Trial Outcomes & Findings for Insomnia and Osteoarthritis Study (NCT NCT00374556)
NCT ID: NCT00374556
Last Updated: 2019-03-14
Results Overview
Total minutes of wakefulness recorded after sleep onset. (Recorded in Daily Sleep Diary) WASO= time awake in the middle of the night, not counting SL or time in bed after awakening. Recorded in minutes
COMPLETED
NA
30 participants
Mean of baseline, 6 week follow-up, and 12 week follow-up
2019-03-14
Participant Flow
105 were assessed for eligibility. 75 were excluded based on not meeting inclusion criteria. 30 were randomized to one of 2 arms. One subject after randomization ( to placebo condition) was determined to be ineligible due to failing sleep apnea entry criteria. They were removed from the study and did not contribute to baseline data.
Participant milestones
| Measure |
Eszopiclone
Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks
Eszopiclone: 3mg capsule, once daily at bedtime
|
Placebo
3mg placebo capsule, once daily at bedtime for 12 weeks
Placebo: 3mg placebo capsule, once daily at bedtime
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
16
|
|
Overall Study
COMPLETED
|
13
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Eszopiclone
Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks
Eszopiclone: 3mg capsule, once daily at bedtime
|
Placebo
3mg placebo capsule, once daily at bedtime for 12 weeks
Placebo: 3mg placebo capsule, once daily at bedtime
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Removed at baseline due to medical cond
|
0
|
1
|
Baseline Characteristics
Insomnia and Osteoarthritis Study
Baseline characteristics by cohort
| Measure |
Eszopiclone
n=14 Participants
Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks
Eszopiclone: 3mg capsule, once daily at bedtime
|
Placebo
n=15 Participants
3mg placebo capsule, once daily at bedtime for 12 weeks
Placebo: 3mg placebo capsule, once daily at bedtime
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.64 years
STANDARD_DEVIATION 5.18 • n=93 Participants
|
52.93 years
STANDARD_DEVIATION 6.64 • n=4 Participants
|
53.76 years
STANDARD_DEVIATION 5.94 • n=27 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=93 Participants
|
15 participants
n=4 Participants
|
29 participants
n=27 Participants
|
|
Kellgren Lawrence OA grade
Right knee
|
2.08 units on a scale
STANDARD_DEVIATION 0.86 • n=93 Participants
|
1.53 units on a scale
STANDARD_DEVIATION 0.91 • n=4 Participants
|
1.79 units on a scale
STANDARD_DEVIATION 0.92 • n=27 Participants
|
|
Kellgren Lawrence OA grade
Left Knee
|
2.07 units on a scale
STANDARD_DEVIATION 1.07 • n=93 Participants
|
1.79 units on a scale
STANDARD_DEVIATION 1.05 • n=4 Participants
|
1.93 units on a scale
STANDARD_DEVIATION 1.05 • n=27 Participants
|
|
Kellgren Lawrence OA grade >=3 in either knee
|
6 participants
n=93 Participants
|
4 participants
n=4 Participants
|
10 participants
n=27 Participants
|
|
BMI
|
29.41 kg/m^2
STANDARD_DEVIATION 5.21 • n=93 Participants
|
31.36 kg/m^2
STANDARD_DEVIATION 6.53 • n=4 Participants
|
30.42 kg/m^2
STANDARD_DEVIATION 5.91 • n=27 Participants
|
|
Duration of OA
|
87.7 months
STANDARD_DEVIATION 98.06 • n=93 Participants
|
108.5 months
STANDARD_DEVIATION 95.11 • n=4 Participants
|
95.6 months
STANDARD_DEVIATION 95.69 • n=27 Participants
|
PRIMARY outcome
Timeframe: Mean of baseline, 6 week follow-up, and 12 week follow-upPopulation: Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
Total minutes of wakefulness recorded after sleep onset. (Recorded in Daily Sleep Diary) WASO= time awake in the middle of the night, not counting SL or time in bed after awakening. Recorded in minutes
Outcome measures
| Measure |
Placebo
n=15 Participants
3mg placebo capsule, once daily at bedtime for 12 weeks
Placebo: 3mg placebo capsule, once daily at bedtime
|
Eszopiclone
n=10 Participants
Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks
Eszopiclone: 3mg capsule, once daily at bedtime
|
|---|---|---|
|
Wake After Sleep Onset (WASO)
Baseline
|
117.33 minutes
Standard Deviation 108.09
|
88.0 minutes
Standard Deviation 57.26
|
|
Wake After Sleep Onset (WASO)
6 week follow-up
|
81.00 minutes
Standard Deviation 98.76
|
65.56 minutes
Standard Deviation 67.28
|
|
Wake After Sleep Onset (WASO)
12 week follow-up
|
61.94 minutes
Standard Deviation 55.59
|
58.57 minutes
Standard Deviation 51.85
|
PRIMARY outcome
Timeframe: Mean of baseline, 6 week follow-up, and 12 week follow-upPopulation: Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
