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Trial record 6 of 135 for:    AMITRIPTYLINE

Genetic Determinants of Amitriptyline Efficiency for Pain Treatment - Part II

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02256956
Recruitment Status : Completed
First Posted : October 6, 2014
Last Update Posted : January 24, 2019
University of Washington
Aalborg University
Ludwig-Maximilians - University of Munich
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Pain Drug: Amitriptyline Drug: Tolterodine Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Amitriptyline on Central Pain Processing in Healthy Volunteers Depending on CYP Pharmacogenetics
Study Start Date : November 2014
Actual Primary Completion Date : May 2018
Actual Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Amitriptyline first, Placebo second
Amitriptyline first, Placebo second
Drug: Amitriptyline
25 mg / day for 10 days
Other Name: Tryptizol

Drug: Tolterodine
Placebo 1 mg / day for 10 days

Active Comparator: Placebo first, Amitriptyline second
Placebo first, Amitriptyline second
Drug: Amitriptyline
25 mg / day for 10 days
Other Name: Tryptizol

Drug: Tolterodine
Placebo 1 mg / day for 10 days

Primary Outcome Measures :
  1. Nociceptive withdrawal reflex [ Time Frame: During measurement, expected to be ca. 2-3 minutes ]
    Measure of involuntary electromyographic amplitude

Secondary Outcome Measures :
  1. Pharmacogenetic information on CYP2D6 metabolism [ Time Frame: At baseline, i.e. on day 1 ]
    Laboratory measurement (genotyping)

  2. Changes in plasmatic metabolite level [ Time Frame: Throughout study duration, expected to be ca. 20 days ]
    Metabolite level in plasma

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy
  • Male
  • >7 Metabolic Equivalents
  • Written informed consent

Exclusion Criteria

  • Chronic pain syndrome
  • Drug abuse
  • Alcohol abuse
  • Suspicion of neurologic dysfunction at tested sites
  • Ongoing treatment with antidepressants
  • Ongoing treatment with analgesics
  • Pretreatment with any CYP3A inducers or inhibitors
  • Known allergy to tested drugs
  • Elevated eye pressure
  • Obstructive uropathy
  • Heart disease
  • Pulmonary disease
  • Neurological disease
  • Psychiatric illness

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02256956

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Dep. of Anesthesiology, Bern University Hospital
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
University of Washington
Aalborg University
Ludwig-Maximilians - University of Munich
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Study Chair: Ulrike Stamer, Professor Bern University Hospital
Principal Investigator: Pascal H Vuilleumier, MD Bern University Hospital

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Responsible Party: University Hospital Inselspital, Berne Identifier: NCT02256956     History of Changes
Other Study ID Numbers: 133/12_2
First Posted: October 6, 2014    Key Record Dates
Last Update Posted: January 24, 2019
Last Verified: January 2019
Keywords provided by University Hospital Inselspital, Berne:
Pharmacogenetics of Amitriptyline
Additional relevant MeSH terms:
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Amitriptyline, perphenazine drug combination
Chronic Pain
Neurologic Manifestations
Signs and Symptoms
Tolterodine Tartrate
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Adrenergic Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants