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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Nasal CO2 in the Symptomatic Treatment of Temporomandibular Disorders

Conditions
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Pain, Temporomandibular Disorders, Headaches

Intervention / Treatment
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* Drug: Nasal Carbon Dioxide
* Other: Air


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Nasal Carbon Dioxide | Drug: Nasal Carbon Dioxide<br>* Nasal Carbon Dioxide<br>|
| Placebo Comparator: 2<br>Air | Other: Air<br>* Air (Medical Grade)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain status from baseline over a 3 hour period |  | within 3 hours of the first dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Temporomandibular Disorders, TMD, TMJ/TMD, Pain Management, Headaches