Total time in bed, in minutes
Outcome measures
| Measure |
Placebo
n=15 Participants
3mg placebo capsule, once daily at bedtime for 12 weeks
Placebo: 3mg placebo capsule, once daily at bedtime
|
Eszopiclone
n=10 Participants
Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks
Eszopiclone: 3mg capsule, once daily at bedtime
|
|---|---|---|
|
Time in Bed
Baseline
|
464.00 minutes
Standard Deviation 134.31
|
608.00 minutes
Standard Deviation 243.48
|
|
Time in Bed
6 week follow-up
|
506.00 minutes
Standard Deviation 120.22
|
577.77 minutes
Standard Deviation 130.26
|
|
Time in Bed
12 week follow-up
|
523.33 minutes
Standard Deviation 128.55
|
592.85 minutes
Standard Deviation 113.39
|
PRIMARY outcome
Timeframe: Mean of baseline, 6 week follow-up, and 12 week follow-upPopulation: Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
Sleep Latency: time taken to fall asleep, in minutes (as recorded in daily sleep diary)
Outcome measures
| Measure |
Placebo
n=15 Participants
3mg placebo capsule, once daily at bedtime for 12 weeks
Placebo: 3mg placebo capsule, once daily at bedtime
|
Eszopiclone
n=10 Participants
Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks
Eszopiclone: 3mg capsule, once daily at bedtime
|
|---|---|---|
|
Sleep Latency (SL)
Baseline
|
58.33 minutes
Standard Deviation 51.01
|
47.50 minutes
Standard Deviation 30.21
|
|
Sleep Latency (SL)
6 week follow-up
|
45.00 minutes
Standard Deviation 41.96
|
33.33 minutes
Standard Deviation 21.50
|
|
Sleep Latency (SL)
12 week follow-up
|
31.38 minutes
Standard Deviation 26.98
|
41.42 minutes
Standard Deviation 40.28
|
PRIMARY outcome
Timeframe: Mean of baseline, 6 week follow-up, and 12 week follow-upPopulation: Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
As recorded in daily sleep diary
Outcome measures
| Measure |
Placebo
n=15 Participants
3mg placebo capsule, once daily at bedtime for 12 weeks
Placebo: 3mg placebo capsule, once daily at bedtime
|
Eszopiclone
n=10 Participants
Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks
Eszopiclone: 3mg capsule, once daily at bedtime
|
|---|---|---|
|
Number of Awakenings
Baseline
|
3.53 number of awakenings
Standard Deviation 1.84
|
3.70 number of awakenings
Standard Deviation 2.11
|
|
Number of Awakenings
6 week follow-up
|
3.06 number of awakenings
Standard Deviation 1.27
|
3.11 number of awakenings
Standard Deviation 1.76
|
|
Number of Awakenings
12 week follow-up
|
2.38 number of awakenings
Standard Deviation 0.78
|
3.42 number of awakenings
Standard Deviation 1.99
|
PRIMARY outcome
Timeframe: Mean of baseline, 6 week follow-up, and 12 week follow-upPopulation: Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
minutes spent asleep as recorded in daily sleep diary
Outcome measures
| Measure |
Placebo
n=15 Participants
3mg placebo capsule, once daily at bedtime for 12 weeks
Placebo: 3mg placebo capsule, once daily at bedtime
|
Eszopiclone
n=10 Participants
Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks
Eszopiclone: 3mg capsule, once daily at bedtime
|
|---|---|---|
|
Total Sleep Time (TST)
Baseline
|
255.66 minutes
Standard Deviation 172.57
|
370.50 minutes
Standard Deviation 184.98
|
|
Total Sleep Time (TST)
6 week follow-up
|
339.33 minutes
Standard Deviation 161.04
|
454.44 minutes
Standard Deviation 178.68
|
|
Total Sleep Time (TST)
12 week follow-up
|
409.44 minutes
Standard Deviation 80.98
|
437.14 minutes
Standard Deviation 118.73
|
PRIMARY outcome
Timeframe: Mean of baseline, 6 week follow-up, and 12 week follow-upPopulation: Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
\[(TST/ TIB)X 100\], (%) as recorded in daily sleep diary
Outcome measures
| Measure |
Placebo
n=15 Participants
3mg placebo capsule, once daily at bedtime for 12 weeks
Placebo: 3mg placebo capsule, once daily at bedtime
|
Eszopiclone
n=10 Participants
Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks
Eszopiclone: 3mg capsule, once daily at bedtime
|
|---|---|---|
|
Sleep Efficiency (SE)
12 week follow-up
|
80.07 percentage of efficient sleep
Standard Deviation 11.65
|
75.06 percentage of efficient sleep
Standard Deviation 19.30
|
|
Sleep Efficiency (SE)
Baseline
|
55.54 percentage of efficient sleep
Standard Deviation 62.44
|
62.44 percentage of efficient sleep
Standard Deviation 20.73
|
|
Sleep Efficiency (SE)
6 week follow-up
|
66.31 percentage of efficient sleep
Standard Deviation 24.01
|
77.48 percentage of efficient sleep
Standard Deviation 15.32
|
PRIMARY outcome
