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Insomnia and Osteoarthritis Study

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ClinicalTrials.gov Identifier: NCT00374556
Recruitment Status : Completed
First Posted : September 11, 2006
Results First Posted : November 9, 2017
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Osteoarthritis
Insomnia
Interventions Drug: Placebo
Drug: Eszopiclone
Enrollment 30
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Eszopiclone Placebo
Hide Arm/Group Description

Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks

Eszopiclone: 3mg capsule, once daily at bedtime

3mg placebo capsule, once daily at bedtime for 12 weeks

Placebo: 3mg placebo capsule, once daily at bedtime

Period Title: Overall Study
Started 14 16
Completed 13 15
Not Completed 1 1
Reason Not Completed
Lost to Follow-up             1             0
Removed at baseline due to medical cond             0             1
Arm/Group Title Eszopiclone Placebo Total
Hide Arm/Group Description

Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks

Eszopiclone: 3mg capsule, once daily at bedtime

3mg placebo capsule, once daily at bedtime for 12 weeks

Placebo: 3mg placebo capsule, once daily at bedtime

Total of all reporting groups
Overall Number of Baseline Participants 14 15 29
Hide Baseline Analysis Population Description
Baseline characteristics were only calculated for the 29 participants above. 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.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 15 participants 29 participants
54.64  (5.18) 52.93  (6.64) 53.76  (5.94)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 15 participants 29 participants
Female
11
  78.6%
8
  53.3%
19
  65.5%
Male
3
  21.4%
7
  46.7%
10
  34.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants 15 participants 29 participants
14 15 29
Kellgren Lawrence OA grade   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 14 participants 15 participants 29 participants
Right knee 2.08  (0.86) 1.53  (0.91) 1.79  (0.92)
Left Knee 2.07  (1.07) 1.79  (1.05) 1.93  (1.05)
[1]
Measure Description: grade 0: no radiographic features of osteoarthritis (OA) are present grade 1: doubtful joint space narrowing (JSN) and possible osteophytic lipping grade 2: definite osteophytes and possible JSN on anteroposterior weight-bearing radiograph grade 3: multiple osteophytes, definite JSN, sclerosis, possible bony deformity grade 4: large osteophytes, marked JSN, severe sclerosis and definite bony deformity
Kellgren Lawrence OA grade >=3 in either knee   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 14 participants 15 participants 29 participants
6 4 10
[1]
Measure Description: grade 0: no radiographic features of OA are present grade 1: doubtful joint space narrowing (JSN) and possible osteophytic lipping grade 2: definite osteophytes and possible JSN on anteroposterior weight-bearing radiograph grade 3: multiple osteophytes, definite JSN, sclerosis, possible bony deformity grade 4: large osteophytes, marked JSN, severe sclerosis and definite bony deformity
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 14 participants 15 participants 29 participants
29.41  (5.21) 31.36  (6.53) 30.42  (5.91)
Duration of OA  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 14 participants 15 participants 29 participants
87.7  (98.06) 108.5  (95.11) 95.6  (95.69)
1.Primary Outcome
Title Wake After Sleep Onset (WASO)
Hide Description 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
Time Frame Mean of baseline, 6 week follow-up, and 12 week follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
Arm/Group Title Placebo Eszopiclone
Hide Arm/Group Description:

3mg placebo capsule, once daily at bedtime for 12 weeks

Placebo: 3mg placebo capsule, once daily at bedtime

Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks

Eszopiclone: 3mg capsule, once daily at bedtime

Overall Number of Participants Analyzed 15 10
Mean (Standard Deviation)
Unit of Measure: minutes
Baseline Number Analyzed 15 participants 10 participants
117.33  (108.09) 88.0  (57.26)
6 week follow-up Number Analyzed 15 participants 9 participants
81.00  (98.76) 65.56  (67.28)
12 week follow-up Number Analyzed 9 participants 7 participants
61.94  (55.59) 58.57  (51.85)
2.Primary Outcome
Title Time in Bed
Hide Description Total time in bed, in minutes
Time Frame Mean of baseline, 6 week follow-up, and 12 week follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
Arm/Group Title Placebo Eszopiclone
Hide Arm/Group Description:

