Effect of Duloxetine and Venlafaxine on the Pharmacokinetics and Pharmacodynamics of Oral Tramadol: A Three-phase Randomized Balanced Cross-over Study in Healthy Volunteers
|ClinicalTrials.gov Identifier: NCT01443520|
Recruitment Status : Completed
First Posted : September 29, 2011
Last Update Posted : May 22, 2012
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Placebo Drug: Duloxetine Drug: Venlafaxine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Crossover Assignment|
|Primary Purpose:||Basic Science|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||January 2012|
|Placebo Comparator: Placebo||
The subjects will be given orally placebo twice a day for 8 days prior to the study.
|Active Comparator: Duloxetine||
The subjects will be given orally duloxetine 30mg twice a day for 8 days prior to the study.
|Active Comparator: Venlafaxine||
The subjects will be given orally venlafaxine 37,5mg twice a day for 8 days prior to the study.
- Concentration of tramadol and its metabolites in plasma [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours after administration of tramadol ]
- Serotonin concentrations [ Time Frame: 0, 4 and 8 hours after tramadol administration ]Serotonin concentrations will be analyzed with chromatographical methods from the blood samples drawn 0, 4 and 8 hours after tramadol administration
- Pharmacodynamic effects [ Time Frame: 1, 2, 3, 4, 5, 6, 8, 10, 12 hours after administration of tramadol ]The psychomotor effects of tramadol will be assessed with the measurement of pupil size with Cogan's pupillometer, Maddox wing test and digit symbol substitution test
- Analgesia [ Time Frame: 1, 2, 3, 4, 5, 6, 8, 10, 12 hours after the administration of tramadol ]The analgesic effect of tramadol will be evaluated using the cold pressor test. Briefly, the subject's hand is immersed into ice-cold water of + 4° C up to the wrist. The subject is told to keep his or her hand in the water and to report when the cold sensation becomes painful. Cold pain threshold is defined as the latency from the immersion of the hand to the subject's first report of pain. Cold pain intensity is assessed at 30 s intervals following immersion of the hand in cold water for up to 60s . A verbal numerical rating scale of 0-100 will be used.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01443520
|Department of Anaesthesiology, Intensive Care, Emergency Care and Pain Medicine, Turku University and Turku University Hospital|