Timeframe: Mean of baseline, 6 week follow-up, and 12 week follow-upPopulation: Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
As recorded in daily sleep diary. Visual analog scales (VAS) Sleep Quality Ratings 0-100, 0= extremely poor sleep quality, (shallow and unrefreshing) and 100=excellent sleep quality (deep and refreshing)
Outcome measures
| Measure |
Placebo
n=15 Participants
3mg placebo capsule, once daily at bedtime for 12 weeks
Placebo: 3mg placebo capsule, once daily at bedtime
|
Eszopiclone
n=10 Participants
Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks
Eszopiclone: 3mg capsule, once daily at bedtime
|
|---|---|---|
|
Sleep Quality (SQ)
Baseline
|
44.40 units on a scale
Standard Deviation 18.86
|
37.90 units on a scale
Standard Deviation 13.89
|
|
Sleep Quality (SQ)
6 week follow-up
|
52.46 units on a scale
Standard Deviation 19.96
|
55.33 units on a scale
Standard Deviation 19.93
|
|
Sleep Quality (SQ)
12 week follow-up
|
59.16 units on a scale
Standard Deviation 23.12
|
55.71 units on a scale
Standard Deviation 11.85
|
PRIMARY outcome
Timeframe: Mean of baseline, 6 week follow-up, and 12 week follow-upPopulation: Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
Subjects wore a Mini Mitter Actiwatch for two continuous weeks at each assessment periods to provide an objective index compared to the assessments made by daily sleep journal. Device is lightweight and worn on non-dominant wrist and contains and omni-directional accelerometer. The accelerometer records the occurrence and degree of motion with a minimal resultant force of .01g. Data are stored as activity counts within a specified epoch. WASO recorded by device = total minutes of wakefulness after sleep onset, in minutes.
Outcome measures
| Measure |
Placebo
n=14 Participants
3mg placebo capsule, once daily at bedtime for 12 weeks
Placebo: 3mg placebo capsule, once daily at bedtime
|
Eszopiclone
n=12 Participants
Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks
Eszopiclone: 3mg capsule, once daily at bedtime
|
|---|---|---|
|
WASO as Assessed by Actigraphy
Baseline
|
64.70 minutes
Standard Deviation 39.14
|
59.43 minutes
Standard Deviation 15.81
|
|
WASO as Assessed by Actigraphy
6 week follow-up
|
56.30 minutes
Standard Deviation 25.34
|
56.06 minutes
Standard Deviation 250.80
|
|
WASO as Assessed by Actigraphy
12 week follow-up
|
59.70 minutes
Standard Deviation 39.18
|
65.29 minutes
Standard Deviation 17.99
|
PRIMARY outcome
Timeframe: Mean of baseline, 6 week follow-up, and 12 week follow-upPopulation: Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
Subjects wore a Mini Mitter Actiwatch for two continuous weeks at each assessment periods to provide an objective index compared to the assessments made by daily sleep journal. Device is lightweight and worn on non-dominant wrist and contains and omni-directional accelerometer. The accelerometer records the occurrence and degree of motion with a minimal resultant force of .01g. Data are stored as activity counts within a specified epoch. TST recorded by device = total minutes spent asleep
Outcome measures
| Measure |
Placebo
n=14 Participants
3mg placebo capsule, once daily at bedtime for 12 weeks
Placebo: 3mg placebo capsule, once daily at bedtime
|
Eszopiclone
n=12 Participants
Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks
Eszopiclone: 3mg capsule, once daily at bedtime
|
|---|---|---|
|
TST as Assessed by Actigraphy
6 week follow-up
|
337.93 minutes
Standard Deviation 75.00
|
405.88 minutes
Standard Deviation 79.29
|
|
TST as Assessed by Actigraphy
12 week follow-up
|
336.84 minutes
Standard Deviation 87.63
|
394.77 minutes
Standard Deviation 96.86
|
|
TST as Assessed by Actigraphy
Baseline
|
340.07 minutes
Standard Deviation 71.23
|
367.95 minutes
Standard Deviation 79.73
|
PRIMARY outcome
Timeframe: Mean of baseline, 6 week follow-up, and 12 week follow-upPopulation: Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
Subjects wore a Mini Mitter Actiwatch for two continuous weeks at each assessment periods to provide an objective index compared to the assessments made by daily sleep journal. Device is lightweight and worn on non-dominant wrist and contains and omni-directional accelerometer. The accelerometer records the occurrence and degree of motion with a minimal resultant force of .01g. Data are stored as activity counts within a specified epoch. Sleep efficiency is the index of sleep percentage recorded, equal to total sleep time divided by the time in bed X 100 = X%.
