Pharmacokinetics Clinical Trial
Official title:
The Placebo Effect May Involve Modulating Drug Bioavailability
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 evidence-based-medicine) assumes no interaction, and the mechanism(s)
underlying such interaction have not been fully explored. One possibility is that the
placebo effect may modulate drug bioavailability. Using caffeine as a model drug, we have
recently shown that the placebo effect of caffeine ingestion prolongs caffeine half life.
Due to the novelty of this finding and its important clinical practice and clinical research
implications, it needs to be confirmed in another set of subjects and extended to additional
drugs.
The results of the study are expected to further our understanding of the mechanism of
action of a widely used medical intervention, i.e., placebo. The results will be important
for both clinical practice and clinical research.
Status | Completed |
Enrollment | 162 |
Est. completion date | February 2013 |
Est. primary completion date | February 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Country | Name | City | State |
---|---|---|---|
Saudi Arabia | King Faisal Specialist Hospital & Research Center | Riyadh |
Lead Sponsor | Collaborator |
---|---|
King Faisal Specialist Hospital & Research Center |
Saudi Arabia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Plasma half life | The study has 4 sub-parts (one for eah of 4 drugs), each sub-part has a crossover design. The time frame to measure the outcome depends on the drug studied. For caffeine it is 24 hours, for paracetamol, it is 14 hours, for cephalexin, it is 6 hours, and for ibuprofen, it is 10 hours. | 24 hours | No |
Secondary | Area under the curve | The study has 4 sub-parts (one for eah of 4 drugs), each sub-part has a crossover design. The time frame to measure the outcome depends on the drug studied. For caffeine it is 24 hours, for paracetamol, it is 14 hours, for cephalexin, it is 6 hours, and for ibuprofen, it is 10 hours. | 24 hours | No |
Secondary | Tmax | The study has 4 sub-parts (one for eah of 4 drugs), each sub-part has a crossover design. The time frame to measure the outcome depends on the drug studied. For caffeine it is 24 hours, for paracetamol, it is 14 hours, for cephalexin, it is 6 hours, and for ibuprofen, it is 10 hours. | 24 hours | No |
Secondary | Cmax | The study has 4 sub-parts (one for eah of 4 drugs), each sub-part has a crossover design. The time frame to measure the outcome depends on the drug studied. For caffeine it is 24 hours, for paracetamol, it is 14 hours, for cephalexin, it is 6 hours, and for ibuprofen, it is 10 hours. | 24 hours | No |
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