Nasal Carbon Dioxide (CO2)for the Treatment of Temporomandibular Disorders (TMD)Related Pain
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| ClinicalTrials.gov Identifier: NCT00484029 |
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Recruitment Status :
Completed
First Posted : June 8, 2007
Last Update Posted : August 20, 2010
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Sponsor:
Capnia, Inc.
Information provided by:
Capnia, Inc.
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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 |
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 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 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Temporomandibular Joint Dysfunction
Drug Information available for:
Carbon dioxide
| Arm | Intervention/treatment |
|---|---|
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Experimental: 1
Nasal Carbon Dioxide
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Drug: Nasal Carbon Dioxide
Nasal Carbon Dioxide |
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Placebo Comparator: 2
Air
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Other: Air
Air (Medical Grade) |
Primary Outcome Measures :
- Change in pain status from baseline over a 3 hour period [ Time Frame: within 3 hours of the first dose ]
Information from the National Library of Medicine
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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 |
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"
Information from the National Library of Medicine
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
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 |
| 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 Key Record Dates |
| Last Update Posted: | August 20, 2010 |
| Last Verified: | August 2010 |
Keywords provided by Capnia, Inc.:
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Temporomandibular Disorders TMD TMJ/TMD |
Pain Management Pain Headaches |
Additional relevant MeSH terms:
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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 |