NCT00115102

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2004

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 20, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 21, 2005

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
Last Updated

June 20, 2006

Status Verified

June 1, 2006

First QC Date

June 20, 2005

Last Update Submit

June 15, 2006

Conditions

Odontalgia

Keywords

Atypical odontalgiacapsaicinpainneuropathic pain

Outcome Measures

Primary Outcomes (3)

  • Pain

  • Sensitivity to heat and cold

  • Sensitivity to mechanical stimuli

Interventions

fentanylDRUG
S-ketamineDRUG

Eligibility Criteria

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

You may qualify if:

  • Atypical odontalgia

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danish Pain Research Center

Aarhus, DK-8000, Denmark

Location

MeSH Terms

Conditions

ToothachePainNeuralgia

Interventions

FentanylEsketamine

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesFacial PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Troels Staehelin Jensen, MD, PhD, Dr.Sci

    Aarhus University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 20, 2005

First Posted

June 21, 2005

Study Start

March 1, 2004

Study Completion

October 1, 2005

Last Updated

June 20, 2006

Record last verified: 2006-06

Locations

DK(1)