Nasal Carbon Dioxide (CO2)for the Treatment of Temporomandibular Disorders (TMD)Related Pain - Full Text View

Sponsored by:	Capnia, Inc.
Information provided by:	Capnia, Inc.
ClinicalTrials.gov Identifier:	NCT00484029

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 II

MedlinePlus related topics: Headache Temporomandibular Joint Dysfunction

Drug Information available for: Carbon dioxide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Nasal CO2 in the Symptomatic Treatment of Temporomandibular Disorders

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
Estimated Study Completion Date:	December 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Nasal Carbon Dioxide	Drug: Nasal Carbon Dioxide Nasal Carbon Dioxide
2: Placebo Comparator 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:	Capnia, Inc. ( Kristen Yen- Associate Director, Clinical )
Study ID Numbers:	C301
Study First Received:	June 7, 2007
Last Updated:	November 25, 2008
ClinicalTrials.gov Identifier:	NCT00484029 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Capnia, Inc.:

Temporomandibular Disorders
TMD
TMJ/TMD

Pain Management
Pain
Headaches

Study placed in the following topic categories:

Fibromyalgia
Myofascial Pain Syndromes
Joint Diseases
Pain
Signs and Symptoms
Temporomandibular Joint Disorders
Muscular Diseases

Temporomandibular Joint Dysfunction Syndrome
Musculoskeletal Diseases
Craniomandibular Disorders
Headache
Neurologic Manifestations
Stomatognathic Diseases

Additional relevant MeSH terms:

Mandibular Diseases
Disease
Myofascial Pain Syndromes
Joint Diseases
Nervous System Diseases
Jaw Diseases
Pain
Signs and Symptoms
Temporomandibular Joint Disorders

Muscular Diseases
Pathologic Processes
Temporomandibular Joint Dysfunction Syndrome
Musculoskeletal Diseases
Craniomandibular Disorders
Headache
Neurologic Manifestations
Stomatognathic Diseases

ClinicalTrials.gov processed this record on May 07, 2009