| CTRI Number |
CTRI/2012/11/003160 [Registered on: 30/11/2012] Trial Registered Prospectively |
| Last Modified On: |
30/06/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Two-Part Study of Sativex� Oromucosal Spray for Relieving Uncontrolled Persistent Pain at any site of cancer related pain in Patients With Advanced Cancer
|
|
Scientific Title of Study
|
A Two-part, Placebo-controlled, Study of the Safety and Efficacy 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. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2010-022905-17 |
EudraCT |
| GWCA1103- Version 2, dated 16 May 2011 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
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 |
02240309578 |
| Fax |
02240309134 |
| Email |
PandotraTarun@praintl.com |
|
Details of Contact Person
Scientific Query
|
| Name |
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 |
02240309578 |
| Fax |
02240309134 |
| Email |
PandotraTarun@praintl.com |
|
Details of Contact Person
Public Query
|
| Name |
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 |
02240309578 |
| Fax |
02240309134 |
| Email |
PandotraTarun@praintl.com |
|
|
Source of Monetary or Material Support
|
| GW Pharmaceuticals Ltd
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
UK |
| 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 Ltd |
B 402, Business Square, Andheri Kurla Road,
Chakala, Mumbai - 400 093. India |
|
|
Countries of Recruitment
|
Australia
India
Israel
Italy
Republic of Korea
Spain
Taiwan
United States of America |
|
Sites of Study
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sushma Bhatnagar |
AIIMS, New Delhi |
AAIMS, Room No. 242, 2nd Floor, Dr. BRA, IRCH, New Delhi, Delhi, India
New Delhi
DELHI |
919811326453
911126588227
shumob@yahoo.com |
| Dr Pushplata Gupta |
Bhagwan Mahaveer Cancer Hospital & research Centre |
Deaprtment of Oncology,JLN Marg, Mauriya Nagar, Jaipur-302017, Rajasthan, India
Jaipur
RAJASTHAN |
919829098288
91412709716
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 Madhuri Lokapur |
Jehangir Clinical Development Centre Pvt.Ltd., Pune |
Jehangir Hospital Premices, 32 Sassoon Road, Pune- 411001
Pune
MAHARASHTRA |
919822097478
911122617770
anishmaru@yahoo.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 Shoba Nair |
Saint Johns Medical College and Hospital, Bangalora |
Dept. of Paina and Palliative Care, Sarjapur Road, Koramgala, Bangalore- 560034, Karnataka
Bangalore
KARNATAKA |
919743107123
nair.shoba@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Ethical Review Board – Meenakshi Mission Hospital and Research Centre, Madurai. |
Approved |
| 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 |
| Institution Ethics Committee, AIIMS, New Delhi |
Approved |
| Institutional Ethical Review Board, St. Johns Medical College Hospital, Bangalore. |
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
patients with advanced cancer, who have inadequate analgesia even with optimized chronic opioid therapy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
GA0034 (Placebo) |
Oromucosal spray, containing ethanol:propylene glycol:50) excipients, with peppermint 0.05%) flavoring and colorings FD&C Yellow No.5 (E102 tartrazine)(0.0260%), FD&C Yellow No.6 (E110 sunset yellow) (0.0038%),FD&C Red No. 40 (E129 Allura red AC)0.00330%) and FD&C Blue No.1 (E133 Brilliant blue FCF)(0.00058%). All study arm patients would be receiving standard pain therapy as well as prescribed by the investigator. Total duration of therapy for patients that complete the study will be 7 weeks |
| Intervention |
Sativex oromucosal spray |
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 delivers THC 2.7 mg and CBD 2.5 mg. All study arm patients would be receiving standard pain therapy as well as prescribed by the investigator. Total duration of therapy for patients that complete the study will be 7 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. The patient has advanced cancer for which there is no known curative therapy.
2. The patient has a clinical diagnosis of cancer related pain, which is not alleviated with their current optimized opioid treatment
3. The patient is receiving an optimized maintenance dose of Step III opioid therapy, preferably with a sustained release preparation, but also allowing a regular maintenance dose of around the clock use of immediate release preparations
4. The patient is receiving a daily maintenance dose Step III opioid therapy of less than or equal to a total daily opioid dose of 500 mg/day of morphine equivalence (including maintenance and break-through opioids)
5. The patient is using no more than one type of break-through opioid analgesia
|
|
| ExclusionCriteria |
| Details |
1. Have any planned clinical interventions that would affect their pain (e.g., chemotherapy or radiation therapy where, in the clinical judgment of the investigator, these would be expected to affect pain)
2. The patient is currently using or has used cannabis or cannabinoid based medications within 30 days of study entry and is unwilling to abstain for the duration of the study
3. 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
4.Has significantly impaired renal function
5. Has significantly impaired hepatic function
6. 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
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean 11-point NRS average pain score over the last four days of the Part B treatment period (end of treatment) taken from the IVRS |
Mean 11-point NRS average pain score over the last four days of the Part B treatment period (end of treatment) taken from the IVRS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Percentage improvement in NRS average pain score from baseline to the end of treatment |
Time Frame: 7 weeks |
| Mean 11-point NRS worst pain score from baseline to the end of treatment |
Time Frame: 7 weeks |
| Mean sleep disruption NRS score from baseline to the end of treatment |
Time Frame: 7 weeks |
|
|
Target Sample Size
|
Total Sample Size="540"
Sample Size from India="162"
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)
|
17/12/2012 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
31/08/2012 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="11"
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 GWCA1103 is a Phase III therapeutic confirmatory study, of up to 11 weeks duration, to be carried out in patients with advanced cancer and who are experiencing cancer-related pain that is not fully alleviated by their current opioid therapy. They are patients who are likely to have a limited life expectancy. GWCA1103 is a two-part (Part A and B), placebo-controlled, study of the safety and efficacy of Sativex oromucosal spray (Sativex®; Nabiximols). The study’s primary objective is to evaluate the efficacy of Sativex, compared with placebo, when used as an adjunctive measure, in relieving uncontrolled persistent chronic pain (not breakthrough pain) in patients with advanced cancer, who have inadequate analgesia even with optimized chronic opioid therapy.
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 & efficacy 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 162 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.
|