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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00426010 |
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Date of registration:
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23/01/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Measuring Placebo Effect by Elimination and Investigating Mechanism of Action
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Scientific title:
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Measuring Placebo Effect by Elimination and Investigating Its Mechanism of Action |
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Date of first enrolment:
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January 2007 |
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Target sample size:
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180 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00426010 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Saudi Arabia
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Contacts
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Name:
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Muhammad M Hammami, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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KFSH & RC, Riyadh |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Males and nonpregnant females 18 and 40 years of age with at least high school
education.
Exclusion criteria:
- Include evidence of clinically relevant deviation from normal health (such that it
may affect the endpoints, make the ingestion of caffeine dangerous, or affect the
pharmacokinetics/pharmacodynamics of caffeine),
- Pregnancy,
- Poor venous access,
- Hypertension (more than 140/90),
- Heart disease,
- History of panic attacks,
- Average daily caffeine consumption of more than 300 or less than 100 mg,
- Smoking,
- Alcohol abuse,
- Taking any medication other than birth control bills (including over-the-counter
drugs) within one week from starting the study,
- Hypersensitivity to caffeine or related compounds,
- Hemoglobin of less than 13 gm/L, and recent (one week) acute illness
Age minimum:
18 Years
Age maximum:
40 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Placebo Effect
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Placebo Mechanisms of Action
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Intervention(s)
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Drug: caffeine/placebo
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Primary Outcome(s)
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4 hours area under the curve (AUC) of nausea measured by Visual Analogue Scales.
[Time Frame: 4 hours]
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4 hours area under the curve (AUC) of energy level measured by Visual Analogue Scales.
[Time Frame: 4 hours]
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4 hours area under the curve (AUC) of peripheral systolic blood pressure
[Time Frame: 4 hours]
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4 hours area under the curve (AUC) of alertness level measured by Visual Analogue Scales.
[Time Frame: 4 hours]
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Secondary Outcome(s)
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t1/2 of serum caffeine (in a subgroup)
[Time Frame: 14 hours]
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Tmax of serum caffeine (in a subgroup)
[Time Frame: 4 hours]
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Cmax of serum caffeine (in a subgroup)
[Time Frame: 4 hours]
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AUC of serum caffeine (in a subgroup)
[Time Frame: 14 hours]
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Secondary ID(s)
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KACST:ARP-26-45
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RAC# 2051072
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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