Long Term Safety of Sativex Oromucosal Spray (Sativex®; Nabiximols) as Adjunctive Therapy in Patients With Uncontrolled Persistent Chronic Cancer Related Pain

NCT01337089 | Completed Phase 3 Results DMC

• 2 other identifiers: GWCA09992009-016529-32
• Study Type: interventional
• Target: 660
• Locations: 18 countries
• Sites: 128

Brief Summary

This was a six-month open-label extension (OLE) study to evaluate the safety of long-term nabiximols (Sativex®) therapy when used as an adjunctive treatment in participants with advanced cancer. The study provided continued availability of nabiximols to participants who completed a preceding Phase 3 study and new (de novo) participants.

Conditions

Pain; Advanced Cancer

Keywords

Cancer pain; Opioid therapy; Inadequate analgesia; Optimized chronic opioid therapy

Outcome Measures

Primary Outcomes (1)

• Percent Of Participants With Treatment-emergent Adverse Events

  Treatment-emergent Adverse Events (TEAEs) were coded according to the Medical Dictionary for Regulatory Activities (MedDRA) dictionary version 17.0. A TEAE is defined as an adverse event with an onset after the start of study drug treatment. The percent of participants who experienced one or more TEAEs is reported.

  Baseline, Day 183

Secondary Outcomes (4)

• Change From Baseline In Mean NRS Average Pain During The Last Period

  Baseline, Last Period (Days 156-183) or last 27 days of treatment

• Change From Baseline In Mean Sleep Disruption NRS During The Last Period

  Baseline, Last Period (Days 156-183) or last 27 days of treatment

• Patient Satisfaction Questionnaire At Last Visit (Up To Day 183)

  Last Visit (up to Day 183)

• Change From Baseline In NRS Constipation At Last Visit (Up To Day 183)

  Baseline, Last Visit (up to Day 183)

Study Arms (1)

Non-comparative, open-label Nabiximols

EXPERIMENTAL

Nabiximols was self-administered by participants as a 100 microliter (μL) oromucosal spray, in the morning and evening, up to a maximum of 10 sprays per day for 6 months. Nabiximols oromucosal spray contained delta-9-tetrahydrocannabinol (THC) (27 milligrams \[mg\]/milliliter \[mL\]):cannabidiol (CBD) (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.

Drug: Nabiximols

Interventions

Nabiximols DRUG

Also known as: Sativex®

Non-comparative, open-label Nabiximols

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant had completed the parent study within the last seven days
• Willing and able to give written informed consent
• Willing and able to comply with all study requirements

You may not qualify if:

• The participant was using cannabis or cannabinoid based medications, other than the parent study investigational medicinal product (IMP), and was unwilling to abstain for the duration of the study
• 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 substance abuse/dependence disorder (including opiate abuse/dependence prior to the diagnosis of cancer), current heavy alcohol consumption (more than 60 grams \[g\] of pure alcohol per day for men, and more than 40 g of pure alcohol per day for women), current use of an illicit drug or current non-prescribed use of any prescription drug
• Had poorly controlled epilepsy or recurrent seizures (for example, one or more seizure during the last year)
• Had experienced myocardial infarction or clinically significant cardiac dysfunction within the last 12 months or had a cardiac disorder that, in the opinion of the investigator would have put the participant at risk of a clinically significant arrhythmia or myocardial infarction
• Had significantly impaired renal function
• Had significantly impaired hepatic function at the "end of treatment" visit of the parent study
• Female participants of child-bearing potential and male participants whose partner was of child-bearing potential, unless willing to ensure that they or their partner used effective contraception, for example, oral contraception, double barrier, intra-uterine device, during the study and for 3 months thereafter (however, a male condom should not have been used in conjunction with a female condom as this may not have proven effective)

Sponsors & Collaborators

• Jazz Pharmaceuticals: lead
• Otsuka Pharmaceutical Development & Commercialization, Inc.: collaborator

Study Sites (128)

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Phoenix, Arizona, 85018, United States

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Phoenix, Arizona, 85028, United States

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El Cajon, California, 92020, United States

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Gilroy, California, 95020, United States

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Glendale, California, 91204, United States

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Santa Rosa, California, 95403, United States

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Clearwater, Florida, 33756, United States

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Daytona Beach, Florida, 32117, United States

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Holiday, Florida, 34691, United States

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Jacksonville, Florida, 32257, United States

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Lynn Haven, Florida, 32444, United States

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Miami, Florida, 33136, United States

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Stuart, Florida, 34994, United States

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Tampa, Florida, 33609, United States

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Winter Park, Florida, 32789, United States

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Marietta, Georgia, 30060, United States

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Newnan, Georgia, 30265, United States

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Stockbridge, Georgia, 30281, United States

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Woodlawn, Illinois, 62898, United States

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Ashland, Kentucky, 41101, United States

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Bossier City, Louisiana, 71111, United States

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Shreveport, Louisiana, 71105, United States

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Saint Louis Park, Minnesota, 55426, United States

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Kansas City, Missouri, 64132, United States

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Missoula, Montana, 59802, United States

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Berlin, New Jersey, 08009, United States

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New York, New York, 10003, United States

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New York, New York, 10010, United States

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Flat Rock, North Carolina, 28731, United States

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Winston-Salem, North Carolina, 27103, United States

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Cleveland, Ohio, 44119, United States

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Philadelphia, Pennsylvania, 19146, United States

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Houston, Texas, 77089, United States

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Laredo, Texas, 78041, United States

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Salt Lake City, Utah, 84112, United States

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Salt Lake City, Utah, 84124, United States

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Lacey, Washington, 98503, United States

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Parkville, 3050, Australia

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Brussels, 1000, Belgium

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Gabrovo, 5300, Bulgaria

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Varna, 9010, Bulgaria

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Vratsa, 3000, Bulgaria

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Benešov, 25601, Czechia

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České Budějovice, 370 01, Czechia

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České Budějovice, 370 87, Czechia

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Jablonec nad Nisou, 46601, Czechia

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Most, 434 64, Czechia

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Nová Ves pod Pleší, 262 04, Czechia

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Ostrava, 708 52, Czechia

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Pilsen, 304 60, Czechia

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Sokolov, 356 01, Czechia

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Teplice, 415 01, Czechia

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Berlin, 10435, Germany

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Frankfurt, 60311, Germany

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Jena, 07747, Germany

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Lünen, 44534, Germany

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Stadtroda, 07646, Germany

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Wetzlar, 35578, Germany

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Wiesbaden, 65189, Germany

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Deszk, 6772, Hungary

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Komárom, 2900, Hungary

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Miskolc, 3501, Hungary

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Nyíregyháza, 4412, Hungary

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Szekszárd, 7100, Hungary

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Szikszó, 3800, Hungary

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Beersheba, 84101, Israel

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Haifa, 31096, Israel

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Ramat Gan, 52621, Israel

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Ẕerifin, 60930, Israel

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Garbagnate Milanese, 20024, Italy

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Piacenza, 29100, Italy

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Torino, 10126, Italy

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Rēzekne, 4600, Latvia

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Riga, 1038, Latvia

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Klaipėda, 92288, Lithuania

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Šiauliai, 76307, Lithuania

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Vilnius, 08660, Lithuania

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Chihuahua City, 31238, Mexico

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Distrito Federal, 10700, Mexico

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Bialystok, 15-250, Poland

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Bielsko-Biala, 43-300, Poland

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Bydgoszcz, 85-796, Poland

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Czeladź, 41-250, Poland

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Częstochowa, 42-200, Poland

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Częstochowa, 42-217, Poland

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Działdowo, 13-200, Poland

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Gdansk, 80-208, Poland

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Gliwice, 44-101, Poland

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Kłodzko, 57-300, Poland

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Opole, 45-272, Poland

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Ostrowiec Świętokrzyski, 27-400, Poland

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Poznan, 61-245, Poland

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Warsaw, 02-781, Poland

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Warsaw, 02-793, Poland

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Włocławek, 87-800, Poland

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Ponce, 00717, Puerto Rico

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San Juan, 00927, Puerto Rico

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Baia Mare, 430031, Romania

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Baia Mare, 430241, Romania

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Brăila, 810325, Romania

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Bucharest, 010976, Romania

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Bucharest, 011461, Romania

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Cluj-Napoca, 400015, Romania

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Constanța, 900591, Romania

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Craiova, 200385, Romania

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Focşani, 620165, Romania

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Iași, 700106, Romania

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Oradea, 410469, Romania

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Satu Mare, 440055, Romania

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Sibiu, 550245, Romania

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Suceava, 720237, Romania

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Târgovişte, 130095, Romania

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Granada, 18014, Spain

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Taichung, 404, Taiwan

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Tainan, 73657, Taiwan

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Bury, BL9 7TD, United Kingdom

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Bury St Edmunds, IP33 2QZ, United Kingdom

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Cheltenham, GL53 0QJ, United Kingdom

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Crumpsall, M8 5RB, United Kingdom

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Edinburgh, EH4 2XR, United Kingdom

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Edinburgh, United Kingdom

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Gorleston-on-Sea, NR31 6LA, United Kingdom

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Leeds, LS17 6QD, United Kingdom

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Manchester, M20 4BX, United Kingdom

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Norwich, NR4 7UY, United Kingdom

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Plymouth, PL6 8DH, United Kingdom

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Weston-super-Mare, BS23 4TQ, United Kingdom

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Withington, M20 4BX, United Kingdom

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MeSH Terms

Conditions

Pain; Cancer Pain

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Medical Enquiries
• Organization: GW Pharmaceuticals Ltd.

medinfo.USA@gwpharm.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2011
• First Posted: April 18, 2011
• Study Start: January 19, 2011
• Primary Completion: January 27, 2016
• Study Completion: January 27, 2016
• Last Updated: April 12, 2023
• Results First Posted: April 23, 2018

Record last verified: 2023-04

Locations

IL (4); IT (3); BU (3); CZ (10); DE (7); LI (3); RO (15); BE (1); US (37); GB (13); ME (2); HU (6); AU (1); PL (16); ES (1); LA (2); PR (2); TW (2)