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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00115102
Recruitment Status : Completed
First Posted : June 21, 2005
Last Update Posted : June 20, 2006
Sponsor:
Collaborator:
Danish Pain Research Center
Information provided by:
University of Aarhus

Tracking Information
First Submitted Date  ICMJE June 20, 2005
First Posted Date  ICMJE June 21, 2005
Last Update Posted Date June 20, 2006
Study Start Date  ICMJE March 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
  • Pain
  • Sensitivity to heat and cold
  • Sensitivity to mechanical stimuli
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sensory Examination and Pharmacological Modulation of Oral Hyperexcitability in Patients With Atypical Odontalgia and Matched Healthy Controls
Official Title  ICMJE Not Provided
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Diagnostic
Condition  ICMJE Odontalgia
Intervention  ICMJE
  • Drug: fentanyl
  • Drug: S-ketamine
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June 15, 2006)
20
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE October 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Atypical odontalgia

Exclusion Criteria:

  • BMI > 30
  • Heart conditions
  • Lung disease
  • Diseases of the liver or kidneys
  • Hypertension, untreated
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00115102
Other Study ID Numbers  ICMJE AO1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Aarhus
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Danish Pain Research Center
Investigators  ICMJE
Study Chair: Troels Staehelin Jensen, MD, PhD, Dr.Sci Aarhus University Hospital
PRS Account University of Aarhus
Verification Date June 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP