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CTRI Number  CTRI/2012/12/003169 [Registered on: 03/12/2012] Trial Registered Prospectively
Last Modified On: 30/06/2016
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   Long Term Safety of Sativex® Oromucosal Spray (Sativex®; Nabiximols) as Adjunctive Therapy in Patients With Uncontrolled Persistent Chronic Cancer Related Pain  
Scientific Title of Study   A Multicenter, Non-comparative, Open-label Extension Study to Assess the Long Term Safety of Sativex® Oromucosal Spray (Nabiximols) as Adjunctive Therapy in Patients With Uncontrolled Persistent Chronic Cancer-related Pain 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
2009-016529-32  EudraCT 
Protocol Number:GWCA0999, Version 3 dated 01 Jun 2011  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mr Tarun Pandotra 
Designation  Director, Clinical Operations 
Affiliation  PRA International  
Address  B 402, Business Square,
Andheri Kurla Road, Chakala, Andheri (E)
Mumbai (Suburban)
MAHARASHTRA
400093
India 
Phone  912240309578  
Fax  912240309134  
Email  PandotraTarun@praintl.com  
 
Details of Contact Person
Scientific Query  
Name  Mr Tarun Pandotra 
Designation  Director, Clinical Operations 
Affiliation  PRA International  
Address  B 402, Business Square,
Andheri Kurla Road, Chakala, Andheri (E)
Mumbai (Suburban)
MAHARASHTRA
400093
India 
Phone  912240309578  
Fax  912240309134  
Email  PandotraTarun@praintl.com  
 
Details of Contact Person
Public Query  
Name  Mr Tarun Pandotra 
Designation  Director, Clinical Operations 
Affiliation  PRA International  
Address  B 402, Business Square,
Andheri Kurla Road, Chakala, Andheri (E)
Mumbai (Suburban)
MAHARASHTRA
400093
India 
Phone  912240309578  
Fax  912240309134  
Email  PandotraTarun@praintl.com  
 
Source of Monetary or Material Support  
GW Pharmaceuticals PORTON DOWN SCIENCE PARK SALISBURY WILTSHIRE SP4 0JQ, United kingdom 
Otsuka Pharmaceutical Development Commercialization Inc 2440 Research Blvd Rockville, MD 20850 USA  
 
Primary Sponsor  
Name  GW Pharmaceuticals Ltd 
Address  PORTON DOWN SCIENCE PARK SALISBURY WILTSHIRE SP4 0JQ, United Kingdom 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Otsuka Pharmaceutical Development Commercialization Inc  2440 Research Blvd Rockville, MD 20850 USA  
Pharmaceutical Research Associates India Pvt  B 402, Business Square, Andheri Kurla Road, Chakala, Mumbai - 400 093. India 
 
Countries of Recruitment     Australia
Belgium
Bulgaria
Czech Republic
Estonia
Germany
Hungary
India
Israel
Italy
Latvia
Lithuania
Mexico
Poland
Republic of Korea
Romania
Spain
Taiwan
United Kingdom
United States of America  
Sites of Study
Modification(s)  
No of Sites = 15  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sushma Bhatnagar  AIIMS, New Delhi  Room No. 242, 2nd Floor, Dr. BRA, IRCH, New Delhi
New Delhi
DELHI 		 919811326453
911126588227
shumob@yahoo.com 
Dr Praveen Kumar Bansal  Asian Institute of Medical Sciences  Badkal Flyover Road, Sector -21 A, Faridabad- 121001
Faridabad
HARYANA 		 919891707655
911294143716
drpraveenkb@yahoo.com 
Dr Pushplata Gupta  Bhagwan Mahaveer Cancer Hospital & research Centre  Department of Oncology, JLN Marg, Mauriya Nagar, Jaipur-302017, Rajasthan, India.
Jaipur
RAJASTHAN 		 919829098288
911412709716
pushp-anil@yahoo.co.in 
Dr Rangaraju Rangarao  BLK Hospital, New Delhi  Pusa Road, New Delhi- 110029
New Delhi
DELHI 		 919811326453

rangaraor@airtel.blackberry.com 
Dr Chetan Deshmukh  Deenanath Mangeshkar Hospital & Research Centre  Department of Oncology, Erandawane, Near Mhatre Bridge, Pune-411004, Maharashtra, India
Pune
MAHARASHTRA 		 919850811449
912066023025
drchetandeshmukh@gmail.com 
Dr Anish Maru  Dharamshila Hospital & Research Center (DHRC), Delhi  Dharamshila Marg, Mayur Vihar Phase- I , Vasundhara Enclave, Delhi- 110096
East
DELHI 		 919811254969
911122617770
anishmaru@yahoo.com 
Dr Durgaprasad Gorijavolu  Indo-American Cancer Institute and Research Centre  Road no: 14, Banjarahills, Hyderabad- 500 034
Hyderabad
ANDHRA PRADESH 		 919848212569
914023550015
durgaoncodr@yahoo.co.uk 
Dr Madhuri Lokapur  Jehangir Clinical Development Centre Pvt.Ltd., Pune  Jehangir Hospital Premices, 32 Sassoon Road, Pune- 411001
Pune
MAHARASHTRA 		 919822097478
912026059319
madhulok@yahoo.com 
Dr Akhil Deka  Karnataka Cancer Therapy and Research Institute  Nava Nagar, Dharwad Road, Hubli
Dharwad
KARNATAKA 		 918362228217
918362322063
akhil_deka@rediffmail.com 
Dr Nalini Kilara  M.S. Ramaiah Medical College and Hospital  New BEL Road, MSRIT Post , Bangalore – 560054
Bangalore
KARNATAKA 		 919845089482
918023601983
drnalini.msr@gmail.com 
Dr Amish Vora  Max Super Speciality Hospital  2 Press Enclave Road, Saket, New Delhi
New Delhi
DELHI 		 919818474003
911126565060
amish.vora@maxhealthcare.com 
Dr Kirushna Kumar  Meenakshi Mission Hospital and Research Centre, Madurai  Lake Area, Melur Road, Madurai- 625107
Madurai
TAMIL NADU 		 919787713004
914522586353
drkskk@yahoo.com 
Dr Sanjeeva Kumari Chinta  Mehdi Nawaz Jung Institute of Oncology and Regional Cancer Centre  Red Hills, Lakadi ka pul, Hyderabad- 500004
Hyderabad
ANDHRA PRADESH 		 919848820404
914023314063
sanjeevakumari@hotmail.com 
Dr Shoba Nair  Saint Johns Medical College and Hospital  Dept. of Paina and Palliative Care, Sarjapur Road, Koramgala, Bangalore- 560034, Karnataka
Bangalore
KARNATAKA 		 919743107123

nair.shoba@gmail.com 
Dr Haritha Chiramana  Shree Krishna Hospital and Medical Research Center  Gokalnagar, Karamsad-388325
Anand
GUJARAT 		 919427042969
912692222411
ritu80@rediffmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 11  
Name of Committee  Approval Status 
Ethical Review Board – Meenakshi Mission Hospital and Research Centre, Madurai.  Submittted/Under Review 
Ethical Review Board– M.S. Ramaiah Medical College and Hospitals  Submittted/Under Review 
Ethics Committee – BLK Superspeciality Hospital, New Delhi.  Approved 
Ethics Committee – Dharamshila Hospital & Research Centre, Delhi.  Submittted/Under Review 
Ethics Committee, Bhagwan Mahaveer Cancer Hospital & Research Centre, Jaipur  Approved 
Human Research Ethics committee  Submittted/Under Review 
Institution Ethics Committee, AIIMS, New Delhi  Approved 
Institutional Ethical Review Board, St. Johns Medical College Hospital, Bangalore.  Submittted/Under Review 
Institutional Ethics Committee Basavatarakam Indo American Cancer Hospital & Research Institute  Submittted/Under Review 
Institutional Ethics Committee, Deenanath Mangeshkar Hospital & Research Centre, Pune  Submittted/Under Review 
Jehangir Clinical Development Centre Institutional Review Board, Pune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  patients with uncontrolled persistent chronic cancer related pain,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  N/A  N/A 
Intervention  Sativex oromucosal spray (Sativex®; Nabiximols)  Oromucosal spray, containing THC (27 mg/mL): CBD (25 mg/mL), in ethanol: propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each actuation (100 μL) delivers THC 2.7 mg and CBD 2.5 mg. Duartion of therapy and frequency of therapy: 6 months and daily  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patient has completed the parent study within the last seven days
2. Willing and able to give written informed consent
3. Willing and able to comply with all study requirements
 
 
ExclusionCriteria 
Details  1. The patient is currently using cannabis or cannabinoid based medications, other than the parent study IMP, and is unwilling to abstain for the duration of the study
2. 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
3. Any known or suspected history of a substance abuse/dependence disorder (including opiate abuse/dependence prior to the diagnosis of cancer)
4. Has poorly controlled epilepsy or recurrent seizures (i.e. one or more seizure during the last year)
5. Has experienced myocardial infarction or clinically significant 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 significant arrhythmia or myocardial infarction
6. Has significantly impaired renal function
7. Has significantly impaired hepatic function
8. Female patients of child-bearing potential and male patients whose partner is of child-bearing potential, unless willing to ensure that they or their partner use effective contraception, for example, oral contraception, double barrier, intra-uterine device, during the study and for three months thereafter (however, a male condom should not be used in conjunction with a female condom as this may not prove effective)
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Incidence of adverse events (AEs)  Incidence of adverse events (AEs) 
 
Secondary Outcome  
Outcome  TimePoints 
Columbia Suicide Severity Rating Scale (C-SSRS)  Time Frame: 6 months  
Vital Signs   Time Frame: 6 months  
Hematology and Biochemistry Assessments   Time Frame: 6 months  
Weekly average NRS Pain   Time Frame: 6 months  
Weekly average Sleep Disruption NRS   Time Frame: 6 months  
Constipation NRS   Time Frame: 6 months  
Patient Satisfaction Questionnaire (PSQ)   Time Frame: 6 months  
 
Target Sample Size   Total Sample Size="800"
Sample Size from India="65" 
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)   25/02/2013 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  19/01/2011 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="4"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Other (Terminated) 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Clinical study GWCA0999 is a six month, Phase III, non-comparative, follow-on study to evaluate the safety of long-term Sativex therapy in patients with advanced cancer.

Primary Objective is to evaluate the safety of long-term Sativex therapy when used as an adjunctive (not breakthrough) measure in patients with advanced cancer.

 

Secondary Objectives are to assess the maintenance of effect through long-term usage of Sativex as adjunctive therapy for the relief of uncontrolled persistent chronic cancer related pain.

 

In India thousands of cases related to cancer pain are reported every year. This molecule has been studied previously and there are no concerns with respect to the safety profile of the molecule. The conduct of this study in India will help generate data on ’safety’ & ’maintenance of effect’ of Sativex. The data will support the use of Sativex oromucosal spray (Sativex®; Nabiximols) as adjunctive therapy in relieving uncontrolled persistent chronic pain in patients with advanced cancer who have inadequate analgesia even with optimized chronic opioid therapy.

 

This trial is likely to benefit about 65 patients that will participate in the study and further may provide a new treatment to patients with cancer pain if the molecule is found to be successful.

 

 
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