Back to resultsNasal Carbon Dioxide (CO2)for the Treatment of Temporomandibular Disorders (TMD)Related Pain
Primary Purpose
Temporomandibular Disorders, Pain, Headaches
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nasal Carbon Dioxide
Air
Sponsored by
About this trial
This is an interventional treatment trial for Temporomandibular Disorders focused on measuring Temporomandibular Disorders, TMD, TMJ/TMD, Pain Management, Pain, Headaches
Eligibility 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"
Sites / Locations
- University of Washington, Department of Oral Medicine, Box 356370, Health Sciences Building
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Nasal Carbon Dioxide
Air
Outcomes
Primary Outcome Measures
Change in pain status from baseline over a 3 hour period
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00484029
Brief Title
Nasal Carbon Dioxide (CO2)for the Treatment of Temporomandibular Disorders (TMD)Related Pain
Official Title
A Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Nasal CO2 in the Symptomatic Treatment of Temporomandibular Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Capnia, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Disorders, Pain, Headaches
Keywords
Temporomandibular Disorders, TMD, TMJ/TMD, Pain Management, Pain, Headaches
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Nasal Carbon Dioxide
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Air
Intervention Type
Drug
Intervention Name(s)
Nasal Carbon Dioxide
Intervention Description
Nasal Carbon Dioxide
Intervention Type
Other
Intervention Name(s)
Air
Intervention Description
Air (Medical Grade)
Primary Outcome Measure Information:
Title
Change in pain status from baseline over a 3 hour period
Time Frame
within 3 hours of the first dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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"
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward L. Truelove, DDS, MSD
Organizational Affiliation
University of Washington School of Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington, Department of Oral Medicine, Box 356370, Health Sciences Building
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Nasal Carbon Dioxide (CO2)for the Treatment of Temporomandibular Disorders (TMD)Related Pain
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