Outcome measures
| Measure |
Placebo
n=14 Participants
3mg placebo capsule, once daily at bedtime for 12 weeks
Placebo: 3mg placebo capsule, once daily at bedtime
|
Eszopiclone
n=12 Participants
Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks
Eszopiclone: 3mg capsule, once daily at bedtime
|
|---|---|---|
|
Sleep Efficiency as Assessed by Actigraphy
Baseline
|
73.32 percentage of time asleep
Standard Deviation 12.34
|
76.83 percentage of time asleep
Standard Deviation 8.74
|
|
Sleep Efficiency as Assessed by Actigraphy
6 week follow-up
|
74.77 percentage of time asleep
Standard Deviation 8.87
|
79.94 percentage of time asleep
Standard Deviation 7.49
|
|
Sleep Efficiency as Assessed by Actigraphy
12 week follow-up
|
73.95 percentage of time asleep
Standard Deviation 14.15
|
75.16 percentage of time asleep
Standard Deviation 7.58
|
PRIMARY outcome
Timeframe: Mean of baseline, 6 week follow-up, and 12 week follow-upPopulation: Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
Subjects wore a Mini Mitter Actiwatch for two continuous weeks at each assessment periods to provide an objective index compared to the assessments made by daily sleep journal. Device is lightweight and worn on non-dominant wrist and contains and omni-directional accelerometer. The accelerometer records the occurrence and degree of motion with a minimal resultant force of .01g. Data are stored as activity counts within a specified epoch. Sleep latency is the time taken to fall asleep, or equal to lights out- sleep onset (sleep onset: time when sleep is first scored after lights out, first scorable epoch).
Outcome measures
| Measure |
Placebo
n=14 Participants
3mg placebo capsule, once daily at bedtime for 12 weeks
Placebo: 3mg placebo capsule, once daily at bedtime
|
Eszopiclone
n=12 Participants
Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks
Eszopiclone: 3mg capsule, once daily at bedtime
|
|---|---|---|
|
Sleep Latency as Assessed by Actigraphy
Baseline
|
46.25 minutes
Standard Deviation 58.44
|
26.79 minutes
Standard Deviation 24.73
|
|
Sleep Latency as Assessed by Actigraphy
6 week follow-up
|
39.31 minutes
Standard Deviation 48.31
|
24.87 minutes
Standard Deviation 17.06
|
|
Sleep Latency as Assessed by Actigraphy
12 week follow-up
|
24.71 minutes
Standard Deviation 27.42
|
38.89 minutes
Standard Deviation 23.49
|
PRIMARY outcome
Timeframe: Mean of baseline, 6 week follow-up, and 12 week follow-upPopulation: Data was not included for all participants, as some were unable to complete the task.
The ISI is made up of 7 questions, each possible of earning a score of 0-4, making the total range 0-28, where 0 indicates no severity/no problem with sleep and therefore no insomnia, or 28, being very severe with the highest level of insomnia
Outcome measures
| Measure |
Placebo
n=14 Participants
3mg placebo capsule, once daily at bedtime for 12 weeks
Placebo: 3mg placebo capsule, once daily at bedtime
|
Eszopiclone
n=14 Participants
Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks
Eszopiclone: 3mg capsule, once daily at bedtime
|
|---|---|---|
|
Insomnia Severity Index (ISI) Mean Total Scores
Baseline
|
15.64 units on a scale
Standard Deviation 6.02
|
16.64 units on a scale
Standard Deviation 4.98
|
|
Insomnia Severity Index (ISI) Mean Total Scores
6 week follow-up
|
12.57 units on a scale
Standard Deviation 4.65
|
10.71 units on a scale
Standard Deviation 6.38
|
|
Insomnia Severity Index (ISI) Mean Total Scores
12 week follow-up
|
10.25 units on a scale
Standard Deviation 5.19
|
13 units on a scale
Standard Deviation 6.33
|
PRIMARY outcome
Timeframe: Mean of baseline, 6 week follow-up and 12 week follow-upPopulation: Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
PPTh:a somedic algometer's 1cm2 rubber probe was placed over muscle belly, with pressure increasing steadily at constant rate (30kPA/Sec), until subject indicated that s/he "first felt pain." PPTh ratings were obtained on right brachioradialis \& right trapezius in a random order (average was taken from both areas at each time point). During each cold pressor task, participants immersed contralateral hand (left) up to wrist, in a circulating cold water bath maintained at 4°C. 20 seconds after commencing hand immersion, PPTh was re-assessed on either right brachioradialis or right trapezius (the same site as baseline assessment). After PPTh assessment, participants removed hands from water. DNIC was measured as the % change in PPTh during cold pressor, relative to baseline PPTh \[i.e., (mean PPTh during cold pressor / mean PPTh prior to cold pressor)\*100\]. Increase in PPTh during cold pressor (i.e., percentage scores above 100) reflects normal functioning of pain-inhibitory processes.
