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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Kristen Yen- Associate Director, Clinical, Capnia, Inc.
ClinicalTrials.gov Identifier:	NCT00484029 History of Changes
Other Study ID Numbers:	C301
First Posted:	June 8, 2007
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:

Disease; Headache; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Pathologic Processes; 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