Temporomandibular DisordersPhase 2NCT00484029
Nasal Carbon Dioxide (CO2)for the Treatment of Temporomandibular Disorders (TMD)Related Pain
A Phase 2 study testing Nasal Carbon Dioxide and Air in people with Temporomandibular Disorders and Pain, run by Capnia, Inc. at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Temporomandibular Disorders, Pain, Headaches
- What is being tested?
- Nasal Carbon Dioxide and Air
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Dec 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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"
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington, Department of Oral Medicine, Box 356370, Health Sciences Building
Seattle, Washington, 98195
About this study
Official title: A Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Nasal CO2 in the Symptomatic Treatment of Temporomandibular Disorders
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).
Read the 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.
- Conditions
- Temporomandibular Disorders, Pain, Headaches
- Being tested
- Nasal Carbon Dioxide, Air
- Keywords
- Temporomandibular Disorders, TMD, TMJ/TMD, Pain Management, Pain, Headaches
- Medical subject headings
- Temporomandibular Joint Disorders, Pain, Headache, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal Carbon DioxideDrug
Nasal Carbon Dioxide
AirOther
Air (Medical Grade)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Nasal Carbon Dioxide Receives: Drug: Nasal Carbon Dioxide |
| 2 | Placebo comparator | Air Receives: Other: Air |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain status from baseline over a 3 hour period
Measured: within 3 hours of the first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2007 (estimated)
- Study startFeb 2007
- Primary completionOct 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capnia, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Edward L. Truelove, DDS, MSD, Principal investigator, University of Washington School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00484029
- Sponsor's protocol ID
- C301
- Status last verified
- Aug 2010
- First submitted
- 7 Jun 2007
- Last updated
- 20 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Nasal CO2 in the Symptomatic Treatment of Temporomandibular Disorders
- ClinicalTrials.gov ID
- NCT00484029
- Acronym / sponsor ID
- C301
- Conditions
- Temporomandibular Disorders, Pain, Headaches
- Keywords
- Temporomandibular Disorders, TMD, TMJ/TMD, Pain Management, Pain, Headaches
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Capnia, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 8 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Nasal Carbon DioxideNasal Carbon Dioxide |
| 2 | Placebo comparator | Other: AirAir |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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 (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasal Carbon DioxideNasal Carbon Dioxide | Drug | 1 |
| AirAir (Medical Grade) | Other | 2 |
Primary outcome
Change in pain status from baseline over a 3 hour period
Time frame: within 3 hours of the first dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2010.
Related trials for Temporomandibular Disorders
Recruiting
Photobiomodulation for Management of Temporomandibular Disorder Pain
Pain Related to TMD
Recruiting
Effects of Vagus Nerve Stimulation on Temporomandibular Disorders.
TMD, Temporomandibular Disorders (TMDs)
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Not yet recruiting
Comparing Dextrose Prolotherapy vs. Sodium Hyaluronic Acid Injections for Jaw Joint Internal Derangement
Temporomandibular Joint Internal Derangement, TMJ-ID
Recruiting
R01_Pilot Jaw Muscle Phenotypes
Chronic TMD Pain, Temporomandibular Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward L. Truelove, DDS, MSD principal investigator
University of Washington School of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nasal Carbon Dioxide and Air in people with Temporomandibular Disorders and Pain, run by Capnia, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain status from baseline over a 3 hour period (time frame: within 3 hours of the first dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2010.