NCT01363284

Brief Summary

The purpose of this study is to identify, prior to prescribing, which neuropathic pain patients will benefit from duloxetine more specific the investigators aims are to:

  • Verify whether presence of chronic pain alters the pain modulation mechanisms, such as DNIC (diffuse noxious inhibitory control) and TS (temporal summation).
  • Investigate whether anti-neuropathic medications such as duloxetine indeed change the pain modulation profile, and whether this profile change is associated with a reduction of clinical pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable diabetes

Timeline
Completed

Started Jun 2010

Typical duration for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2011

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 1, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

October 11, 2017

Status Verified

October 1, 2017

Enrollment Period

2.2 years

First QC Date

May 17, 2011

Last Update Submit

October 10, 2017

Conditions

DiabetesPainful Neuropathy

Outcome Measures

Primary Outcomes (1)

  • Prediction of duloxetine pain relief efficacy by pre-treatment extent of the CPM response

    Regression model will assess predictive value of baseline pre-treatment extent of the CPM response and pain relief efficacy of duloxetine treatment.

    2 year

Secondary Outcomes (1)

  • Treatment-related increase in CPM response

    2 years

Study Arms (1)

Duloxetine

EXPERIMENTAL

The first week of the treatment is the placebo treatment. The effect of placebo will be taken into consideration for further evaluation the duloxetine effect on clinical pain and descending pain inhibition capabilities.

Drug: Duloxetine

Interventions

DuloxetineDRUG

First week of placebo. then, initial dose of 30 mg/d will be given for one week, in order to minimize possible side effects and drop outs, and then a fixed dose of 60 mg/d will be given for additional 4 weeks

Also known as: SSNRI
Duloxetine

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed as having painful diabetic neuropathy.
  • Pain is experienced for more than 3 months.
  • Pain severity is ≥ 4 on a 0-10 scale (last month average).

You may not qualify if:

  • Patient already receiving duloxetine or another SNRI/SSRI.
  • Known hypersensitivity to duloxetine or any of the inactive ingredients.
  • Treatment with a monoamine oxidase inhibitor (MAOI) within 14 days of randomization or potential need to use an MAOI during the study or within 5 days of discontinuation of study drug.
  • Uncontrolled narrow-angle glaucoma
  • Because of the risk of serious ventricular arrhythmias and sudden death potentially associated with elevated plasma levels of thioridazine (Mellaril), Cymbalta and thioridazine should not be co-administered
  • Inability to perform psychophysical testing, due to language or perceptual barriers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Medical center

Haifa, Israel

Location

Related Publications (1)

  • Yarnitsky D, Granot M, Nahman-Averbuch H, Khamaisi M, Granovsky Y. Conditioned pain modulation predicts duloxetine efficacy in painful diabetic neuropathy. Pain. 2012 Jun;153(6):1193-1198. doi: 10.1016/j.pain.2012.02.021. Epub 2012 Apr 3.

    PMID: 22480803DERIVED

MeSH Terms

Conditions

Diabetes MellitusNeuropathy, Painful

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • David Yarnitsky, PhD

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Neurology Department

Study Record Dates

First Submitted

May 17, 2011

First Posted

June 1, 2011

Study Start

June 1, 2010

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

October 11, 2017

Record last verified: 2017-10

Locations

IL(1)