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

NCT ID: NCT01337089

Last Updated: 2023-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 660 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-19
• Study Completion Date: 2016-01-27

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.

Conditions

Pain; Advanced Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Non-comparative, open-label Nabiximols

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.

Group Type: EXPERIMENTAL

Nabiximols

Intervention Type: DRUG

Interventions

Nabiximols

Intervention Type: DRUG

Other Intervention Names

Sativex®

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

Sponsor Role: collaborator

Jazz Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Phoenix, Arizona, United States

Phoenix, Arizona, United States

El Cajon, California, United States

Gilroy, California, United States

Glendale, California, United States

Santa Rosa, California, United States

Clearwater, Florida, United States

Daytona Beach, Florida, United States

Holiday, Florida, United States

Jacksonville, Florida, United States

Lynn Haven, Florida, United States

Miami, Florida, United States

Stuart, Florida, United States

Tampa, Florida, United States

Winter Park, Florida, United States

Marietta, Georgia, United States

Newnan, Georgia, United States

Stockbridge, Georgia, United States

Woodlawn, Illinois, United States

Ashland, Kentucky, United States

Bossier City, Louisiana, United States

Shreveport, Louisiana, United States

Saint Louis Park, Minnesota, United States

Kansas City, Missouri, United States

Missoula, Montana, United States

Berlin, New Jersey, United States

New York, New York, United States

New York, New York, United States

Flat Rock, North Carolina, United States

Winston-Salem, North Carolina, United States

Cleveland, Ohio, United States

Philadelphia, Pennsylvania, United States

Houston, Texas, United States

Laredo, Texas, United States

Salt Lake City, Utah, United States

Salt Lake City, Utah, United States

Lacey, Washington, United States

Parkville, , Australia

Brussels, , Belgium

Gabrovo, , Bulgaria

Varna, , Bulgaria

Vratsa, , Bulgaria

Benešov, , Czechia

České Budějovice, , Czechia

České Budějovice, , Czechia

Jablonec nad Nisou, , Czechia

Most, , Czechia

Nová Ves pod Pleší, , Czechia

Ostrava, , Czechia

Pilsen, , Czechia

Sokolov, , Czechia

Teplice, , Czechia

Berlin, , Germany

Frankfurt, , Germany

Jena, , Germany

Lünen, , Germany

Stadtroda, , Germany

Wetzlar, , Germany

Wiesbaden, , Germany

Deszk, , Hungary

Komárom, , Hungary

Miskolc, , Hungary

Nyíregyháza, , Hungary

Szekszárd, , Hungary

Szikszó, , Hungary

Beersheba, , Israel

Haifa, , Israel

Ramat Gan, , Israel

Ẕerifin, , Israel

Garbagnate Milanese, , Italy

Piacenza, , Italy

Torino, , Italy

Rēzekne, , Latvia

Riga, , Latvia

Klaipėda, , Lithuania

Šiauliai, , Lithuania

Vilnius, , Lithuania

Chihuahua City, , Mexico

Distrito Federal, , Mexico

Bialystok, , Poland

Bielsko-Biala, , Poland

Bydgoszcz, , Poland

Czeladź, , Poland

Częstochowa, , Poland

Częstochowa, , Poland

Działdowo, , Poland

Gdansk, , Poland

Gliwice, , Poland

Kłodzko, , Poland

Opole, , Poland

Ostrowiec Świętokrzyski, , Poland

Poznan, , Poland

Warsaw, , Poland

Warsaw, , Poland

Włocławek, , Poland

Ponce, , Puerto Rico

San Juan, , Puerto Rico

Baia Mare, , Romania

Baia Mare, , Romania

Brăila, , Romania

Bucharest, , Romania

Bucharest, , Romania

Cluj-Napoca, , Romania

Constanța, , Romania

Craiova, , Romania

Focşani, , Romania

Iași, , Romania

Oradea, , Romania

Satu Mare, , Romania

Sibiu, , Romania

Suceava, , Romania

Târgovişte, , Romania

Granada, , Spain

Taichung, , Taiwan

Tainan City, , Taiwan

Bury, , United Kingdom

Bury St Edmunds, , United Kingdom

Cheltenham, , United Kingdom

Crumpsall, , United Kingdom

Edinburgh, , United Kingdom

Edinburgh, , United Kingdom

Gorleston-on-Sea, , United Kingdom

Leeds, , United Kingdom

Manchester, , United Kingdom

Norwich, , United Kingdom

Plymouth, , United Kingdom

Weston-super-Mare, , United Kingdom

Withington, , United Kingdom

Countries

United States; Australia; Belgium; Bulgaria; Czechia; Germany; Hungary; Israel; Italy; Latvia; Lithuania; Mexico; Poland; Puerto Rico; Romania; Spain; Taiwan; United Kingdom

Other Identifiers

2009-016529-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GWCA0999

Identifier Type: -

Identifier Source: org_study_id