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

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: NCT00484029
Recruitment Status : Completed
First Posted : June 8, 2007
Last Update Posted : August 20, 2010
Sponsor:
Information provided by:
Capnia, Inc.

Tracking Information
First Submitted Date  ICMJE June 7, 2007
First Posted Date  ICMJE June 8, 2007
Last Update Posted Date August 20, 2010
Study Start Date  ICMJE February 2007
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2007)
Change in pain status from baseline over a 3 hour period [ Time Frame: within 3 hours of the first dose ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00484029 on ClinicalTrials.gov Archive Site
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 Nasal Carbon Dioxide (CO2)for the Treatment of Temporomandibular Disorders (TMD)Related Pain
Official Title  ICMJE A Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Nasal CO2 in the Symptomatic Treatment of Temporomandibular Disorders
Brief Summary 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).
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Temporomandibular Disorders
  • Pain
  • Headaches
Intervention  ICMJE
  • Drug: Nasal Carbon Dioxide
    Nasal Carbon Dioxide
  • Other: Air
    Air (Medical Grade)
Study Arms  ICMJE
  • Experimental: 1
    Nasal Carbon Dioxide
    Intervention: Drug: Nasal Carbon Dioxide
  • Placebo Comparator: 2
    Air
    Intervention: Other: Air
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
Actual Enrollment  ICMJE
 (submitted: November 25, 2008)
100
Original Estimated Enrollment  ICMJE
 (submitted: June 7, 2007)
115
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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"
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00484029
Other Study ID Numbers  ICMJE C301
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kristen Yen- Associate Director, Clinical, Capnia, Inc.
Study Sponsor  ICMJE Capnia, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Edward L. Truelove, DDS, MSD University of Washington School of Dentistry
PRS Account Capnia, Inc.
Verification Date August 2010

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