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

NCT01179828 | Completed Phase 3 DMC

• 2 other identifiers: KEK 213/09grant: SPUM no. 33CM30_124117
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Quantitative sensory testing; Drug efficacy; Low back pain syndrome; Imipramine; Oxycodone; Clobazam; Tolterodine

Outcome Measures

Primary Outcomes (1)

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

  07/2012

Secondary Outcomes (4)

• Patients global impression of change scale after drug administration

  07/2012

• Pharmacogenetic variables(see before)

  07/2012

• Pharmacokinetics: measure of Imipramine and desipramine blood levels

  07/2012

• Reliability of repeated quantitative sensory testing in the same patient

  12/2010

Study Arms (4)

1

ACTIVE COMPARATOR

Oxycodone 15mg

Drug: Oxycodone 15mg

2

ACTIVE COMPARATOR

Clobazam 20mg

Drug: Clobazam

3

ACTIVE COMPARATOR

Imipramine 75mg

Drug: Imipramine

4

PLACEBO COMPARATOR

Tolterodine 1mg

Drug: Tolterodine

Interventions

Oxycodone 15mg DRUG

15mg single administration p.o.

1

Clobazam DRUG

20mg single administration p.o.

2

Imipramine DRUG

75mg single administration p.o.

3

Tolterodine DRUG

1 mg single administration p.o.

4

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Low back pain with NRS\>2
• Chronic low back pain since more than 6 months

You may not qualify if:

• pregnancy
• use of pain medication other than paracetamol and ibuprofen in the last 7 days
• suspicion of radicular pain
• suspicion of intervertebral disk herniation
• foraminal intervertebral stenosis
• suspicion of polyneuropathy
• diabetes
• parkinson disease
• alzheimer disease
• glaucoma
• prostata hyperplasia or voiding problems
• known heart rhythm problems
• heart insufficiency NYHA 3-4
• Systemic inflammatory disease
• Ongoing oncologic disease

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• University of Bern: collaborator
• University of Zurich: collaborator
• Aalborg University: collaborator

Study Sites (1)

Andreas Siegenthaler

Dep. of Anesthesiolgy and Pain Therapy, Bern University Hospital, 3010 Bern, Switzerland

Location

Related Publications (7)

• Saarto T, Wiffen PJ. Antidepressants for neuropathic pain. Cochrane Database Syst Rev. 2007 Oct 17;2007(4):CD005454. doi: 10.1002/14651858.CD005454.pub2.

  PMID: 17943857 BACKGROUND

• Arendt-Nielsen L, Yarnitsky D. Experimental and clinical applications of quantitative sensory testing applied to skin, muscles and viscera. J Pain. 2009 Jun;10(6):556-72. doi: 10.1016/j.jpain.2009.02.002. Epub 2009 Apr 19.

  PMID: 19380256 RESULT

• Foulkes T, Wood JN. Pain genes. PLoS Genet. 2008 Jul 25;4(7):e1000086. doi: 10.1371/journal.pgen.1000086.

  PMID: 18654615 RESULT

• Curatolo M, Arendt-Nielsen L, Petersen-Felix S. Central hypersensitivity in chronic pain: mechanisms and clinical implications. Phys Med Rehabil Clin N Am. 2006 May;17(2):287-302. doi: 10.1016/j.pmr.2005.12.010.

  PMID: 16616268 RESULT

• Markenson JA, Croft J, Zhang PG, Richards P. Treatment of persistent pain associated with osteoarthritis with controlled-release oxycodone tablets in a randomized controlled clinical trial. Clin J Pain. 2005 Nov-Dec;21(6):524-35. doi: 10.1097/01.ajp.0000146215.86038.38.

  PMID: 16215338 RESULT

• Schliessbach J, Siegenthaler A, Butikofer L, Vuilleumier P, Juni P, Arendt-Nielsen L, Curatolo M. Quantitative sensory tests fairly reflect immediate effects of oxycodone in chronic low-back pain. Scand J Pain. 2017 Oct;17:107-115. doi: 10.1016/j.sjpain.2017.07.004. Epub 2017 Aug 9.

  PMID: 28850362 DERIVED

• Siegenthaler A, Schliessbach J, Vuilleumier PH, Juni P, Zeilhofer HU, Arendt-Nielsen L, Curatolo M. Linking altered central pain processing and genetic polymorphism to drug efficacy in chronic low back pain. BMC Pharmacol Toxicol. 2015 Sep 16;16:23. doi: 10.1186/s40360-015-0023-z.

  PMID: 26376691 DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

Oxycodone; Clobazam; Imipramine; Tolterodine Tartrate

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Phenylpropanolamine; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Cresols; Phenols

Study Officials

• Michele Curatolo, Prof

  University Hospital Bern, Switzerland

  STUDY CHAIR

• Andreas Siegenthaler, Dr Med

  University Hospital Bern, Switzerland

  STUDY DIRECTOR

• Pascal H Vuilleumier, Dr Med

  University Hospital Bern, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 10, 2010
• First Posted: August 11, 2010
• Study Start: July 1, 2010
• Primary Completion: April 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 6, 2016

Record last verified: 2016-04

Locations

CH (1)