Clinical trial NCT01337089: Long Term Safety of Sativex Oromucosal Spray (Sativex®; Nabiximols) as Adjunctive Therapy in Patients With Uncontrolled Persistent Chronic Cancer Related Pain
Official title: A Multicenter, Non-comparative, Open-label Extension Study to Assess the Long Term Safety of Sativex® Oromucosal Spray (Sativex®; Nabiximols) as Adjunctive Therapy in Patients With Uncontrolled Persistent Chronic Cancer Related Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Advanced Cancer
Keywords: Cancer pain
Opioid therapy
Inadequate analgesia
Optimized chronic opioid therapy
Lead sponsor: Jazz Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Otsuka Pharmaceutical Development & Commercialization, Inc.
First posted: 2011-04-18
Enrollment: 660
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: This was a 6-month, multicenter, non-comparative, OLE study to evaluate the safety of long-term nabiximols use as an adjunctive measure in participants with advanced cancer. The study provided continued availability of nabiximols to participants who completed a preceding double-blind phase 3 study and de novo participants. Consenting eligible participants entered the extension study (Day 1) on the same day as the "end of treatment" visit of a parent study or within 7 days of the "end of treatment" visit or on the day of the "safety follow-up visit" of the parent study. The "safety follow-up" visit of a parent study was performed on the same day as Day 1, if the participant did not enter the OLE study on the same day as the "end of treatment" visit of a parent study. De novo participants attended a screening visit 3 to 14 days prior to enrollment (Day 1). All participants commenced dosing on Day 1. Further study visits took place after 2 weeks (Day 15), and every 4 weeks thereafter until the end of treatment period on Day 183 or earlier if the participant withdrew from the study.

Treatment was started as a single spray in the evening on the first day (Day 1). Participants then gradually titrated by 1 additional spray per day to an individualized dose, balancing efficacy and tolerability. Participants had to complete titration within 14 days of their first dose of study drug and then continue at the same dose for the remainder of the study.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Percent Of Participants With Treatment-emergent Adverse Events
timeFrame: Baseline, Day 183
Secondary outcomes:
measure: Change From Baseline In Mean NRS Average Pain During The Last Period
timeFrame: Baseline, Last Period (Days 156-183) or last 27 days of treatment
measure: Change From Baseline In Mean Sleep Disruption NRS During The Last Period
timeFrame: Baseline, Last Period (Days 156-183) or last 27 days of treatment
measure: Patient Satisfaction Questionnaire At Last Visit (Up To Day 183)
timeFrame: Last Visit (up to Day 183)
measure: Change From Baseline In NRS Constipation At Last Visit (Up To Day 183)
timeFrame: Baseline, Last Visit (up to Day 183)
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: El Cajon
country: United States
state: California
city: Gilroy
country: United States
state: California
city: Glendale
country: United States
state: California
city: Santa Rosa
country: United States
state: California
city: Clearwater
country: United States
state: Florida
city: Daytona Beach
country: United States
state: Florida
city: Holiday
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Lynn Haven
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Stuart
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Winter Park
country: United States
state: Florida
city: Marietta
country: United States
state: Georgia
city: Newnan
country: United States
state: Georgia
city: Stockbridge
country: United States
state: Georgia
city: Woodlawn
country: United States
state: Illinois
city: Ashland
country: United States
state: Kentucky
city: Bossier City
country: United States
state: Louisiana
city: Shreveport
country: United States
state: Louisiana
city: Saint Louis Park
country: United States
state: Minnesota
city: Kansas City
country: United States
state: Missouri
city: Missoula
country: United States
state: Montana
city: Berlin
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Flat Rock
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Houston
country: United States
state: Texas
city: Laredo
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: Lacey
country: United States
state: Washington
city: Parkville
country: Australia
city: Bruxelles
country: Belgium
city: Gabrovo
country: Bulgaria
city: Varna
country: Bulgaria
city: Vratsa
country: Bulgaria
city: Benešov
country: Czechia
city: Jablonec Nad Nisou
country: Czechia
city: Most
country: Czechia
city: Nová Ves Pod Pleší
country: Czechia
city: Ostrava
country: Czechia
city: Plzen
country: Czechia
city: Sokolov
country: Czechia
city: Teplice
country: Czechia
city: České Budějovice
country: Czechia
city: České Budějovice
country: Czechia
city: Berlin
country: Germany
city: Frankfurt
country: Germany
city: Jena
country: Germany
city: Lunen
country: Germany
city: Stadtroda
country: Germany
city: Wetzlar
country: Germany
city: Wiesbaden
country: Germany
city: Deszk
country: Hungary
city: Komarom
country: Hungary
city: Miskolc
country: Hungary
city: Nyíregyháza
country: Hungary
city: Szekszard
country: Hungary
city: Szikszo
country: Hungary
city: Beer Sheva
country: Israel
city: Haifa
country: Israel
city: Ramat Gan
country: Israel
city: Zerifin
country: Israel
city: Garbagnate Milanese
country: Italy
city: Piacenza
country: Italy
city: Torino
country: Italy
city: Riga
country: Latvia
city: Rēzekne
country: Latvia
city: Klaipeda
country: Lithuania
city: Siauliai
country: Lithuania
city: Vilnius
country: Lithuania
city: Chihuahua
country: Mexico
city: Distrito Federal
country: Mexico
city: Białystok
country: Poland
city: Bielsko-Biala
country: Poland
city: Bydgoszcz
country: Poland
city: Czeladz
country: Poland
city: Częstochowa
country: Poland
city: Częstochowa
country: Poland
city: Działdowo
country: Poland
city: Gdansk
country: Poland
city: Gliwice
country: Poland
city: Klodzko
country: Poland
city: Opole
country: Poland
city: Ostrowiec Swietokrzyski
country: Poland
city: Poznan
country: Poland
city: Warszawa
country: Poland
city: Warszawa
country: Poland
city: Wloclawek
country: Poland
city: Ponce
country: Puerto Rico
city: San Juan
country: Puerto Rico
city: Baia Mare
country: Romania
city: Baia Mare
country: Romania
city: Braila
country: Romania
city: Bucuresti
country: Romania
city: Bucuresti
country: Romania
city: Cluj-Napoca
country: Romania
city: Constanţa
country: Romania
city: Craiova
country: Romania
city: Focsani
country: Romania
city: Iaşi
country: Romania
city: Oradea
country: Romania
city: Satu Mare
country: Romania
city: Sibiu
country: Romania
city: Suceava
country: Romania
city: Târgovişte
country: Romania
city: Granada
country: Spain
city: Taichung
country: Taiwan
city: Tainan City
country: Taiwan
city: Bury Saint Edmunds
country: United Kingdom
city: Bury
country: United Kingdom
city: Cheltenham
country: United Kingdom
city: Crumpsall
country: United Kingdom
city: Edinburgh
country: United Kingdom
city: Edinburgh
country: United Kingdom
city: Gorleston-on-Sea
country: United Kingdom
city: Leeds
country: United Kingdom
city: Manchester
country: United Kingdom
city: Norwich
country: United Kingdom
city: Plymouth
country: United Kingdom
city: Weston-super-Mare
country: United Kingdom
city: Withington
country: United Kingdom
Study officials:
References: