Sensory Examination and Pharmacological Modulation of Ora... | NCT00115102

Studies
Sensory Examination and Pharmacological Modulation of Oral Hyperexcitability in Patients With Atypical Odontalgia and Matched Healthy Controls

NCT00115102

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Jun 20, 2006Estimated

Enrollment

Phase

Phase 4

Conditions

Odontalgia

Interventions

fentanyl
S-ketamine

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2004

Primary Completion Date

Not provided

Completion Date

Oct 2005

First Submitted Date

Jun 20, 2005

First Submission Date that Met QC Criteria

Jun 20, 2005

First Posted Date

Jun 21, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 15, 2006

Last Update Posted Date

Jun 20, 2006Estimated

Name	Class
Danish Pain Research Center	OTHER

Description Module

Brief Summary

This project examines experimental pain and chronic pain in the mouth, specifically the condition called atypical odontalgia (AO:atypical toothpain). In 16 patients with AO and 16 healthy persons, capsaicin (chili-pepper) is applied to the gingiva to cause pain. This pain is evaluated by the participants. In three sessions, 3 different medications are tested for effect on the pain. The medications are fentanyl, S-ketamine and placebo-treatment (saline). The aim is to know more about pain mechanisms in AO in order to develop an effective treatment.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain
Sensitivity to heat and cold
Sensitivity to mechanical stimuli

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Atypical odontalgia

Exclusion Criteria:

BMI > 30
Heart conditions
Lung disease
Diseases of the liver or kidneys
Hypertension, untreated

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Troels Staehelin Jensen, MD, PhD, Dr.Sci	Aarhus University Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Danish Pain Research Center		Aarhus		DK-8000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D014098	Toothache
D010146	Pain
D009437	Neuralgia

Ancestor Terms

ID	Term
D014076	Tooth Diseases
D009057	Stomatognathic Diseases
D005157	Facial Pain
D009461	Neurologic Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005283	Fentanyl
C000629870	Esketamine

Ancestor Terms

ID	Term
D010880	Piperidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
fentanyl	Drug
S-ketamine	Drug