NCT01744964

Brief Summary

The aims of this study were to assess the effects of the dopamine agonist apomorphine on experimental pain models in healthy subjects and to explore the possible association between these effects and a common polymorphism within the dopamine transporter gene.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P75+ for early_phase_1 healthy

Timeline
Completed

Started Jul 2009

Longer than P75 for early_phase_1 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

July 1, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 6, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 7, 2012

Completed
Last Updated

September 16, 2016

Status Verified

September 1, 2016

Enrollment Period

2 years

First QC Date

December 6, 2012

Last Update Submit

September 15, 2016

Conditions

Healthy

Keywords

apomorphinedopamine transporter geneSLC6A3cold pressor testtoleranceexperimental paindopamine agonist

Outcome Measures

Primary Outcomes (1)

  • Cold pain tolerance

    120 minutes

Study Arms (2)

Saline

PLACEBO COMPARATOR

Assessment of experimental pain models before and after treatment

Drug: Apomorphine

Apomorphine

ACTIVE COMPARATOR

Assessment of experimental pain models before and after treatment

Drug: Apomorphine

Interventions

ApomorphineDRUG

1.5 mg Apomorphine

Also known as: Active Comparator: Apomorphine
ApomorphineSaline

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- healthy and free from chronic pain of any type did not use any medications other than oral contraceptives were able to understand the purpose and instructions of the study.

You may not qualify if:

  • \- any type of medical or painful condition use of medications or recreational drugs pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Health Care Campus

Haifa, Israel

Location

MeSH Terms

Interventions

Apomorphine

Intervention Hierarchy (Ancestors)

AporphinesBenzylisoquinolinesAlkaloidsHeterocyclic CompoundsIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 4 or More Rings

Study Officials

  • Elon Eisenberg, MD

    Rambam Health Care Campus, Haifa, Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2012

First Posted

December 7, 2012

Study Start

July 1, 2009

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

September 16, 2016

Record last verified: 2016-09

Locations

IL(1)