Status:

COMPLETED

The Placebo Effect May Involve Modulating Drug Bioavailability

Lead Sponsor:

King Faisal Specialist Hospital & Research Center

Conditions:

Placebo Effect

Drug Half Life

Eligibility:

All Genders

18-60 years

Phase:

NA

Brief Summary

The total effect of a medication is the sum of its drug effect, placebo effect (meaning response of placebo), and their interaction. Current interpretation of clinical trials (the gold standard of evi...

Detailed Description

The total effect of a medication is the sum of its drug effect, placebo effect (meaning response of placebo), and their interaction. Current interpretation of clinical trials (the gold standard of evi...

Eligibility Criteria

Inclusion

  • Having no evidence of clinically important deviation from normal health as indicated by medical history, vital signs, and clinical laboratory tests.
  • Acceptance to abstain from taking any medication other than birth control pills (including over-the-counter drugs) for at least 1 week prior to, and during the study; and from smoking and taking alcohol or caffeine or related xanthenes-containing beverages or food for 48 hours before and throughout each study period.
  • Having good peripheral venous access.
  • For the caffeine study, habitual daily caffeine intake should be 100-300 mg.

Exclusion

  • Women should be non-pregnant and non-lactating. For menstruating women, the study will be conducted 5 to 19 days after the last menstrual period and a urine pregnancy test will be performed.
  • Should not have history of hypersensitivity to the drug to be tested or to its related compounds.
  • Body Mass Index (BMI) should be less than 35 kg/m2.

Key Trial Info

Start Date :

February 1 2012

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 1 2013

Estimated Enrollment :

162 Patients enrolled

Trial Details

Trial ID

NCT01501747

Start Date

February 1 2012

End Date

February 1 2013

Last Update

April 9 2013

Active Locations (1)

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1

King Faisal Specialist Hospital & Research Center

Riyadh, Saudi Arabia, 11211