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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-000106-31-GB

Enrollment

200

Registered

2005-02-24

Start date

2005-03-15

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

OSTEOPOROSIS

Interventions

Product Name: TRAMADOL Pharmaceutical Form: INN or Proposed INN: As smpC

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: Inability to give informed consent.

Design outcomes

Primary

Measure	Time frame
Main Objective: To establish whether genetic variation in pharmacokinetic and pharmacodynamic pathways interacting with tramadol leads to variation in response to tramadol. ; Secondary Objective: The specific aims include: (1) To characterize the pharmacokinetics of tramadol metabolism in patients on long term tramadol therapy (2) To compare pharmacokinetic parameters between extensive and poor metaboliser of CYP2D6. (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. ;Primary end point(s): The primary endpoint is the tramadol AUC established via a population pk model	—

Measure

Time frame

Main Objective: To establish whether genetic variation in pharmacokinetic and pharmacodynamic pathways interacting with tramadol leads to variation in response to tramadol. ; Secondary Objective: The specific aims include: (1) To characterize the pharmacokinetics of tramadol metabolism in patients on long term tramadol therapy (2) To compare pharmacokinetic parameters between extensive and poor metaboliser of CYP2D6. (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. ;Primary end point(s): The primary endpoint is the tramadol AUC established via a population pk model

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026