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

NCT00484029 | Completed Phase 2

• 1 other identifier: C301
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Temporomandibular Disorders; Pain; Headaches

Keywords

Temporomandibular Disorders; TMD; TMJ/TMD; Pain Management; Pain; Headaches

Outcome Measures

Primary Outcomes (1)

• Change in pain status from baseline over a 3 hour period

  within 3 hours of the first dose

Study Arms (2)

1

EXPERIMENTAL

Nasal Carbon Dioxide

Drug: Nasal Carbon Dioxide

2

PLACEBO COMPARATOR

Air

Other: Air

Interventions

Nasal Carbon Dioxide DRUG

Nasal Carbon Dioxide

1

Air OTHER

Air (Medical Grade)

2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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"

Sponsors & Collaborators

• Capnia, Inc.: lead

Study Sites (1)

University of Washington, Department of Oral Medicine, Box 356370, Health Sciences Building

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Pain; Headache; Agnosia

Interventions

Air

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health

Study Officials

• Edward L. Truelove, DDS, MSD

  University of Washington School of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 7, 2007
• First Posted: June 8, 2007
• Study Start: February 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: December 1, 2008
• Last Updated: August 20, 2010

Record last verified: 2010-08

Locations

US (1)