NCT00660751

Brief Summary

The role of central serotonergic and adrenergic systems in the effectiveness of DNIC (Diffuse Noxious Inhibitory Control) will be tested before and after taking Duloxetine and Placebo in a double blind study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Aug 2007

Longer than P75 for not_applicable healthy

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

August 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 17, 2008

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

October 11, 2017

Status Verified

October 1, 2017

Enrollment Period

4.7 years

First QC Date

April 15, 2008

Last Update Submit

October 10, 2017

Conditions

Healthy

Keywords

Physiology of Serotonergic and Adrenergic systems

Outcome Measures

Primary Outcomes (1)

  • level of DNIC

    1 week

Study Arms (2)

1

ACTIVE COMPARATOR
Drug: Duloxetine

2

PLACEBO COMPARATOR
Drug: Duloxetine

Interventions

DuloxetineDRUG

SNRIs

12

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteers
  • age 18-80
  • no chronic disease

You may not qualify if:

  • Subjects who suffer from chronic pain / pain syndrome
  • use of anti-depressant or anti-psychotic drugs
  • food/ drugs sensitivity
  • breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Health Care Campus

Haifa, 31096, Israel

Location

MeSH Terms

Interventions

Duloxetine Hydrochloride

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Prof. David Yarnitsky

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Neurology Department

Study Record Dates

First Submitted

April 15, 2008

First Posted

April 17, 2008

Study Start

August 1, 2007

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

October 11, 2017

Record last verified: 2017-10

Locations

IL(1)