Fentanyl Transmucosal Lozenge |
Oralet |
Clinical Trial: Sensory Examination and Pharmacological Modulation of Oral Hyperexcitability in Patients with Atypical Odontalgia and Matched Healthy Controls
This study is currently recruiting patients.
|
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Odontalgia | Drug: fentanyl Drug: S-ketamine | Phase IV |
MedlinePlus related topics: Pain; Tooth Disorders
Study Type: Interventional
Study Design: Diagnostic, Randomized, Double-Blind, Placebo Control, Crossover Assignment
Further Study Details:
Primary Outcomes: Pain; Sensitivity to heat and cold; Sensitivity to mechanical stimuli
Study start: March 2004
Data entry closure: November 2005
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Accepts Healthy Volunteers
Criteria
Inclusion Criteria:
- Atypical odontalgia
Exclusion Criteria:
- BMI > 30
- Heart conditions
- Lung disease
- Diseases of the liver or kidneys
- Hypertension, untreated
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00115102
Lene Baad-Hansen, DDS +45 89424167 lbhansen@odont.au.dk
Denmark
Danish Pain Research Center, Aarhus, DK-8000, Denmark; Recruiting
Troels Jensen, MD, PhD, Dr.Sci
Lene Baad-Hansen, DDS, Principal Investigator
Gitte Juhl, MD, Sub-Investigator
Lene Baad-Hansen, DDS, Principal Investigator
Gitte Juhl, MD, Sub-Investigator
Study chairs or principal investigators
Troels Staehelin Jensen, MD, PhD, Dr.Sci, Study Chair, Aarhus University Hospital
More Information
Study ID Numbers: AO1
Record last reviewed: March 2004
Last Updated: June 30, 2005
Record first received: June 20, 2005
ClinicalTrials.gov Identifier: NCT00115102
Health Authority: Denmark: Danish Medicines Agency
ClinicalTrials.gov processed this record on 2005-07-05
Record last reviewed: March 2004
Last Updated: June 30, 2005
Record first received: June 20, 2005
ClinicalTrials.gov Identifier: NCT00115102
Health Authority: Denmark: Danish Medicines Agency
ClinicalTrials.gov processed this record on 2005-07-05
Resources
- Fentanyl Transmucosal Lozenge (Drug Digest)
- Oralet (Drug Digest)

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