Outcome measures
| Measure |
Placebo
n=14 Participants
3mg placebo capsule, once daily at bedtime for 12 weeks
Placebo: 3mg placebo capsule, once daily at bedtime
|
Eszopiclone
n=13 Participants
Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks
Eszopiclone: 3mg capsule, once daily at bedtime
|
|---|---|---|
|
Diffuse Noxious Inhibitory Control (DNIC) Index Scores
6 week follow-up
|
1.26 percentage change of PPTh
Standard Deviation 0.31
|
1.23 percentage change of PPTh
Standard Deviation 0.25
|
|
Diffuse Noxious Inhibitory Control (DNIC) Index Scores
12 week follow-up
|
1.16 percentage change of PPTh
Standard Deviation 0.24
|
1.14 percentage change of PPTh
Standard Deviation 0.19
|
|
Diffuse Noxious Inhibitory Control (DNIC) Index Scores
Baseline
|
1.23 percentage change of PPTh
Standard Deviation 0.30
|
1.19 percentage change of PPTh
Standard Deviation 0.15
|
PRIMARY outcome
Timeframe: Mean of baseline, 6 week follow-up and 12 week follow-up at 46, 48, and 50 degrees CPopulation: Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
TS :maximum windup pain rating - first windup pain rating (0-100). Contact heat stimuli at non tissue damaging temperatures were delivered using computer driven, peltier-element-based stimulator (Medoc, TSA II), with a 9 cm2 probe applied to left forearm. In order to assess temporal summation, three sequences of 10 heat pulses each (with stimulus temperatures of 46 degrees C, 48 degrees C, and 50 degrees C, in random order) were applied to left dorsal forearm. The thermode remains in fixed position during administration of 10 heat pulses that constitute a sequence. Within each sequence, successive thermal pulses at a given temperature are delivered for a duration of approximately 0.5 sec each, with a 2.5-sec inter-pulse interval. The rate of rise \& fall of the thermode temp. is set at the device max .of 10 degrees C / S. Subjects verbally rate the perceived intensity of each thermal pulse on a 0-100 rating scale \& may terminate the procedure at any time.100=max tolerable intensity
Outcome measures
| Measure |
Placebo
n=15 Participants
3mg placebo capsule, once daily at bedtime for 12 weeks
Placebo: 3mg placebo capsule, once daily at bedtime
|
Eszopiclone
n=11 Participants
Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks
Eszopiclone: 3mg capsule, once daily at bedtime
|
|---|---|---|
|
Temporal Summation (TS)
6 week follow-up 46 degrees C
|
6.41 units on a scale
Standard Deviation 9.69
|
6.50 units on a scale
Standard Deviation 7.47
|
|
Temporal Summation (TS)
6 week follow-up 48 degrees C
|
5.75 units on a scale
Standard Deviation 8.72
|
8.11 units on a scale
Standard Deviation 11.38
|
|
Temporal Summation (TS)
Baseline 50 degrees C
|
17.06 units on a scale
Standard Deviation 23.09
|
21.00 units on a scale
Standard Deviation 20.25
|
|
Temporal Summation (TS)
6 week follow-up 50 degrees C
|
13.27 units on a scale
Standard Deviation 19.66
|
18.00 units on a scale
Standard Deviation 20.30
|
|
Temporal Summation (TS)
12 week follow-up 50 degrees C
|
18.84 units on a scale
Standard Deviation 23.82
|
20.77 units on a scale
Standard Deviation 28.92
|
|
Temporal Summation (TS)
Baseline 46 degrees C
|
9.20 units on a scale
Standard Deviation 16.08
|
7.80 units on a scale
Standard Deviation 12.93
|
|
Temporal Summation (TS)
12 week follow-up 46 degrees C
|
5.22 units on a scale
Standard Deviation 7.45
|
3.33 units on a scale
Standard Deviation 7.07
|
|
Temporal Summation (TS)
Baseline 48 degrees C
|
20.40 units on a scale
Standard Deviation 41.90
|
4.72 units on a scale
Standard Deviation 6.77
|
|
Temporal Summation (TS)
12 week follow-up 48 degrees C
|
5.23 units on a scale
Standard Deviation 8.70
|
4.55 units on a scale
Standard Deviation 4.13
|
PRIMARY outcome
Timeframe: Mean of baseline, 6 week follow-up and 12 week follow-upPopulation: Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
Assessed using a Daily Pain Diary with a scale 0-100, 0 being no pain, 100 being the most severe/intense
Outcome measures
| Measure |
Placebo
n=15 Participants
3mg placebo capsule, once daily at bedtime for 12 weeks
Placebo: 3mg placebo capsule, once daily at bedtime
|
Eszopiclone
n=10 Participants
Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks
Eszopiclone: 3mg capsule, once daily at bedtime
|
|---|---|---|
|
Mean Level of Pain Experienced Throughout the Day
Baseline
|
48.79 units on a scale
Standard Deviation 19.63
|
