Nasal Carbon Dioxide (CO2)for the Treatment of Temporomandibular Disorders (TMD)Related Pain
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ClinicalTrials.gov Identifier: NCT00484029 |
Recruitment Status :
Completed
First Posted : June 8, 2007
Last Update Posted : August 20, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Temporomandibular Disorders Pain Headaches | Drug: Nasal Carbon Dioxide Other: Air | Phase 2 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Nasal Carbon Dioxide
|
Drug: Nasal Carbon Dioxide
Nasal Carbon Dioxide |
Placebo Comparator: 2
Air
|
Other: Air
Air (Medical Grade) |
- Change in pain status from baseline over a 3 hour period [ Time Frame: within 3 hours of the first dose ]

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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 |
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"

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
United States, Washington | |
University of Washington, Department of Oral Medicine, Box 356370, Health Sciences Building | |
Seattle, Washington, United States, 98195 |
Principal Investigator: | Edward L. Truelove, DDS, MSD | University of Washington School of Dentistry |
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 |
Temporomandibular Disorders TMD TMJ/TMD |
Pain Management Pain Headaches |
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 |