| Trial ID: | L3869 |
| Source ID: | NCT02246712
|
| Associated Drug: |
Single Oral Dose Of 100 Mg Racemic Tramadol
|
| Title: |
Influence of Diabetes on Tramadol Pharmacokinetics
|
| Acronym: |
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| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Neuropathic Pain|Type 1 Diabetes Mellitus|Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Single oral dose of 100 mg racemic tramadol|OTHER: CYP2D6 phenotype|OTHER: CYP3A phenotype|GENETIC: CYP2B6 genotype
|
| Outcome Measures: |
Primary: Kinetic parameters (AUC, Cmax, Tmax, apparent total clearance, and apparent volume of distribution) of tramadol enantiomers were estimated., Up to 24h after a single oral dose of tramadol (100 mg) | Secondary: Urinary concentration ratio (metoprolol/alfa-hydroxymetoprolol) as an in vivo measure of CYP2D6 activity, The CYP2D6 phenotype was determined by urinary concentration ratio metoprolol/alfa-hydroxymetoprolol, Up to 8h after metoprolol administration|Clearance of midazolam as a measure of CYP3A in vivo activity, Up to 6h after midazolam administration|Pain scores on the visual analog scale, Up to 24h after a single oral dose of tramadol (100 mg)
|
| Sponsor/Collaborators: |
Sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho | Collaborators: University of Sao Paulo
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
30
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2008-06
|
| Completion Date: |
2011-12
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| Results First Posted: |
|
| Last Update Posted: |
2014-09-23
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| Locations: |
Universidade Estadual Paulista Julio de Mesquita Filho, Araraquara, SP, 14801902, Brazil
|
| URL: |
https://clinicaltrials.gov/show/NCT02246712
|