3mg placebo capsule, once daily at bedtime for 12 weeks

Placebo: 3mg placebo capsule, once daily at bedtime

Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks

Eszopiclone: 3mg capsule, once daily at bedtime

Overall Number of Participants Analyzed 15 10
Mean (Standard Deviation)
Unit of Measure: minutes
Baseline Number Analyzed 15 participants 10 participants
464.00  (134.31) 608.00  (243.48)
6 week follow-up Number Analyzed 15 participants 9 participants
506.00  (120.22) 577.77  (130.26)
12 week follow-up Number Analyzed 9 participants 7 participants
523.33  (128.55) 592.85  (113.39)
3.Primary Outcome
Title Sleep Latency (SL)
Hide Description Sleep Latency: time taken to fall asleep, in minutes (as recorded in daily sleep diary)
Time Frame Mean of baseline, 6 week follow-up, and 12 week follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
Arm/Group Title Placebo Eszopiclone
Hide Arm/Group Description:

3mg placebo capsule, once daily at bedtime for 12 weeks

Placebo: 3mg placebo capsule, once daily at bedtime

Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks

Eszopiclone: 3mg capsule, once daily at bedtime

Overall Number of Participants Analyzed 15 10
Mean (Standard Deviation)
Unit of Measure: minutes
Baseline Number Analyzed 15 participants 10 participants
58.33  (51.01) 47.50  (30.21)
6 week follow-up Number Analyzed 15 participants 9 participants
45.00  (41.96) 33.33  (21.50)
12 week follow-up Number Analyzed 9 participants 7 participants
31.38  (26.98) 41.42  (40.28)
4.Primary Outcome
Title Number of Awakenings
Hide Description As recorded in daily sleep diary
Time Frame Mean of baseline, 6 week follow-up, and 12 week follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
Arm/Group Title Placebo Eszopiclone
Hide Arm/Group Description:

3mg placebo capsule, once daily at bedtime for 12 weeks

Placebo: 3mg placebo capsule, once daily at bedtime

Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks

Eszopiclone: 3mg capsule, once daily at bedtime

Overall Number of Participants Analyzed 15 10
Mean (Standard Deviation)
Unit of Measure: number of awakenings
Baseline Number Analyzed 15 participants 10 participants
3.53  (1.84) 3.70  (2.11)
6 week follow-up Number Analyzed 15 participants 9 participants
3.06  (1.27) 3.11  (1.76)
12 week follow-up Number Analyzed 9 participants 7 participants
2.38  (0.78) 3.42  (1.99)
5.Primary Outcome
Title Total Sleep Time (TST)
Hide Description minutes spent asleep as recorded in daily sleep diary
Time Frame Mean of baseline, 6 week follow-up, and 12 week follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
Arm/Group Title Placebo Eszopiclone
Hide Arm/Group Description:

3mg placebo capsule, once daily at bedtime for 12 weeks

Placebo: 3mg placebo capsule, once daily at bedtime

Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks

Eszopiclone: 3mg capsule, once daily at bedtime

Overall Number of Participants Analyzed 15 10
Mean (Standard Deviation)
Unit of Measure: minutes
Baseline Number Analyzed 15 participants 10 participants
255.66  (172.57) 370.50  (184.98)
6 week follow-up Number Analyzed 15 participants 9 participants
339.33  (161.04) 454.44  (178.68)
12 week follow-up Number Analyzed 9 participants 7 participants
409.44  (80.98) 437.14  (118.73)
6.Primary Outcome
Title Sleep Efficiency (SE)
Hide Description [(TST/ TIB)X 100], (%) as recorded in daily sleep diary
Time Frame Mean of baseline, 6 week follow-up, and 12 week follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
Arm/Group Title Placebo Eszopiclone
Hide Arm/Group Description:

3mg placebo capsule, once daily at bedtime for 12 weeks

Placebo: 3mg placebo capsule, once daily at bedtime

Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks

Eszopiclone: 3mg capsule, once daily at bedtime

Overall Number of Participants Analyzed 15 10
Mean (Standard Deviation)
Unit of Measure: percentage of efficient sleep
Baseline Number Analyzed 15 participants 10 participants
55.54  (62.44) 62.44  (20.73)
6 week follow-up Number Analyzed 15 participants 9 participants
66.31  (24.01) 77.48  (15.32)
12 week follow-up Number Analyzed 9 participants 7 participants
80.07  (11.65) 75.06  (19.30)
7.Primary Outcome
Title Sleep Quality (SQ)
Hide Description 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)
Time Frame Mean of baseline, 6 week follow-up, and 12 week follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
Arm/Group Title Placebo Eszopiclone
Hide Arm/Group Description:

3mg placebo capsule, once daily at bedtime for 12 weeks

Placebo: 3mg placebo capsule, once daily at bedtime

Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks

Eszopiclone: 3mg capsule, once daily at bedtime

Overall Number of Participants Analyzed 15 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 15 participants 10 participants
44.40  (18.86) 37.90  (13.89)
6 week follow-up Number Analyzed 15 participants 9 participants
52.46  (19.96) 55.33  (19.93)
12 week follow-up Number Analyzed 9 participants 7 participants
59.16  (23.12) 55.71  (11.85)
8.Primary Outcome
Title WASO as Assessed by Actigraphy
Hide Description 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.
Time Frame Mean of baseline, 6 week follow-up, and 12 week follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
Arm/Group Title Placebo Eszopiclone
Hide Arm/Group Description:

3mg placebo capsule, once daily at bedtime for 12 weeks

Placebo: 3mg placebo capsule, once daily at bedtime

Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks

Eszopiclone: 3mg capsule, once daily at bedtime

Overall Number of Participants Analyzed 14 12
Mean (Standard Deviation)
Unit of Measure: minutes
Baseline Number Analyzed 14 participants 12 participants
64.70  (39.14) 59.43  (15.81)
6 week follow-up Number Analyzed 14 participants 11 participants
56.30  (25.34) 56.06  (250.80)
12 week follow-up Number Analyzed 11 participants 9 participants
59.70  (39.18) 65.29  (17.99)
9.Primary Outcome
Title TST as Assessed by Actigraphy
Hide Description 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
Time Frame Mean of baseline, 6 week follow-up, and 12 week follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
Arm/Group Title Placebo Eszopiclone
Hide Arm/Group Description:

3mg placebo capsule, once daily at bedtime for 12 weeks

Placebo: 3mg placebo capsule, once daily at bedtime

Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks

Eszopiclone: 3mg capsule, once daily at bedtime

Overall Number of Participants Analyzed 14 12
Mean (Standard Deviation)
Unit of Measure: minutes
Baseline Number Analyzed 14 participants 12 participants
340.07  (71.23) 367.95  (79.73)
6 week follow-up Number Analyzed 14 participants 12 participants
337.93  (75.00) 405.88  (79.29)
12 week follow-up Number Analyzed 11 participants 9 participants
336.84  (87.63) 394.77  (96.86)
10.Primary Outcome
Title Sleep Efficiency as Assessed by Actigraphy
Hide Description 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%.
Time Frame Mean of baseline, 6 week follow-up, and 12 week follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
Arm/Group Title Placebo Eszopiclone
Hide Arm/Group Description:

