|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT02256956 |
|
Date of registration:
|
29/09/2014 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Genetic Determinants of Amitriptyline Efficiency for Pain Treatment - Part II
|
|
Scientific title:
|
Effects of Amitriptyline on Central Pain Processing in Healthy Volunteers Depending on CYP Pharmacogenetics |
|
Date of first enrolment:
|
November 2014 |
|
Target sample size:
|
48 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02256956 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
|
|
Phase:
|
Phase 4
|
|
|
Countries of recruitment
|
|
Switzerland
| | | | | | | |
|
Contacts
|
|
Name:
|
Pascal H Vuilleumier, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Bern University Hospital |
|
|
Name:
|
Ulrike Stamer, Professor |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Bern University Hospital |
| |
|
Key inclusion & exclusion criteria
|
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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Male
|
|
Health Condition(s) or Problem(s) studied
|
|
Chronic Pain
|
|
Intervention(s)
|
|
Drug: Amitriptyline
|
|
Drug: Tolterodine
|
|
Primary Outcome(s)
|
|
Nociceptive withdrawal reflex
[Time Frame: During measurement, expected to be ca. 2-3 minutes]
|
|
Secondary Outcome(s)
|
|
Pharmacogenetic information on CYP2D6 metabolism
[Time Frame: At baseline, i.e. on day 1]
|
|
Changes in plasmatic metabolite level
[Time Frame: Throughout study duration, expected to be ca. 20 days]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|