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Measuring Placebo Effect by Elimination and Investigating Mechanism of Action

Placebo Effect Clinical Trial

Official title:
Measuring Placebo Effect by Elimination and Investigating Its Mechanism of Action

Clinical Trial Summary

We propose to measure the effect of placebo by elimination as well as by a "balanced placebo" design, determine its interaction with active drug, and explore whether placebo exerts part of its effect at the pharmacokinetics level.

Clinical Trial Description

Placebos have been in use for centuries in medical practice. However, there is continued controversy regarding their effectiveness and mechanisms of action.

The results of the study are expected to further our understanding of a widely used medical intervention, i.e., placebo, and of how to maximize its potential beneficial effect. It will also help assess the appropriateness of measuring the placebo effect by elimination, which has important ethical implications in relation to the design of randomized clinical trials.

Comparison: caffeine vs placebo. Dependent variables:4 hours area under the curve (AUC) of pharmacodynamics endpoints as well as pharmacokinetics endpoints in a subgroup. ;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00426010
Study type Interventional
Source King Faisal Specialist Hospital & Research Center
Contact
Status Completed
Phase N/A
Start date January 2007
Completion date February 2009
View Details
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