- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01501747
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.
Study Overview
Status
Conditions
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 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.
DESIGN: Balanced cross-over, single-dose, two-period, two-group deign comparing caffeine, paracetamol, cephalexin, and ibuprofen described as such (overt) to the same medication described as placebo (covert).
METHODS: 32, 50, 50, and 30 healthy adult volunteers will be enrolled in the caffeine (300 mg), paracetamol (500 mg), cephalexin (500 mg), and ibuprofen (400 mg) cross-over studies, respectively. Volunteers will be partially deceived to the intervention assignment (i.e., in the covert arm). Serum levels of each drug will be blindly determined by locally validated HPLC assays. Plasma half life (primary outcome) as well as Cmax, Tmax, and AUC (secondary outcomes) of each drug will be determined and analyzed by ANOVA.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Riyadh, Saudi Arabia, 11211
- King Faisal Specialist Hospital & Research Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: overt drug
The study has 4 sub-parts (one for each of 4 drugs), each sub-part has a crossover design.
In this arm, the volunteer will be given one oral dose of 300 mg caffeine, 500 mg paracetamol, 500 mg cephalexin, or 400 mg ibuprofen and will be told that they are receiving such medication.
|
The study has 4 sub-parts (one for each of 4 drugs), each sub-part has a crossover design.
In this arm, the volunteer will be given one oral dose of 300 mg caffeine, 500 mg paracetamol, 500 mg cephalexin, or 400 mg ibuprofen and will be told that they are receiving the active drug.
|
Placebo Comparator: Placebo (Covert drug)
The study has 4 sub-parts (one for each of 4 drugs), each sub-part has a crossover design.
In this arm, the volunteer will be given one oral dose of 300 mg caffeine, 500 mg paracetamol, 500 mg cephalexin, or 400 mg ibuprofen and will be told that they are receiving a placebo.
|
The study has 4 sub-parts (one for each of 4 drugs), each sub-part has a crossover design.
In this arm, the volunteer will be given one oral dose of 300 mg caffeine, 500 mg paracetamol, 500 mg cephalexin, or 400 mg ibuprofen and will be told that they are receiving a placebo.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma half life
Time Frame: 24 hours
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area under the curve
Time Frame: 24 hours
|
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
|
Tmax
Time Frame: 24 hours
|
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
|
Cmax
Time Frame: 24 hours
|
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
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Antipyretics
- Purinergic Antagonists
- Purinergic Agents
- Anti-Bacterial Agents
- Phosphodiesterase Inhibitors
- Purinergic P1 Receptor Antagonists
- Central Nervous System Stimulants
- Acetaminophen
- Ibuprofen
- Cephalexin
- Caffeine
Other Study ID Numbers
- RAC2101105
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pharmacokinetics
-
Astellas Pharma Global Development, Inc.Basilea Pharmaceutica International LtdCompletedHealthy Subjects | Pharmacokinetics of Isavuconazole | Pharmacokinetics of Methotrexate | Pharmacokinetics of 7-hydroxymethotrexateUnited States
-
Astellas Pharma IncCompletedHealthy | Pharmacokinetics of ASP1941 | Pharmacokinetics of MitiglinideJapan
-
Astellas Pharma Global Development, Inc.Basilea Pharmaceutica International LtdCompletedHealthy Volunteers | Pharmacokinetics of Isavuconazole | Pharmacokinetics of MethadoneUnited States
-
Astellas Pharma IncBasilea PharmaceuticaCompletedHealthy Volunteers | Pharmacokinetics of Isavuconazole | Pharmacokinetics of MidazolamUnited States
-
Astellas Pharma Global Development, Inc.Basilea Pharmaceutica International LtdCompletedHealthy Volunteers | Pharmacokinetics of Isavuconazole | Pharmacokinetics of DigoxinUnited States
-
Astellas Pharma Global Development, Inc.Basilea Pharmaceutica International LtdCompletedHealthy Volunteers | Pharmacokinetics of Isavuconazole | Pharmacokinetics of BupropionUnited States
-
Astellas Pharma Global Development, Inc.Basilea Pharmaceutica International LtdCompletedHealthy Subjects | Pharmacokinetics of Isavuconazole | Pharmacokinetics of SirolimusUnited States
-
Astellas Pharma Global Development, Inc.Basilea Pharmaceutica International LtdCompletedHealthy Volunteers | Pharmacokinetics of Isavuconazole | Pharmacokinetics of AtorvastatinUnited States
-
Astellas Pharma Global Development, Inc.Basilea Pharmaceutica International LtdCompletedHealthy Subjects | Pharmacokinetics of Caffeine | Pharmacokinetics of RepaglinideUnited States
-
Astellas Pharma Global Development, Inc.Basilea Pharmaceutica International LtdCompletedHealthy Subjects | Pharmacokinetics of Isavuconazole | Pharmacokinetics of MetforminUnited States
Clinical Trials on Caffeine, paracetamol, cephalexin, or ibuprofen
-
Brett A FaineUniversity of California, Los AngelesNot yet recruitingPyelonephritis Acute
-
Indonesia UniversityCompleted
-
GlaxoSmithKlineTerminatedHeadache, Tension-TypeUnited States
-
Stanford UniversityWashington University School of Medicine; Duke University; University of Washington and other collaboratorsEnrolling by invitation
-
Ullevaal University HospitalUniversity of OsloCompleted
-
Reckitt Benckiser LLCPremier Research Group plc; Aptuit Inc.CompletedPost-operative PainUnited States
-
Boehringer IngelheimCompletedPain, Postoperative | Tooth DiseasesUnited States
-
Boehringer IngelheimCompleted
-
GlaxoSmithKlineCompleted
-
Ullevaal University HospitalUniversity of OsloCompleted