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A Two-Part Study of Sativex® Oromucosal Spray for Relieving Uncontrolled Persistent Pain in Patients With Advanced Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by GW Pharmaceuticals Ltd.
Sponsor:
Collaborator:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Information provided by (Responsible Party):
GW Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier:
NCT01424566
First received: August 25, 2011
Last updated: November 4, 2014
Last verified: January 2014
  Purpose

The primary objective of this study is to determine the efficacy of Sativex, compared with placebo, an adjunctive medication in relieving persistent chronic pain (not breakthrough pain) in patients with advanced cancer, who have this pain even when they are on optimized/maximized chronic opioid therapy.

This multi-center study will be conducted in two parts. All participants enrolled into the trial will receive Sativex during one of two parts of the study, but they will not know which part.

Eligible patients will not be required to stop any of their current treatments or medications.


Condition Intervention Phase
Pain
Advanced Cancer
Drug: Sativex®
Drug: Placebo (product code GA0034)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by GW Pharmaceuticals Ltd.:

Primary Outcome Measures:
  • 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 [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage improvement in NRS average pain score from baseline to the end of treatment [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
  • Mean 11-point NRS worst pain score from baseline to the end of treatment [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
  • Mean sleep disruption NRS score from baseline to the end of treatment [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 540
Study Start Date: January 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sativex® Treatment Drug: Sativex®
100 μl oromucosal spray administered twice daily up to a maximum of 10 sprays per day
Other Names:
  • Sativex® oromucosal spray
  • Nabiximols
Placebo Comparator: Placebo Treatment Drug: Placebo (product code GA0034)
Matching placebo: oromucosal spray, containing excipients, peppermint flavored
Other Name: Product code GA0034

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria (abbreviated):

  • The patient has advanced cancer for which there is no known curative therapy
  • The patient has a clinical diagnosis of cancer related pain, which is not alleviated with their current optimized opioid treatment
  • 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
  • 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)
  • The patient is using no more than one type of break-through opioid analgesia

Exclusion Criteria (abbreviated):

  • 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)
  • 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
  • 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
  • Has significantly impaired renal function
  • Has significantly impaired hepatic function
  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01424566

Contacts
Contact: SPRAY Study Information SPRAYInfo@mmgct.com

  Hide Study Locations
Locations
Australia
Not yet recruiting
Auchenflower, Australia, 4066
Recruiting
Bowral, Australia, 2576
Not yet recruiting
Bruce, Australia, 2617
Not yet recruiting
Clayton, Australia, 3168
Not yet recruiting
Daw Park, Australia, 5041
Completed
East Melbourne, Australia, 3002
Recruiting
Fitzroy, Australia, 3065
Completed
Frankston, Australia, 3199
Not yet recruiting
Kingswood, Australia, 2747
Recruiting
Parkville, Australia, 3050
Not yet recruiting
Waratah, Australia, 2298
Chile
Not yet recruiting
Santiago de Chile, Chile, 7500000
France
Not yet recruiting
Vandoeuvre les Nancy, France, 54511
Germany
Recruiting
Frankfurt, Germany, 60311
Recruiting
Lunen, Germany, 44534
Recruiting
Stradtroda, Germany, 07646
Recruiting
Wetzlar, Germany, 35578
Hungary
Recruiting
Deszk, Hungary, H-6772
Recruiting
Komarum, Hungary, 2900
Recruiting
Nyíregyháza, Hungary, 4412
Recruiting
Szekszard, Hungary, 7100
India
Recruiting
Bangalore, India, 560034
Not yet recruiting
Bangalore, India, 560027
Not yet recruiting
Bengaluru, India, 560038
Not yet recruiting
Chennai, India, 600035
Not yet recruiting
Delhi, India, 110096
Not yet recruiting
Gurgaon, India, 122001
Not yet recruiting
Indore, India, 452008
Not yet recruiting
Jaipur, India, 302013
Recruiting
Jaipur, India, 302017
Not yet recruiting
Jaipur, India, 302004
Not yet recruiting
Karamsad, India, 388325
Not yet recruiting
Lucknow, India, 226003
Recruiting
Madurai, India, 625107
Not yet recruiting
Mumbai, India, 400004
Not yet recruiting
Nashik, India, 422004
Not yet recruiting
New Delhi, India, 110029
Not yet recruiting
New Delhi, India, 110018
Recruiting
Pune, India, 411004
Israel
Recruiting
Ashkelon, Israel, 78278
Recruiting
Beer Sheva, Israel, 84101
Recruiting
Haifa, Israel, 31096
Recruiting
Jerusalem, Israel, 91120
Recruiting
Ramat Gan, Israel, 52621
Completed
Tel Aviv, Israel, 64239
Recruiting
Zerifin, Israel, 60930
Italy
Not yet recruiting
Bergamo, Italy, 24100
Not yet recruiting
Bologna, Italy, 40100
Completed
Brescia, Italy, 2127
Not yet recruiting
Cantania, Italy
Recruiting
Chieti, Italy, 66100
Recruiting
Cremona, Italy, 26100
Not yet recruiting
Cremona, Italy, 26100
Recruiting
Garbagnate Milanese, Italy, 20024
Not yet recruiting
L'Aquila, Italy, 67100
Not yet recruiting
Mantova, Italy, 46100
Not yet recruiting
Novara, Italy, 28100
Recruiting
Piacenza, Italy, 29100
Not yet recruiting
Roma, Italy, 00186
Recruiting
Torino, Italy, 10126
Korea, Republic of
Not yet recruiting
Anyang, Korea, Republic of, 431-070
Not yet recruiting
Busan, Korea, Republic of, 602-739
Not yet recruiting
Busan, Korea, Republic of, 602-715
Not yet recruiting
Hwasun, Korea, Republic of, 519-763
Not yet recruiting
Seoul, Korea, Republic of, 120-752
Not yet recruiting
Seoul, Korea, Republic of, 136-705
Lithuania
Recruiting
Klaipeda, Lithuania, LT-92288
Recruiting
Siauliai, Lithuania, LT-76307
Recruiting
Vilnius, Lithuania, LT-08660
Poland
Recruiting
Bielsko-Biala, Poland, 43-300
Recruiting
Bydgoszcz, Poland, 85-796
Recruiting
Czeladź, Poland, 41-250
Recruiting
Częstochowa, Poland, 42-217
Recruiting
Gdansk, Poland, 80-208
Recruiting
Gliwice, Poland, 44-101
Recruiting
Klodzko, Poland, 57-300
Recruiting
Ostrowiec Swietokrzyski, Poland, 27-400
Recruiting
Poznan, Poland, 61-245
Recruiting
Warsaw, Poland, 02-793
Recruiting
Warszawa, Poland, 02-781
Recruiting
Wloclawek, Poland, 87-800
Romania
Recruiting
Braila, Romania, 810325
Recruiting
Bucuresti, Romania, 010976
Recruiting
Judet Bihar, Romania, 410469
Recruiting
Maramures, Romania, 430241
Recruiting
Satu Mare, Romania, 440055
Recruiting
Suceava, Romania, 720237
Spain
Not yet recruiting
Almeira, Spain, 04120
Not yet recruiting
Barcelona, Spain, 08907
Recruiting
Cadiz, Spain, 11009
Recruiting
Carrascal de Barregas, Spain, 37129
Recruiting
Granada, Spain, 18014
Not yet recruiting
Huelva, Spain, 21005
Not yet recruiting
Logroño, Spain, 26001
Recruiting
Madrid, Spain, 28046
Not yet recruiting
Madrid, Spain, 28040
Not yet recruiting
Oviedo, Spain, 33006
Completed
Sevilla, Spain, 41013
Not yet recruiting
Sevilla, Spain, 41092
Not yet recruiting
Teruel, Spain, 44002
Not yet recruiting
Valencia, Spain, 46009
Not yet recruiting
Zafra, Spain, 06300
Taiwan
Recruiting
Changhua city, Taiwan, 500
Completed
Kaohsiung, Taiwan, 80099
Recruiting
Taichung, Taiwan, 40705
Completed
Taichung, Taiwan, 404
Recruiting
Tainan City, Taiwan, 73657
Recruiting
Taipei, Taiwan, 10449
Recruiting
Taipei, Taiwan, 10099
Recruiting
Taipei, Taiwan, 11217
United Kingdom
Recruiting
Bury St Edmunds, United Kingdom, IP33 2QZ
Recruiting
Edinburgh, United Kingdom, EH42XU
Recruiting
Manchester, United Kingdom, M20 4BX
Recruiting
Norwich, United Kingdom, NR4 7UY
Sponsors and Collaborators
GW Pharmaceuticals Ltd.
Otsuka Pharmaceutical Development & Commercialization, Inc.
  More Information

No publications provided

Responsible Party: GW Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT01424566     History of Changes
Other Study ID Numbers: GWCA1103, 2010-022905-17
Study First Received: August 25, 2011
Last Updated: November 4, 2014
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GW Pharmaceuticals Ltd.:
cancer pain
opioid therapy
inadequate analgesia
optimized chronic opioid therapy

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014