Trial Outcomes & Findings for Duloxetine for Treatment of Painful Temporomandibular Joint Disorder (NCT NCT00981149)

NCT ID: NCT00981149

Last Updated: 2021-05-25

Results Overview

Measurements from zero to 100 with 100 being the worst pain by Visual Analog Scale (VAS).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 24 participants
• Primary outcome timeframe: 1, 3, 6 weeks
• Results posted on: 2021-05-25

Participant Flow

Participant milestones

Measure	Duloxetine Study Drug Drug duloxetine: 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	Placebo Placebo Placebo: Placebo match duloxetine for 6 week period.
Overall Study STARTED	12	12
Overall Study COMPLETED	10	9
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Measure	Duloxetine Study Drug Drug duloxetine: 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	Placebo Placebo Placebo: Placebo match duloxetine for 6 week period.
Overall Study Lost to Follow-up	1	2
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

Duloxetine for Treatment of Painful Temporomandibular Joint Disorder

Baseline characteristics by cohort

Measure	Duloxetine Study Drug n=12 Participants Drug duloxetine: 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	Placebo n=12 Participants Placebo Placebo: Placebo match duloxetine for 6 week period.	Total n=24 Participants Total of all reporting groups
Age, Customized 18 to 65 years	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized White	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized Black	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1, 3, 6 weeks

Measurements from zero to 100 with 100 being the worst pain by Visual Analog Scale (VAS).

Outcome measures

Measure	Duloxetine Study Drug n=10 Participants Drug duloxetine: 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	Placebo n=9 Participants Placebo Placebo: Placebo match duloxetine for 6 week period.
Spontaneous Pain as Measured by Visual Analog Scale at Baseline and at End of 6 Weeks. 1 week	42.9 units on a scale Standard Deviation 14.5	51.4 units on a scale Standard Deviation 19
Spontaneous Pain as Measured by Visual Analog Scale at Baseline and at End of 6 Weeks. 3 weeks	30.4 units on a scale Standard Deviation 18	44 units on a scale Standard Deviation 25
Spontaneous Pain as Measured by Visual Analog Scale at Baseline and at End of 6 Weeks. 6 weeks	34.8 units on a scale Standard Deviation 23.7	36.7 units on a scale Standard Deviation 26

SECONDARY outcome

Timeframe: 6 weeks

Assessment of evoked pain using digital palpation examination at 18 predefined bodily sites.

Outcome measures

Measure	Duloxetine Study Drug n=12 Participants Drug duloxetine: 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	Placebo n=12 Participants Placebo Placebo: Placebo match duloxetine for 6 week period.
Evoked Pain Via Algometry .	311.9 Pain pressure threshold (kg/cm2) Standard Deviation 115.8	300.8 Pain pressure threshold (kg/cm2) Standard Deviation 80.9

Adverse Events

Duloxetine Study Drug

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Duloxetine Study Drug n=10 participants at risk Drug duloxetine: 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	Placebo n=9 participants at risk Placebo Placebo: Placebo match duloxetine for 6 week period.
General disorders Headache	100.0% 10/10 • 1, 3, and 6 weeks	100.0% 9/9 • 1, 3, and 6 weeks
Musculoskeletal and connective tissue disorders Osteoarthritis	100.0% 10/10 • 1, 3, and 6 weeks	100.0% 9/9 • 1, 3, and 6 weeks
Musculoskeletal and connective tissue disorders Fibromyalgia	100.0% 10/10 • 1, 3, and 6 weeks	100.0% 9/9 • 1, 3, and 6 weeks

Additional Information

Sharon Gordon, DDS

ECU SODM

Phone: 2527377125

Email: gordons@ecu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place