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Genetic Determinants of Amitriptyline Efficiency for Pain Treatment - Part II

NCT02256956 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2019-01-24

No results posted yet for this study

Summary

Low dose tricyclic antidepressant drugs are routinely administered co-analgesics in pain medicine. Amitriptyline is largely considered as a gold standard. Amitriptyline underlies cytochrome CYP2D6 and CYP2D19 metabolism. CYP2D6 is highly polymorphic; numerous genetic variants result in 4 major classes characterizing enzymatic activity: poor metabolizers, intermediate metabolizers, extensive metabolizers and ultrarapid metabolizers. It is not known to which extent metabolizer classes determine pain outcomes or side-effects. As only one in three pain patients is considered to be a responder to amitriptyline's co-analgesic effect, prediction of treatment efficacy with a fast and easy to perform bedside test may contribute to the patients quality of life. The aim of this study is to determine the influence of cytochrome variants on experimental pain, drug related side-effects and finally identification of active metabolites.

Conditions

Interventions

DRUG

Amitriptyline

25 mg / day for 10 days

DRUG

Tolterodine

Placebo 1 mg / day for 10 days

Sponsors & Collaborators

  • University of Washington

    collaborator OTHER

  • Aalborg University

    collaborator OTHER

  • Ludwig-Maximilians - University of Munich

    collaborator OTHER

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Ulrike Stamer, Professor · Bern University Hospital

  • Pascal H Vuilleumier, MD · Bern University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2018-05-31
Completion
2019-01-31

Countries

  • Switzerland

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02256956 on ClinicalTrials.gov