PLACEBO RESPONSE REDUCTION

PLACEBO RESPONSE REDUCTION
If you are running a pain trial involving an analgesic medication
and want to minimize “noise” from your trial, the
Placebo Response Reduction Program can help.
WHAT: Set of training materials for subjects and staff on neutral
expectation and establishing the research alliance.
WHY: Helps improve assay sensitivity. Intentional “neutralization”
of patient expectations can reduce the placebo response.
HOW: Integrates seamlessly into the design of your clinical trial.
Staff training is conducted at the Investigator meeting, and staff
materials allow for automatic refresher training prior to each subject
training. Subject brochure can be reviewed during each study visit.
The Placebo Response Reduction
Program was developed in
trials across various indications
with many trials conducted in:
Placebo responses result in failed trials (illustration):
• Migraine
• Interstitial Cystitis
• Painful Diabetic Neuropathy
• Painful Lumbar Radiculopathy
...and has been implemented
in a large-scale clinical trial of
a Phase III Program on Knee
Osteoarthritis involving:
25 Sites
600 Subjects
Large responses to placebo
reduce differences between
drug and placebo, leading
to trial failure
232 Pond Street, Natick, MA 01760
(781) 444-9605 info@analgesicsolutions.com
Good pain reports from patients lead
to a smaller SD, making the response
to active drug statistically significantly
different from placebo (* = p < 0.05)
(even though patients in placebo
group had a response)
analgesicsolutions.com