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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.

Study Description
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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).

Condition or disease Intervention/treatment Phase
Temporomandibular Disorders Pain Headaches Drug: Nasal Carbon Dioxide Other: Air Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Nasal CO2 in the Symptomatic Treatment of Temporomandibular Disorders
Study Start Date : February 2007
Actual Primary Completion Date : October 2008
Actual Study Completion Date : December 2008

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Nasal Carbon Dioxide
 Drug: Nasal Carbon Dioxide
Nasal Carbon Dioxide
Placebo Comparator: 2
Air
 Other: Air
Air (Medical Grade)


Outcome Measures
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Primary Outcome Measures :
  1. Change in pain status from baseline over a 3 hour period [ Time Frame: within 3 hours of the first dose ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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"
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00484029


Locations
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United States, Washington
University of Washington, Department of Oral Medicine, Box 356370, Health Sciences Building
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Capnia, Inc.
Investigators
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Principal Investigator: Edward L. Truelove, DDS, MSD University of Washington School of Dentistry
More Information
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Responsible Party: Kristen Yen- Associate Director, Clinical, Capnia, Inc.
ClinicalTrials.gov Identifier: NCT00484029    
Other Study ID Numbers: C301
First Posted: June 8, 2007    Key Record Dates
Last Update Posted: August 20, 2010
Last Verified: August 2010
Keywords provided by Capnia, Inc.:
Temporomandibular Disorders
TMD
TMJ/TMD
 Pain Management
Pain
Headaches
Additional relevant MeSH terms:
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Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Disease
Headache
Pathologic Processes
Pain
Neurologic Manifestations
Craniomandibular Disorders
 Mandibular Diseases
Jaw Diseases
Musculoskeletal Diseases
Joint Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes