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

NCT01179828 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2016-04-06

No results posted yet for this study

Summary

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.

Conditions

  • Low Back Pain

Interventions

DRUG

Oxycodone 15mg

15mg single administration p.o.

DRUG

Clobazam

20mg single administration p.o.

DRUG

Imipramine

75mg single administration p.o.

DRUG

Tolterodine

1 mg single administration p.o.

Sponsors & Collaborators

  • University of Bern

    collaborator OTHER
  • University of Zurich

    collaborator OTHER
  • Aalborg University

    collaborator OTHER
  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Michele Curatolo, Prof · University Hospital Bern, Switzerland

  • Andreas Siegenthaler, Dr Med · University Hospital Bern, Switzerland

  • Pascal H Vuilleumier, Dr Med · University Hospital Bern, Switzerland

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2015-04-30
Completion
2015-12-31

Countries

  • Switzerland

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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 NCT01179828 on ClinicalTrials.gov