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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
History of Changes
  Purpose

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 Intervention Phase
Temporomandibular Disorders
Pain
Headaches
 Drug: Nasal Carbon Dioxide
Other: Air
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Capnia, Inc.:

Primary Outcome Measures:
  • 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 ]

Enrollment: 100
Study Start Date: February 2007
Study Completion Date: December 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Nasal Carbon Dioxide
 Drug: Nasal Carbon Dioxide
Nasal Carbon Dioxide
Placebo Comparator: 2
Air
 Other: Air
Air (Medical Grade)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00484029

Locations
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
Principal Investigator: Edward L. Truelove, DDS, MSD University of Washington School of Dentistry
  More Information

No publications provided

Responsible Party: Kristen Yen- Associate Director, Clinical, Capnia, Inc.
ClinicalTrials.gov Identifier: NCT00484029     History of Changes
Other Study ID Numbers: C301
Study First Received: June 7, 2007
Last Updated: August 18, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Capnia, Inc.:
Temporomandibular Disorders
TMD
TMJ/TMD
 Pain Management
Pain
Headaches

Additional relevant MeSH terms:
Headache
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Craniomandibular Disorders
 Mandibular Diseases
Jaw Diseases
Musculoskeletal Diseases
Joint Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes

ClinicalTrials.gov processed this record on May 23, 2013