IMPACT OF CYP2D6, SEROTONIN TRANSPORTER, 5HT1, 5HT2 AND 5HT3 RECEPTOR AND MU RECEPTOR GENE POLYMORPHISMS ON EFFICACY AND TOXICITY OF TRAMADOL - Tramadol and Genetic variability
Phase 1
- Conditions
- OSTEOPOROSIS
- Registration Number
- EUCTR2005-000106-31-GB
- Lead Sponsor
- Royal Liverpool University Hospital Clinical Trials 4th floor Linda McCartney Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
Subject can give informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Inability to give informed consent.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To establish whether genetic variation in pharmacokinetic and pharmacodynamic pathways interacting with tramadol leads to variation in response to tramadol. ;<br> Secondary Objective: The specific aims include:<br> (1)To characterize the pharmacokinetics of tramadol metabolism in patients on long term tramadol therapy<br> (2)To compare pharmacokinetic parameters between extensive and poor metaboliser of CYP2D6.<br> (3)To establish if there is an association between analgesic response and polymorphisms in genes coding for the serotonin transporters and 5HT1, 5HT2, 5HT3 receptors and the mu opioid receptor.<br> ;Primary end point(s): The primary endpoint is the tramadol AUC established via a population pk model
- Secondary Outcome Measures
Name Time Method