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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01424566
Recruitment Status : Completed
First Posted : August 29, 2011
Last Update Posted : July 6, 2016
Otsuka Pharmaceutical Development & Commercialization, Inc.
Information provided by (Responsible Party):
GW Pharmaceuticals Ltd.

Brief Summary:

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 or disease Intervention/treatment Phase
Pain Advanced Cancer Drug: Sativex® Drug: Placebo (product code GA0034) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 406 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
Study Start Date : January 2012
Actual Primary Completion Date : July 2015
Actual Study Completion Date : December 2015

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Percentage improvement in NRS average pain score from baseline to the end of treatment [ Time Frame: 7 weeks ]
  2. Mean 11-point NRS worst pain score from baseline to the end of treatment [ Time Frame: 7 weeks ]
  3. Mean sleep disruption NRS score from baseline to the end of treatment [ Time Frame: 7 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01424566

  Hide Study Locations
Auchenflower, Australia, 4066
Bowral, Australia, 2576
Bruce, Australia, 2617
Clayton, Australia, 3168
Daw Park, Australia, 5041
East Melbourne, Australia, 3002
Fitzroy, Australia, 3065
Frankston, Australia, 3199
Kingswood, Australia, 2747
Parkville, Australia, 3050
Waratah, Australia, 2298
Gabrovo, Bulgaria, 5300
Shumen, Bulgaria, 9700
Sofia, Bulgaria, 1303
Varna, Bulgaria, 9010
Vratza, Bulgaria, 3000
Santiago de Chile, Chile, 7500000
Vandoeuvre les Nancy, France, 54511
Frankfurt, Germany, 60311
Lunen, Germany, 44534
Stradtroda, Germany, 07646
Wetzlar, Germany, 35578
Budapest, Hungary, 84-88
Deszk, Hungary, H-6772
Kassai, Hungary, 45-49
Komarum, Hungary, 2900
Nyíregyháza, Hungary, 4412
Szekszard, Hungary, 7100
Bangalore, India, 560027
Bangalore, India, 560034
Bengaluru, India, 560038
Chennai, India, 600035
Delhi, India, 110096
Gurgaon, India, 122001
Indore, India, 452008
Jaipur, India, 302004
Jaipur, India, 302013
Jaipur, India, 302017
Karamsad, India, 388325
Lucknow, India, 226003
Madurai, India, 625107
Mumbai, India, 400004
Nashik, India, 422004
New Delhi, India, 110018
New Delhi, India, 110029
Pune, India, 411004
Ashkelon, Israel, 78306
Beer Sheva, Israel, 84101
Haifa, Israel, 31096
Jerusalem, Israel, 91120
Ramat Gan, Israel, 52621
Tel Aviv, Israel, 64239
Zerifin, Israel, 60930
Bergamo, Italy, 24100
Bologna, Italy, 40100
Brescia, Italy, 2127
Cantania, Italy
Chieti, Italy, 66100
Cremona, Italy, 26100
Garbagnate Milanese, Italy, 20024
L'Aquila, Italy, 67100
Mantova, Italy, 46100
Novara, Italy, 28100
Piacenza, Italy, 29100
Roma, Italy, 00186
Torino, Italy, 10126
Korea, Republic of
Anyang, Korea, Republic of, 431-070
Busan, Korea, Republic of, 602-715
Busan, Korea, Republic of, 602-739
Hwasun, Korea, Republic of, 519-763
Seoul, Korea, Republic of, 120-752
Seoul, Korea, Republic of, 136-705
Klaipeda, Lithuania, LT-92288
Siauliai, Lithuania, LT-76307
Vilnius, Lithuania, LT-08660
Bielsko-Biala, Poland, 43-300
Bydgoszcz, Poland, 85-796
Czeladź, Poland, 41-250
Gdansk, Poland, 80-208
Gliwice, Poland, 44-101
Klodzko, Poland, 57-300
Opole, Poland, 45-272
Ostrowiec Swietokrzyski, Poland, 27-400
Poznan, Poland, 61-245
Warsaw, Poland, 02-793
Warszawa, Poland, 02-781
Wloclawek, Poland, 87-800
Alba, Romania, 510077
Braila, Romania, 810325
Bucuresti, Romania, 010976
Bucuresti, Romania, 011461
Judet Bihor, Romania, 410469
Maramures, Romania, 430241
Satu Mare, Romania, 440055
Sibiu, Romania, 550245
Suceava, Romania, 720237
Vrancea, Romania, 620165
Almeira, Spain, 04120
Barcelona, Spain, 08907
Cadiz, Spain, 11009
Carrascal de Barregas, Spain, 37129
Granada, Spain, 18014
Huelva, Spain, 21005
Logroño, Spain, 26001
Madrid, Spain, 28040
Madrid, Spain, 28050
Oviedo, Spain, 33006
Sevilla, Spain, 41013
Sevilla, Spain, 41092
Teruel, Spain, 44002
Valencia, Spain, 46009
Zafra, Spain, 06300
Changhua city, Taiwan, 500
Kaohsiung, Taiwan, 80099
Taichung, Taiwan, 404
Taichung, Taiwan, 40705
Tainan City, Taiwan, 73657
Taipei, Taiwan, 10449
Taipei, Taiwan, 11217
Taipei, Taiwan, 11490
United Kingdom
Bury St Edmunds, United Kingdom, IP33 2QZ
Edinburgh, United Kingdom, EH42XU
Glasgow, United Kingdom, G12 0YN
Leeds, United Kingdom, LS17 6QD
Manchester, United Kingdom, M20 4BX
Norwich, United Kingdom, NR4 7UY
Sponsors and Collaborators
GW Pharmaceuticals Ltd.
Otsuka Pharmaceutical Development & Commercialization, Inc.

Responsible Party: GW Pharmaceuticals Ltd. Identifier: NCT01424566     History of Changes
Other Study ID Numbers: GWCA1103
2010-022905-17 ( EudraCT Number )
First Posted: August 29, 2011    Key Record Dates
Last Update Posted: July 6, 2016
Last Verified: July 2016

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

Additional relevant MeSH terms:
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents