A Study of Sativex® for Pain Relief in Patients With Advanced Malignancy. (SPRAY)

Jazz Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Cancer; Pain; Palliative Care

Treatments: Drug: Sativex Medium Dose; Drug: Sativex Low Dose; Drug: Sativex High Dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT00530764

GWCA0701

Details and patient eligibility

About

The purpose of this study is to determine the effective dose range and to demonstrate a non-effective dose range of Sativex in patients with advanced cancer, who experience inadequate pain relief even though they are on optimized chronic opioid therapy.

Enrollment: 360 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patient has advanced active cancer for which there is no known curative therapy.
• The patient is able (in the investigators opinion) and willing to comply with all study requirements.
• The patient has a clinical diagnosis of cancer related pain, which is not wholly alleviated with their current opioid treatment.
• The patient is receiving a sustained release (SR) fixed dose of opioid therapy (excluding Methadone). N.B. The opiate therapy must be Step III according to the World Health Organization (WHO) analgesic ladder.
• The patient is willing to continue to take their regular daily baseline opioid regimen (SR) at the same dose, throughout the duration of study.

Exclusion criteria

• The patient should be excluded from entering study if they have received or are due to receive during the study period; chemotherapy, hormone therapy or radiotherapy, which, in the opinion of the investigator will affect their pain.
• 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 diagnosed dependence disorder, current heavy alcohol consumption, current use of an illicit drug or current non prescribed use of any prescription drug.
• The patient has poorly controlled epilepsy or recurrent seizures (i.e. at least one year since last seizure).
• The patient has experienced myocardial infarction or clinically relevant cardiac dysfunction within the last 12 months or has a cardiac disorder that, in the opinion of the investigator would put the patient at risk of a clinically relevant arrhythmia or myocardial infarction.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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360 participants in 4 patient groups

Sativex Low Dose

Experimental group

Description:

Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.

Treatment:

Drug: Sativex Low Dose

Sativex Medium Dose

Experimental group

Description:

Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.

Treatment:

Drug: Sativex Medium Dose

Sativex High Dose

Experimental group

Description:

Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.

Treatment:

Drug: Sativex High Dose

Placebo

No Intervention group

Description:

Range of 1-16 sprays per day of placebo spray.