3mg placebo capsule, once daily at bedtime for 12 weeks

Placebo: 3mg placebo capsule, once daily at bedtime

Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks

Eszopiclone: 3mg capsule, once daily at bedtime

Overall Number of Participants Analyzed 14 12
Mean (Standard Deviation)
Unit of Measure: percentage of time asleep
Baseline Number Analyzed 14 participants 12 participants
73.32  (12.34) 76.83  (8.74)
6 week follow-up Number Analyzed 14 participants 11 participants
74.77  (8.87) 79.94  (7.49)
12 week follow-up Number Analyzed 14 participants 12 participants
73.95  (14.15) 75.16  (7.58)
11.Primary Outcome
Title Sleep Latency as Assessed by Actigraphy
Hide Description 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).
Time Frame Mean of baseline, 6 week follow-up, and 12 week follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
Arm/Group Title Placebo Eszopiclone
Hide Arm/Group Description:

3mg placebo capsule, once daily at bedtime for 12 weeks

Placebo: 3mg placebo capsule, once daily at bedtime

Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks

Eszopiclone: 3mg capsule, once daily at bedtime

Overall Number of Participants Analyzed 14 12
Mean (Standard Deviation)
Unit of Measure: minutes
Baseline Number Analyzed 14 participants 12 participants
46.25  (58.44) 26.79  (24.73)
6 week follow-up Number Analyzed 14 participants 11 participants
39.31  (48.31) 24.87  (17.06)
12 week follow-up Number Analyzed 11 participants 9 participants
24.71  (27.42) 38.89  (23.49)
12.Primary Outcome
Title Insomnia Severity Index (ISI) Mean Total Scores
Hide Description 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
Time Frame Mean of baseline, 6 week follow-up, and 12 week follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not included for all participants, as some were unable to complete the task.
Arm/Group Title Placebo Eszopiclone
Hide Arm/Group Description:

3mg placebo capsule, once daily at bedtime for 12 weeks

Placebo: 3mg placebo capsule, once daily at bedtime

Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks

Eszopiclone: 3mg capsule, once daily at bedtime

Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 14 participants 11 participants
15.64  (6.02) 16.64  (4.98)
6 week follow-up Number Analyzed 14 participants 14 participants
12.57  (4.65) 10.71  (6.38)
12 week follow-up Number Analyzed 12 participants 13 participants
10.25  (5.19) 13  (6.33)
13.Primary Outcome
Title Diffuse Noxious Inhibitory Control (DNIC) Index Scores
Hide Description 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.
Time Frame Mean of baseline, 6 week follow-up and 12 week follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
Arm/Group Title Placebo Eszopiclone
Hide Arm/Group Description:

3mg placebo capsule, once daily at bedtime for 12 weeks

Placebo: 3mg placebo capsule, once daily at bedtime

Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks

Eszopiclone: 3mg capsule, once daily at bedtime

Overall Number of Participants Analyzed 14 13
Mean (Standard Deviation)
Unit of Measure: percentage change of PPTh
Baseline Number Analyzed 14 participants 13 participants
1.23  (0.30) 1.19  (0.15)
6 week follow-up Number Analyzed 14 participants 12 participants
1.26  (0.31) 1.23  (0.25)
12 week follow-up Number Analyzed 12 participants 12 participants
1.16  (0.24) 1.14  (0.19)
14.Primary Outcome
Title Temporal Summation (TS)
Hide Description 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
Time Frame Mean of baseline, 6 week follow-up and 12 week follow-up at 46, 48, and 50 degrees C
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
Arm/Group Title Placebo Eszopiclone
Hide Arm/Group Description:

3mg placebo capsule, once daily at bedtime for 12 weeks

Placebo: 3mg placebo capsule, once daily at bedtime

Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks

Eszopiclone: 3mg capsule, once daily at bedtime

Overall Number of Participants Analyzed 15 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 46 degrees C Number Analyzed 15 participants 11 participants
9.20  (16.08) 7.80  (12.93)
6 week follow-up 46 degrees C Number Analyzed 12 participants 11 participants
6.41  (9.69) 6.50  (7.47)
12 week follow-up 46 degrees C Number Analyzed 13 participants 9 participants
5.22  (7.45) 3.33  (7.07)
Baseline 48 degrees C Number Analyzed 15 participants 11 participants
20.40  (41.90) 4.72  (6.77)
6 week follow-up 48 degrees C Number Analyzed 12 participants 9 participants
5.75  (8.72) 8.11  (11.38)
12 week follow-up 48 degrees C Number Analyzed 13 participants 9 participants
5.23  (8.70) 4.55  (4.13)
Baseline 50 degrees C Number Analyzed 15 participants 10 participants
17.06  (23.09) 21.00  (20.25)
6 week follow-up 50 degrees C Number Analyzed 11 participants 10 participants
13.27  (19.66) 18.00  (20.30)
12 week follow-up 50 degrees C Number Analyzed 13 participants 9 participants
18.84  (23.82) 20.77  (28.92)
15.Primary Outcome
Title Mean Level of Pain Experienced Throughout the Day
Hide Description Assessed using a Daily Pain Diary with a scale 0-100, 0 being no pain, 100 being the most severe/intense
Time Frame Mean of baseline, 6 week follow-up and 12 week follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
Arm/Group Title Placebo Eszopiclone
Hide Arm/Group Description:

3mg placebo capsule, once daily at bedtime for 12 weeks

Placebo: 3mg placebo capsule, once daily at bedtime

Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks

Eszopiclone: 3mg capsule, once daily at bedtime

Overall Number of Participants Analyzed 15 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 15 participants 10 participants
48.79  (19.63) 52.40  (18.87)
6 week follow-up Number Analyzed 14 participants 8 participants
42.21  (18.34) 44.43  (28.39)
12 week follow-up Number Analyzed 9 participants 7 participants
38.12  (19.11) 42.88  (25.53)
16.Primary Outcome
Title Pain as Assessed by the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Pain Severity Subscale
Hide Description 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.
Time Frame Mean of baseline, 6 week follow-up and 12 week follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
Arm/Group Title Placebo Eszopiclone
Hide Arm/Group Description:

3mg placebo capsule, once daily at bedtime for 12 weeks

Placebo: 3mg placebo capsule, once daily at bedtime

Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks

Eszopiclone: 3mg capsule, once daily at bedtime

Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 12 participants 11 participants
21.62  (10.75) 24.88  (13.79)
6 week follow-up Number Analyzed 14 participants 14 participants
19.18  (12.03) 24.41  (13.74)
12 week follow-up Number Analyzed 13 participants 14 participants
14.85  (11.04) 19.89  (14.15)
17.Secondary Outcome
Title Heat Pain Threshold
Hide Description 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.
Time Frame Mean of baseline, 6 week follow-up and 12 week follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
Arm/Group Title Placebo Eszopiclone
Hide Arm/Group Description:

3mg placebo capsule, once daily at bedtime for 12 weeks

Placebo: 3mg placebo capsule, once daily at bedtime

Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks

Eszopiclone: 3mg capsule, once daily at bedtime

Overall Number of Participants Analyzed 15 14
Mean (Standard Deviation)
Unit of Measure: degrees Celsius
Baseline Number Analyzed 15 participants 13 participants
43.38  (4.71) 42.77  (3.51)
6 week follow-up Number Analyzed 15 participants 14 participants
43.41  (5.41) 42.19  (3.95)
12 week follow-up Number Analyzed 14 participants 13 participants
43.31  (4.61) 42.49  (4.38)
18.Secondary Outcome
Title Heat Pain Tolerance (HPTOL)
Hide Description 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.
Time Frame Mean of baseline, 6 week follow-up and 12 week follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
Arm/Group Title Placebo Eszopiclone
Hide Arm/Group Description:

3mg placebo capsule, once daily at bedtime for 12 weeks

Placebo: 3mg placebo capsule, once daily at bedtime

Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks

