Nasal Carbon Dioxide (CO2)for the Treatment of Temporomandibular Disorders (TMD)Related Pain

This study has been completed.
Sponsor:
Information provided by:
Capnia, Inc.
ClinicalTrials.gov Identifier:
NCT00484029
First received: June 7, 2007
Last updated: August 18, 2010
Last verified: August 2010

June 7, 2007
August 18, 2010
February 2007
October 2008   (final data collection date for primary outcome measure)
Change in pain status from baseline over a 3 hour period [ Time Frame: within 3 hours of the first dose ] [ Designated as safety issue: Yes ]
Change in pain status from baseline over a 3 hour period [ Time Frame: within 3 hours of the first dose ]
Complete list of historical versions of study NCT00484029 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Nasal Carbon Dioxide (CO2)for the Treatment of Temporomandibular Disorders (TMD)Related Pain
A Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Nasal CO2 in the Symptomatic Treatment of Temporomandibular Disorders

This purpose of this study is to evaluate the safety and efficacy of treatment with nasal CO2 in the treatment of pain and other symptoms related to temporomandibular disorder (TMD).

This is a randomized, controlled trial evaluating the safety and efficacy of nasal carbon dioxide for the treatment of pain and other symptoms related to temporomandibular disorders (TMD). Approximately 115 men and women ages 18 to 70 years old who have a history consistent with TMD-related pain for at least 3 months and meet all other eligibility criteria will be enrolled in this study. There may be up to two (2) visits to the clinic, screening and treatment. Screening and treatment may occur on the same day.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Temporomandibular Disorders
  • Pain
  • Headaches
  • Drug: Nasal Carbon Dioxide
    Nasal Carbon Dioxide
  • Other: Air
    Air (Medical Grade)
  • Experimental: 1
    Nasal Carbon Dioxide
    Intervention: Drug: Nasal Carbon Dioxide
  • Placebo Comparator: 2
    Air
    Intervention: Other: Air
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
December 2008
October 2008   (final data collection date for primary outcome measure)

Key Inclusion Criteria:

  • Have a history consistent with TMD-related pain for at least 3 months prior to screening
  • Agree not to use certain medications prior to randomization within the study specified
  • Females of childbearing potential must commit to using an acceptable method of birth control and have a negative pregnancy test.

Key Exclusion Criteria:

  • Have recent history of alcohol or drug abuse within 2 years prior to randomization
  • Current major psychiatric disorder such as suicidal ideation, bipolar, panic disorder, schizophrenic, or psychoses
  • History of asthma (other than mild or intermittent)
  • Have an existing serious unstable systemic disease (such as severe emphysema, other respiratory diseases, heart disease, etc.) that precludes participation in the study
  • Clinically significant nasal disorder (such as deviated septum, presence of polyps, evidence of significant congestion, rhinitis, or other nasal abnormalities)
  • Current diagnosis of fibromyalgia
  • History or clear clinical evidence of osteoarthritis of temporomandibular joint (TMJ)
  • A TMD diagnosis of disc displacement without reduction, "locking"
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00484029
C301
No
Kristen Yen- Associate Director, Clinical, Capnia, Inc.
Capnia, Inc.
Not Provided
Principal Investigator: Edward L. Truelove, DDS, MSD University of Washington School of Dentistry
Capnia, Inc.
August 2010

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