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Effect of Duloxetine and Venlafaxine on the Pharmacokinetics and Pharmacodynamics of Oral Tramadol: A Three-phase Randomized Balanced Cross-over Study in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Turku University Hospital
ClinicalTrials.gov Identifier:
NCT01443520
First received: September 28, 2011
Last updated: May 21, 2012
Last verified: May 2012

September 28, 2011
May 21, 2012
October 2011
January 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01443520 on ClinicalTrials.gov Archive Site
  • Serotonin concentrations [ Time Frame: 0, 4 and 8 hours after tramadol administration ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
Effect of Duloxetine and Venlafaxine on the Pharmacokinetics and Pharmacodynamics of Oral Tramadol: A Three-phase Randomized Balanced Cross-over Study in Healthy Volunteers
Not Provided

Tramadol is an opioid analgesic, which is widely used in the treatment of acute and neuropathic pain. After oral administration, tramadol is rapidly and almost completely absorbed. Tramadol is extensively metabolised by O- and N-demethylation, which are catalysed by the liver CYP-450 enzymes. O-desmethyltramadol is an active metabolite and its formation is catalysed by CYP2D6. This study is aimed to investigate the possible interaction of oral tramadol with duloxetine and venlafaxine. Duloxetine is known to inhibit CYP2D6. Twelve healthy male or female adult non-smoking volunteers aged 18-40 years with body weights within ±15% of the ideal weight for height are taken into the study. Primary endpoints of the study are plasma concentrations of tramadol and its metabolites.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Healthy
  • Drug: Placebo
    The subjects will be given orally placebo twice a day for 8 days prior to the study.
  • Drug: Duloxetine
    The subjects will be given orally duloxetine 30mg twice a day for 8 days prior to the study.
  • Drug: Venlafaxine
    The subjects will be given orally venlafaxine 37,5mg twice a day for 8 days prior to the study.
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Active Comparator: Duloxetine
    Intervention: Drug: Duloxetine
  • Active Comparator: Venlafaxine
    Intervention: Drug: Venlafaxine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
January 2012
January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy volunteers
  • Age 18-40
  • Body weight within ±15% of the ideal weight for height

Exclusion Criteria:

  • A previous history of intolerance to the study drugs or to related compounds and additives
  • Concomitant drug therapy of any kind for at least 14 days prior to the study
  • Existing or recent significant disease
  • History of hematological, endocrine, metabolic or gastrointestinal disease, including gut motility disorders
  • History of asthma or any kind of drug allergy
  • Previous or present alcoholism, drug abuse, psychological or other emotional problems that are likely to invalidate informed consent, or limit the ability of the subject to comply with the protocol requirements
  • A positive test result for urine toxicology
  • A "yes" answer to any one of the Abuse Questions
  • Pregnancy or nursing
  • Donation of blood for 4 weeks prior and during the study
  • Special diet or life style conditions which would compromise the conditions of the study or interpretation of the results
  • Participation in any other studies involving investigational or marketed drug products concomitantly or within one month prior to the entry into this study
  • Smoking for one month before the start of the study and during the whole study period
  • Any history of coagulation abnormality, also in first degree relatives
Both
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT01443520
97/180/2011, 2011-003259-20
Not Provided
Turku University Hospital
Turku University Hospital
Not Provided
Not Provided
Turku University Hospital
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP