The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: Sativex® for Relieving Persistent Pain in Participants With Advanced Cancer
Official Title: A Double Blind, Randomized, Placebo-controlled, Parallel Group Study of Sativex Oromucosal Spray (Sativex®; Nabiximols) as Adjunctive Therapy in Relieving Uncontrolled Persistent Chronic Pain in Patients With Advanced Cancer, Who Experience Inadequate Analgesia During Optimized Chronic Opioid Therapy
Study ID: NCT01262651
Brief Summary: This 9-week study aimed to determine the efficacy, safety and tolerability of nabiximols (Sativex®) as an adjunctive treatment, compared with placebo in relieving uncontrolled persistent chronic pain in participants with advanced cancer. Eligible participants were not required to stop any of their current treatments or medications.
Detailed Description: This 9-week, multi-center, double-blind, randomized, placebo-controlled study aimed to determine the efficacy, safety and tolerability of nabiximols, administered as an adjunctive treatment for 5 weeks, versus placebo. Eligible participants had advanced cancer, with a clinical diagnosis of cancer related pain which was not wholly alleviated by their current optimized opioid treatment. Qualifying participants entered the study at screening and commenced a 5 to 14 day eligibility period. During this period, eligible participants had 3 consecutive days where pain severity remained within defined parameters, break-through opioid usage had not exceeded an average of 4 episodes per day, and maintenance opioid medication and dose had not changed. Eligible participants returned for randomization on Day 1 and were randomized to either the nabiximols or placebo treatment arm using a 1:1 allocation ratio. Participants began an initial titration period that lasted up to 14 days. The titration schedule required dosing to a minimum of 3 sprays per day, after which participants were allowed to individualize their dose (3 to 10 sprays per day) until Day 14 when that dose was then fixed for the remainder of the study. Participants returned at Day 22 and Day 36 (end of the randomized treatment period), or earlier if they terminated prematurely from the study. After the end of the 5-week treatment period, participants were offered the option of entering an open-label extension (OLE) study; a safety follow up visit (up to Day 43) was not required if the participant entered the OLE on Day 36. Participants who entered the OLE, up to 7 days after study completion had their follow-up assessments performed on the same day as their first OLE study visit. Participants that did not enter the OLE study had a safety follow up visit 14 days after treatment completion, which could be via telephone.
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
, Brandon, Florida, United States
, Daytona Beach, Florida, United States
, Holiday, Florida, United States
, Jacksonville, Florida, United States
, Lynn Haven, Florida, United States
, Stuart, Florida, United States
, Winter Park, Florida, United States
, Newnan, Georgia, United States
, Stockbridge, Georgia, United States
, Shreveport, Louisiana, United States
, Saint Louis Park, Minnesota, United States
, Kansas City, Missouri, United States
, Berlin, New Jersey, United States
, Hendersonville, North Carolina, United States
, Winston-Salem, North Carolina, United States
, Philadelphia, Pennsylvania, United States
, Houston, Texas, United States
, Houston, Texas, United States
, Laredo, Texas, United States
, Salt Lake City, Utah, United States
, Salt Lake City, Utah, United States
, Bruxelles, , Belgium
, Gabrovo, , Bulgaria
, Shumen, , Bulgaria
, Varna, , Bulgaria
, Ceske Budejovice, , Czechia
, Ceske Budejovice, , Czechia
, Hradec Kralove, , Czechia
, Most, , Czechia
, Nová Ves Pod Pleší, , Czechia
, Ostrava-Poruba, , Czechia
, Plzen, , Czechia
, Lunen, , Germany
, Stadtroda, , Germany
, Wetzlar, , Germany
, Deszk, , Hungary
, Kecskemét, , Hungary
, Komarom, , Hungary
, Miskolc, , Hungary
, Nyíregyháza, , Hungary
, Szekszard, , Hungary
, Rezekne, , Latvia
, Riga, , Latvia
, Klaipeda, , Lithuania
, Siauliai, , Lithuania
, Vilnius, , Lithuania
, Bialystok, , Poland
, Bielsko-Biala, , Poland
, Gliwice, , Poland
, Poznan, , Poland
, Warszawa, , Poland
, Ponce, , Puerto Rico
, San Juan, , Puerto Rico
, Baia Mare, , Romania
, Braila, , Romania
, Bucuresti, , Romania
, Craiova, , Romania
, Oradea, , Romania
, Satu Mare, , Romania
, Suceava, , Romania
, Bury Saint Edmunds, , United Kingdom
, Bury, , United Kingdom
, Edinburgh, , United Kingdom
, Glasgow, , United Kingdom
, Manchester, , United Kingdom
, Norwich, , United Kingdom
, Weston Super Mare, , United Kingdom
, Wolverhampton, , United Kingdom