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

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Capnia, Inc.

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"