NCT00674609 - A Study of Sativex® for Pain Relief in Patients With Advanced Malignancy | Biotech Hunter

Enrollment

177

Participants

Timeline

Start Date

February 28, 2002

Primary Completion Date

February 29, 2004

Study Completion Date

March 31, 2004

Conditions

Palliative CarePainCancer

Interventions

DRUG

Placebo

Containing colourants and excipients. Subjects received study medication delivered in 100 µl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations in 24 hours.

DRUG

Sativex®

Containing D9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml. Subjects received study medication delivered in 100 µl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours.

DRUG

THC Alone

Containing THC, 27 mg/ml, as extract of Cannabis sativa L. Subjects received study medication delivered in 100 µl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg) in 24 hours.

Trial Locations (1)

SY3 8HS

Shropshire and Mid-Wales Hospice, Shrewsbury