Duloxetine for Treatment of Painful Temporomandibular Joint Disorder
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00981149|
Recruitment Status : Completed
First Posted : September 22, 2009
Results First Posted : November 1, 2017
Last Update Posted : April 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Temporomandibular Joint Disorders||Drug: duloxetine Drug: Placebo||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Duloxetine for Treatment of Painful Temporomandibular Joint Disorder|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||December 2011|
Experimental: duloxetine study drug
Evaluate the analgesic effect of 30 mg duloxetine twice daily in comparison to matching placebo at baseline (BL) and follow up over a six week period
Other Name: Cymbalta
Placebo Comparator: Placebo
Placebo match duloxetine for 6 week period.
- Spontaneous Pain as Measured by Visual Analog Scale at Baseline and at End of 6 Weeks. [ Time Frame: 1, 3, 6 weeks ]Measurements from zero to 100 with 100 being the worst pain by Visual Analog Scale (VAS).
- Evoked Pain Via Algometry . [ Time Frame: 6 weeks ]Assessment of evoked pain using digital palpation examination at 18 predefined bodily sites.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00981149
|United States, Maryland|
|University of Maryland Dental School|
|Baltimore, Maryland, United States, 21201|
|Principal Investigator:||Sharon M Gordon, DDS MPH, PhD||University of Maryland Dental School|