CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 150 enrolled
Drug / intervention
Oxycodone 15mg +3 moredrug
Likely dose
Oxycodone 15mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01179828
NCT01179828Phase 3Completed

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

Insel Gruppe AG, University Hospital Bern·interventional·Posted Aug 11, 2010·Updated Apr 6, 2016

In Brief

A Phase 3 clinical trial evaluating Oxycodone 15mg, Clobazam, and 2 other interventions for Low Back Pain. Completed, enrolled 150 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLow Back Pain
CountriesSwitzerland

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 11, 2010
Enrollment StartJul 1, 2010
Primary CompletionApr 1, 2015
Study CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 15.9 years ago

Interventions

Oxycodone 15mgdrug

15mg single administration p.o.

Clobazamdrug

20mg single administration p.o.

Imipraminedrug

75mg single administration p.o.

Tolterodinedrug

1 mg single administration p.o.