board, S.L.Raheja Hospital, Mumbai  Submittted/Under Review 
Searoc Ethics Committee,S. K. Soni Hospital, Jaipur- Dr. Anish Maru  Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Cancer pain 
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Comparator Agent  Name: Placebo   Mode of Administration: Oromucosal Spray Maximum duration of treatment of a subject according to protocol: 5 weeks  
Intervention  Sativex  Oromucosal Spray, Maximum duration of treatment of a subject according to protocol: 5 weeks 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Day(s)
Age To  99.00 Day(s)
Gender  Both 
Details  - The patient has advanced active cancer for which there is no known curative therapy.
- The patient is able (in the investigators opinion) and willing to comply with all study requirements.
- The patient has a clinical diagnosis of cancer related pain, which is not wholly alleviated with their current opioid treatment.
- The patient is receiving a sustained release (SR) fixed dose of opioid therapy (excluding Methadone). N.B. The opiate therapy must be Step III according to the WHO analgesic ladder.
- The patient is willing to continue to take their regular daily baseline opioid regimen (SR) at the same dose, throughout the duration of study.
 
 
ExclusionCriteria 
Details  - The patient should be excluded from entering study if they have received or are due to receive during the study period; chemotherapy, hormone therapy or radiotherapy, which, in the opinion of the investigator will affect their pain. - Any history or immediate family history of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition. - Any known or suspected history of a diagnosed dependence disorder, current heavy alcohol consumption, current use of an illicit drug or current non prescribed use of any prescription drug. - The patient has poorly controlled epilepsy or recurrent seizures (i.e. at least one year since last seizure). - The patient has experienced myocardial infarction or clinically relevant cardiac dysfunction within the last 12 months or has a cardiac disorder that, in the opinion of the investigator would put the patient at risk of a clinically relevant arrhythmia or myocardial infarction.  
 
Method of Generating Random Sequence
Modification(s)  
Computer generated randomization 
Method of Concealment
Modification(s)  
Centralized 
Blinding/Masking
Modification(s)  
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
The primary endpoint is the patient 30% pain response status, where a response is defined as a 30% or greater reduction in the IVRS 11-point Numeric Rating Scale pain score (average pain).   During conduct of the study 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
- Cumulative average pain response curves
- Mean daily IVRS NRS pain score (average and also worst pain).
- Brief Pain Inventory - Short Form
- Sleep Disruption NRS
- Patient Assessment of Constipation Quality of Life (PAC-QoL)
- Patient Global Impression of Change - PGIC
- Montgomery Asberg Depression Rating Scale (MADRS)
- Addiction Research Center Inventory (ARCI)  
During conduct of the study 
 
Target Sample Size
Modification(s)  
Total Sample Size="336"
Sample Size from India="60" 
Phase of Trial
Modification(s)  
Phase 2 
Date of First Enrollment (India)
Modification(s)  
No Date Specified 
Date of First Enrollment (Global)  16/11/2007 
Estimated Duration of Trial
Modification(s)  
Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
None 
Brief Summary
Modification(s)  
This nine week (5 to 14 day baseline and five weeks treatment period, followed by a two week follow up visit), multi-center, double blind, randomized, placebo controlled, dose ranging study will aim to determine the effective dose range and to demonstrate a non-effective dose range of Sativex in patients with advanced cancer, who experience inadequate analgesia during optimized chronic opioid therapy. The study will include a five-week double blind treatment period incorporating one week of titration after which patients will remain on a stable dose of treatment where possible. The primary endpoint is the patient 30% pain response status, where a response is defined as a 30% or greater reduction in the IVRS 11- point Numeric Rating Scale pain score (average pain). Globally 336 patients are planned to be enrolled in this study. From India,approximately 60 patients are planned to be enrolled. The anticipated date of first patient enrollement in India can be October 12, 2009. As of July 30, 2009, 219 patients have been enrolled and 145 patients have completed the study. 
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