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Effects of Amitriptyline on Pain Processing in Healthy Volunteers
NCT02256943Phase 4
Key facts
- Status
- Completed
- Start
- Nov 2014
- Primary completion
- May 2018
- Countries
- 1
- Sponsor
- Insel Gruppe
- Modality
- Small Molecules
- Drugs
- amitriptyline
- Conditions
- chronic pain
01
Overview
Phase 4, randomised, double-blind trial of amitriptyline in chronic pain (2 arms), sponsored by Insel Gruppe. Primary endpoint: Nociceptive withdrawal reflex. Started Nov 2014; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Amitriptyline first, Placebo second
Sequence: Amitriptyline -> Washout -> Placebo
Placebo first, Amitriptyline second
Sequence: Placebo -> Washout -> Amitriptyline
03
Who it enrols
Healthy male volunteers with >7 Metabolic Equivalents. Excludes those with chronic pain, drug/alcohol abuse, neurologic dysfunction, ongoing antidepressant/analgesic treatment, or CYP3A inducer/inhibitor use.
04
Endpoints
Primary
Nociceptive withdrawal reflex
Secondary
Pharmacogenetic information on CYP2D6 metabolism
Changes in plasmatic metabolite level
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