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Spray Study Information|
SPRAY Study Information
What is the SPRAY Study?
The SPRAY study is a phase II clinical trial for patients whose pain is not adequately managed by current pain medication. The study is looking at whether an investigational medication, Sativex®, is effective in managing persistent cancer pain. It is being conducted at approximately 65 research sites globally (33 in the United States) and approximately 336 patients will be enrolled.
This research study, will evaluate Sativex® as an add-on treatment for persistent cancer pain for
possible approval by the U.S. Food and Drug Administration (FDA). Sativex® has been approved in
Canada as an add-on treatment for pain in patients with cancer.
Why is the SPRAY study being conducted?
Battling cancer is its own challenge. But when you also have to fight the persistent pain associated
with cancer, the challenges you face can be overwhelming.
Persistent pain associated with cancer causes discomfort, sleeplessness, and inability to do day-to-day activities. Doctors typically prescribe medications—such as morphine and oxycodone—for persistent cancer pain relief. However, even with increased medication dosage, some patients still experience constant pain. Additionally, these drugs often include unwanted side effects that prevent patients from taking the higher doses needed to help relieve their persistent pain. Because of this, it is important to develop additional treatments to combat persistent cancer pain.
Who is eligible to participate?
In order to participate in this study, cancer patients must be 18 years of age or older and:
* Have a clinical diagnosis of persistent cancer pain
* Be currently taking opioid treatments (such as morphine or oxycodone) but
still having trouble
managing pain
* Have no known or suspected dependency disorder, such as heavy alcohol consumption,
current
use of an illicit drug, or current non-prescribed use of any prescription drug
Additional requirements for study eligibility will be assessed by the study doctor.
What can participants expect?
SPRAY study participants will be randomly assigned (like flipping a coin) to receive either Sativex®
or placebo (a mouth spray that does not contain any active medication). There is a 3 out of 4
chance of receiving Sativex®.
Sativex® or the placebo is taken orally by spraying it into your mouth (like a breath freshener) on the inside of your cheeks. All participants will take Sativex® or the placebo in addition to taking their current medications.
Participation in the SPRAY study will last approximately 9 weeks, which includes 4 visits to the study
site where medical tests and evaluations will be performed. In addition, participants will need to call
an automated telephone number every day to document their level of pain, sleep disruption (if any),
and opioid and study medication usage.
Qualified participants will receive study-related medical evaluations, tests, and Sativex® or placebo.
In addition, participants will be reimbursed for time and travel.
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