52.40 units on a scale
Standard Deviation 18.87
|
|
Mean Level of Pain Experienced Throughout the Day
12 week follow-up
|
38.12 units on a scale
Standard Deviation 19.11
|
42.88 units on a scale
Standard Deviation 25.53
|
|
Mean Level of Pain Experienced Throughout the Day
6 week follow-up
|
42.21 units on a scale
Standard Deviation 18.34
|
44.43 units on a scale
Standard Deviation 28.39
|
PRIMARY outcome
Timeframe: Mean of baseline, 6 week follow-up and 12 week follow-upPopulation: Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
The WOMAC is a quality of scale life made up of three domains, pain, stiffness, and disability which each comprising of 5, 2, and 7 questions, respectively. A VAS was used for each subscale. Pain was assessed on a scale of 0-100, with 0 being absolutely no pain and 100 being maximum pain.
Outcome measures
| Measure |
Placebo
n=14 Participants
3mg placebo capsule, once daily at bedtime for 12 weeks
Placebo: 3mg placebo capsule, once daily at bedtime
|
Eszopiclone
n=14 Participants
Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks
Eszopiclone: 3mg capsule, once daily at bedtime
|
|---|---|---|
|
Pain as Assessed by the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Pain Severity Subscale
12 week follow-up
|
14.85 units on a scale
Standard Deviation 11.04
|
19.89 units on a scale
Standard Deviation 14.15
|
|
Pain as Assessed by the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Pain Severity Subscale
Baseline
|
21.62 units on a scale
Standard Deviation 10.75
|
24.88 units on a scale
Standard Deviation 13.79
|
|
Pain as Assessed by the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Pain Severity Subscale
6 week follow-up
|
19.18 units on a scale
Standard Deviation 12.03
|
24.41 units on a scale
Standard Deviation 13.74
|
SECONDARY outcome
Timeframe: Mean of baseline, 6 week follow-up and 12 week follow-upPopulation: Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
Contact heat stimuli at non tissue damaging temperatures were delivered using computer driven, peltier-element-based stimulator (Medoc, TSA II), with a 9 cm2 probe applied to the left forearm. The thermode was affixed snugly via Velcro straps to ensure even skin contact and repositioned to an adjacent site after each trial to minimize sensitizationHPTh was assessed on the left ventral forearm using an ascending method of limits paradigm; from a non-painful 32°C baseline, the temperature was steadily increased at 0.5°C/sec. Two trials of heat pain threshold were conducted. Averages of both trials are presented from respective time point below. Subjects push a button when the stimulus "first feels painful" The temperature (degrees Celsius) at the time button is pushed is automatically recorded.
Outcome measures
| Measure |
Placebo
n=15 Participants
3mg placebo capsule, once daily at bedtime for 12 weeks
Placebo: 3mg placebo capsule, once daily at bedtime
|
Eszopiclone
n=14 Participants
Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks
Eszopiclone: 3mg capsule, once daily at bedtime
|
|---|---|---|
|
Heat Pain Threshold
6 week follow-up
|
43.41 degrees Celsius
Standard Deviation 5.41
|
42.19 degrees Celsius
Standard Deviation 3.95
|
|
Heat Pain Threshold
Baseline
|
43.38 degrees Celsius
Standard Deviation 4.71
|
42.77 degrees Celsius
Standard Deviation 3.51
|
|
Heat Pain Threshold
12 week follow-up
|
43.31 degrees Celsius
Standard Deviation 4.61
|
42.49 degrees Celsius
Standard Deviation 4.38
|
SECONDARY outcome
Timeframe: Mean of baseline, 6 week follow-up and 12 week follow-upPopulation: Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
Contact heat stimuli at non tissue damaging temperatures were delivered using computer driven, peltier-element-based stimulator (Medoc, TSA II), with a 9 cm2 probe applied to the left forearm. The thermode was affixed snugly via Velcro straps to ensure even skin contact and repositioned to an adjacent site after each trial to minimize sensitization. HPTOL was assessed on the left ventral forearm using an ascending method of limits paradigm; from a non-painful 32°C baseline, the temperature was steadily increased at 0.5°C/sec. Two trials of HPTOL were conducted. An average of both trials at each respective time point is presented below. Subjects push a button when the stimulus "becomes intolerable." The temperature (degrees Celsius) at the time button is pushed to terminate the stimulation is automatically recorded.
Outcome measures
| Measure |
Placebo
n=15 Participants
3mg placebo capsule, once daily at bedtime for 12 weeks
Placebo: 3mg placebo capsule, once daily at bedtime
|
Eszopiclone
n=14 Participants
Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks
Eszopiclone: 3mg capsule, once daily at bedtime
|
|---|---|---|
|
Heat Pain Tolerance (HPTOL)
Baseline
|
47.65 degrees Celsius
Standard Deviation 2.28
|
46.56 degrees Celsius
Standard Deviation 2.80
|
|
Heat Pain Tolerance (HPTOL)
6 week follow-up
|
47.54 degrees Celsius
Standard Deviation 2.26
|
46.87 degrees Celsius
Standard Deviation 3.56
|
|
Heat Pain Tolerance (HPTOL)
12 week follow-up
|
47.92 degrees Celsius
Standard Deviation 2.24
|
46.67 degrees Celsius
Standard Deviation 3.93
|
SECONDARY outcome
Timeframe: Mean of baseline, 6 week follow-up and 12 week follow-upPopulation: Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
A Somedic algometer was used to assess pressure pain threshold (PPTh) similar to previous studies. The algometer's 1cm2 rubber probe was placed over the muscle belly, with the pressure increased steadily at a constant rate (30kPA/Sec), until the subject indicated that s/he "first felt pain." PPTh was assessed 2 times each, bilaterally, at (in a randomized order) the masseter muscle trapezius muscle, and at the proximal third of the brachioradialis muscle (forearm). The scores from each location were averaged for each participant at that respective time point. The same site was never stimulated consecutively. At least 90 s were maintained between successive stimuli
Outcome measures
| Measure |
Placebo
n=15 Participants
3mg placebo capsule, once daily at bedtime for 12 weeks
Placebo: 3mg placebo capsule, once daily at bedtime
|
Eszopiclone
n=14 Participants
Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks
Eszopiclone: 3mg capsule, once daily at bedtime
|
|---|---|---|
|
Pressure Pain Threshold
6 week follow-up
|
322.24 kPA
Standard Deviation 107.82
|
287.29 kPA
Standard Deviation 107.01
|
|
Pressure Pain Threshold
12 week follow-up
|
381.92 kPA
Standard Deviation 199.33
|
309.15 kPA
Standard Deviation 81.16
|
|
Pressure Pain Threshold
Baseline
|
300.91 kPA
Standard Deviation 111.13
|
267.93 kPA
Standard Deviation 111.50
|
SECONDARY outcome
Timeframe: Mean of baseline, 6 week follow-up and 12 week follow-upPopulation: Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
The WOMAC is a quality of scale life made up of three domains, pain, stiffness, and disability which each comprising of 5, 2, and 7 questions, respectively. A VAS was used for each subscale. Disability was assessed on a VAS of 0-100, with 0 being absolutely no disability and 100 being maximum disability.
Outcome measures
| Measure |
Placebo
n=14 Participants
3mg placebo capsule, once daily at bedtime for 12 weeks
Placebo: 3mg placebo capsule, once daily at bedtime
|
Eszopiclone
n=14 Participants
Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks
Eszopiclone: 3mg capsule, once daily at bedtime
|
|---|---|---|
|
Quality of Life as Assessed by the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Disability Subscale
Baseline
|
64.32 units on a scale
Standard Deviation 41.26
|
74.69 units on a scale
Standard Deviation 46.18
|
|
Quality of Life as Assessed by the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Disability Subscale
6 week follow-up
|
62.26 units on a scale
Standard Deviation 45.878
|
79.71 units on a scale
Standard Deviation 47.79
|
|
Quality of Life as Assessed by the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Disability Subscale
12 week follow-up
|
56.13 units on a scale
Standard Deviation 48.11
|
70.44 units on a scale
Standard Deviation 50.75
|
SECONDARY outcome
Timeframe: Mean of baseline, 6 week follow-up and 12 week follow-upPopulation: Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
The SF-36 is a broad, well normed measure of quality of life, comprised of 36 questions aggregated into 8 domains/dimensions. The Physical Component Summary was used here as a global index of physical health functioning. Scale 0-100, with 0 being worst functional level, 100 being the best.
