Trial Outcomes & Findings for Duloxetine in Osteoarthritis (OA) Pain (NCT NCT01558700)
NCT ID: NCT01558700
Last Updated: 2014-12-29
Results Overview
The change in gray matter volume is evaluated by subtracting the volume after the treatment (week 16) to the volume before treatment (baseline)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
40 participants
Primary outcome timeframe
16 weeks compared to baseline
Results posted on
2014-12-29
Participant Flow
Participant milestones
| Measure |
Duloxetine
Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week.
Duloxetine: Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week.
|
Sugar Pill
Matching capsule given once a day for a total of 17 weeks.
Sugar pill: Matching capsule given once a day for a total of 17 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
21
|
|
Overall Study
COMPLETED
|
19
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Duloxetine in Osteoarthritis (OA) Pain
Baseline characteristics by cohort
| Measure |
Duloxetine
n=19 Participants
Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week.
Duloxetine: Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week.
|
Sugar Pill
n=21 Participants
Matching capsule given once a day for a total of 17 weeks.
Sugar pill: Matching capsule given once a day for a total of 17 weeks.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Continuous
|
58.6 years
STANDARD_DEVIATION 4.2 • n=5 Participants
|
58.9 years
STANDARD_DEVIATION 8.6 • n=7 Participants
|
58.7 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
21 participants
n=7 Participants
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 16 weeks compared to baselineThe change in gray matter volume is evaluated by subtracting the volume after the treatment (week 16) to the volume before treatment (baseline)
Outcome measures
| Measure |
Duloxetine
n=19 Participants
Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week.
Duloxetine: Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week.
|
Sugar Pill
n=21 Participants
Matching capsule given once a day for a total of 17 weeks.
Sugar pill: Matching capsule given once a day for a total of 17 weeks.
|
|---|---|---|
|
Change in Brain Gray Matter Volume
|
-0.34 percentage of change
Standard Deviation 0.21
|
-0.92 percentage of change
Standard Deviation 0.19
|
SECONDARY outcome
Timeframe: 16 weeks compared to baselineThe Western Ontario and McMaster Osteoarthritis Index (WOMAC) score change was assess by subtracting WOMAC score after treatment (week 16) to the baseline WOMAC score. WOMAC score has a range from 0 up to 96, higher score meaning worse condition. The outcome is the decrease in WOMAC scores, meaning that the higher is the decrease, the most improvement in the condition.
Outcome measures
| Measure |
Duloxetine
n=19 Participants
Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week.
Duloxetine: Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week.
|
Sugar Pill
n=21 Participants
Matching capsule given once a day for a total of 17 weeks.
Sugar pill: Matching capsule given once a day for a total of 17 weeks.
|
|---|---|---|
|
Change in Pain Magnitude
|
8.3 Scores on a scale
Standard Deviation 6.1
|
8.7 Scores on a scale
Standard Deviation 6.4
|
Adverse Events
Duloxetine
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Sugar Pill
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Duloxetine
n=19 participants at risk
Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week.
Duloxetine: Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week.
|
Sugar Pill
n=21 participants at risk
Matching capsule given once a day for a total of 17 weeks.
Sugar pill: Matching capsule given once a day for a total of 17 weeks.
|
|---|---|---|
|
Nervous system disorders
dizziness, groggy
|
21.1%
4/19 • Number of events 4
|
14.3%
3/21 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
worsening knee pain
|
10.5%
2/19 • Number of events 2
|
14.3%
3/21 • Number of events 3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place