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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00484029
• Other study ID #: C301
• Status: Completed
• Phase: Phase 2
• First received: June 7, 2007
• Last updated: August 18, 2010
• Start date: February 2007
• Est. completion date: December 2008

Study information

• Verified date: August 2010
• Source: Capnia, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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"

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Headaches
• Pain
• Temporomandibular Disorders
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Drug:
• Nasal Carbon Dioxide
Nasal Carbon Dioxide

Other:
• Air
Air (Medical Grade)

Locations

Country	Name	City	State
United States	University of Washington, Department of Oral Medicine, Box 356370, Health Sciences Building	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Capnia, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain status from baseline over a 3 hour period		within 3 hours of the first dose	Yes