Outcome measures
| Measure |
Placebo
n=14 Participants
3mg placebo capsule, once daily at bedtime for 12 weeks
Placebo: 3mg placebo capsule, once daily at bedtime
|
Eszopiclone
n=14 Participants
Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks
Eszopiclone: 3mg capsule, once daily at bedtime
|
|---|---|---|
|
Quality of Life as Assessed by the Short Form-36 (SF-36) Physical Health Component Summary
Baseline
|
57.61 units on a scale
Standard Deviation 25.91
|
52.73 units on a scale
Standard Deviation 23.38
|
|
Quality of Life as Assessed by the Short Form-36 (SF-36) Physical Health Component Summary
12 week follow-up
|
65.00 units on a scale
Standard Deviation 21.69
|
49.40 units on a scale
Standard Deviation 28.41
|
|
Quality of Life as Assessed by the Short Form-36 (SF-36) Physical Health Component Summary
6 week follow-up
|
60.60 units on a scale
Standard Deviation 27.48
|
49.44 units on a scale
Standard Deviation 28.94
|
SECONDARY outcome
Timeframe: Mean of baseline, 6 week follow-up and 12 week follow-upPopulation: Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
The SF-36 is a broad, well normed measure of quality of life, comprised of 36 questions aggregated into 8 domains/dimensions. The Mental Component Summary was used here as a global index of mental health functioning. Scale 0-100, with 0 being worst functional level, 100 being the best.
Outcome measures
| Measure |
Placebo
n=14 Participants
3mg placebo capsule, once daily at bedtime for 12 weeks
Placebo: 3mg placebo capsule, once daily at bedtime
|
Eszopiclone
n=14 Participants
Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks
Eszopiclone: 3mg capsule, once daily at bedtime
|
|---|---|---|
|
Quality of Life as Assessed by the Short Form-36 (SF-36) Mental Health Component Summary
Baseline
|
50.40 units on a scale
Standard Deviation 9.56
|
45.78 units on a scale
Standard Deviation 7.88
|
|
Quality of Life as Assessed by the Short Form-36 (SF-36) Mental Health Component Summary
6 week follow-up
|
51.68 units on a scale
Standard Deviation 7.73
|
45.86 units on a scale
Standard Deviation 7.06
|
|
Quality of Life as Assessed by the Short Form-36 (SF-36) Mental Health Component Summary
12 week follow-up
|
50.71 units on a scale
Standard Deviation 5.89
|
47.04 units on a scale
Standard Deviation 11.05
|
SECONDARY outcome
Timeframe: Mean of baseline, 6 week follow-up and 12 week follow-upPopulation: Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
The WOMAC is a quality of scale life made up of three domains, pain, stiffness, and disability which each comprising of 5, 2, and 7 questions, respectively. A VAS was used for each subscale. Joint Stiffness was assessed on a VAS scale of 0-20, with 0 being no joint stiffness, and 20 being maximum stiffness.
Outcome measures
| Measure |
Placebo
n=14 Participants
3mg placebo capsule, once daily at bedtime for 12 weeks
Placebo: 3mg placebo capsule, once daily at bedtime
|
Eszopiclone
n=14 Participants
Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks
Eszopiclone: 3mg capsule, once daily at bedtime
|
|---|---|---|
|
Joint Stiffness as Assessed by the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Joint Stiffness Subscale
Baseline
|
10.17 units on a scale
Standard Deviation 5.60
|
12.86 units on a scale
Standard Deviation 5.05
|
|
Joint Stiffness as Assessed by the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Joint Stiffness Subscale
6 week follow-up
|
7.55 units on a scale
Standard Deviation 5.74
|
12.17 units on a scale
Standard Deviation 4.41
|
|
Joint Stiffness as Assessed by the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Joint Stiffness Subscale
12 week follow-up
|
6.86 units on a scale
Standard Deviation 5.89
|
11.32 units on a scale
Standard Deviation 5.61
|
Adverse Events
Placebo
Eszopiclone
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=16 participants at risk
3mg placebo capsule, once daily at bedtime for 12 weeks
Placebo: 3mg placebo capsule, once daily at bedtime
|
Eszopiclone
n=14 participants at risk
Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks
Eszopiclone: 3mg capsule, once daily at bedtime
|
|---|---|---|
|
Psychiatric disorders
Restlessness, anxiety, agitation
|
0.00%
0/16 • Participants were followed for study duration, up to 12 weeks
|
7.1%
1/14 • Number of events 1 • Participants were followed for study duration, up to 12 weeks
|
|
Product Issues
Other Mild to Moderate (Not Recorded)
|
31.2%
5/16 • Number of events 5 • Participants were followed for study duration, up to 12 weeks
|
42.9%
6/14 • Number of events 6 • Participants were followed for study duration, up to 12 weeks
|
Additional Information
Michael Smith, PhD, Associate Professor of Psychiatry, Director of Behavioral Medicine
Johns Hopkins University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place