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Report for Clinical Trial NCT01179828

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Linking Altered Central Pain Processing and Genetic Polymorphism to Drug Efficacy in Chronic Low Back Pain

Drug therapy in patients with chronic low back pain is a major challenge for physicians. One of the problems is the lacking knowledge in prediction of drug efficacy in a chosen patient. Usually one of the classes of pain medication is given to patients with a similar clinical picture, although different pain mechanisms may be responsible for this clinical picture. Another reason for variable drug efficacy are genetic polymorphisms, this may be the reason why an unique drug produces different responses (from a lacking analgesic effect up to excessive effect or side-effects. Quantitative sensory testing is a method that documents alterations in the pain perception system. Linking genetic polymorphisms to quantitative sensory testing may give us a tool for anticipation of drug efficacy.

NCT01179828 Low Back Pain
MeSH:Back Pain Low Back Pain
HPO:Back pain Low back pain

4 Interventions

Name: Oxycodone 15mg

Description: 15mg single administration p.o.
Type: Drug
Group Labels: 1


Name: Clobazam

Description: 20mg single administration p.o.
Type: Drug
Group Labels: 1


Name: Imipramine

Description: 75mg single administration p.o.
Type: Drug
Group Labels: 1


Name: Tolterodine

Description: 1 mg single administration p.o.
Type: Drug
Group Labels: 1


Primary Outcomes

Measure: Difference in NRS(pain scale) between measurement after and before drug administration

Time: 07/2012

Secondary Outcomes

Measure: Patients global impression of change scale after drug administration

Time: 07/2012

Measure: Pharmacogenetic variables(see before)

Time: 07/2012

Measure: Pharmacokinetics: measure of Imipramine and desipramine blood levels

Time: 07/2012

Measure: Reliability of repeated quantitative sensory testing in the same patient

Time: 12/2010

Purpose: Basic Science

Allocation: Randomized

Crossover Assignment

There is one SNP


1 A118G

Methods Quantitative sensory testing: Heat pain threshold and tolerance, Ice water testing with central modulation of nociceptive input (DNIC), electrical pain detection and temporal summation (skin probe), pressure algometry with pain detection and threshold Drugs investigated: Imipramine, Oxycodone, Clobazam Blood samples: pharmacogenetics: Cytochrome variants CYP2D6, CYP2C19, CYP3A4, COMT haplotypes, CGH-1 variants, A118G of mu opioid receptor gene variants pharmacokinetics: kinetics of imipramine and desipramine --- A118G ---

HPO Nodes