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Brief Title: 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 ID: NCT01337089
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
, 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
, Bruxelles, , Belgium
, Gabrovo, , Bulgaria
, Varna, , Bulgaria
, Vratsa, , Bulgaria
, Benešov, , Czechia
, Jablonec Nad Nisou, , Czechia
, Most, , Czechia
, Nová Ves Pod Pleší, , Czechia
, Ostrava, , Czechia
, Plzen, , Czechia
, Sokolov, , Czechia
, Teplice, , Czechia
, České Budějovice, , Czechia
, České Budějovice, , Czechia
, Berlin, , Germany
, Frankfurt, , Germany
, Jena, , Germany
, Lunen, , Germany
, Stadtroda, , Germany
, Wetzlar, , Germany
, Wiesbaden, , Germany
, Deszk, , Hungary
, Komarom, , Hungary
, Miskolc, , Hungary
, Nyíregyháza, , Hungary
, Szekszard, , Hungary
, Szikszo, , Hungary
, Beer Sheva, , Israel
, Haifa, , Israel
, Ramat Gan, , Israel
, Zerifin, , Israel
, Garbagnate Milanese, , Italy
, Piacenza, , Italy
, Torino, , Italy
, Riga, , Latvia
, Rēzekne, , Latvia
, Klaipeda, , Lithuania
, Siauliai, , Lithuania
, Vilnius, , Lithuania
, Chihuahua, , Mexico
, Distrito Federal, , Mexico
, Białystok, , Poland
, Bielsko-Biala, , Poland
, Bydgoszcz, , Poland
, Czeladz, , Poland
, Częstochowa, , Poland
, Częstochowa, , Poland
, Działdowo, , Poland
, Gdansk, , Poland
, Gliwice, , Poland
, Klodzko, , Poland
, Opole, , Poland
, Ostrowiec Swietokrzyski, , Poland
, Poznan, , Poland
, Warszawa, , Poland
, Warszawa, , Poland
, Wloclawek, , Poland
, Ponce, , Puerto Rico
, San Juan, , Puerto Rico
, Baia Mare, , Romania
, Baia Mare, , Romania
, Braila, , Romania
, Bucuresti, , Romania
, Bucuresti, , Romania
, Cluj-Napoca, , Romania
, Constanţa, , Romania
, Craiova, , Romania
, Focsani, , Romania
, Iaşi, , Romania
, Oradea, , Romania
, Satu Mare, , Romania
, Sibiu, , Romania
, Suceava, , Romania
, Târgovişte, , Romania
, Granada, , Spain
, Taichung, , Taiwan
, Tainan City, , Taiwan
, Bury Saint Edmunds, , United Kingdom
, Bury, , 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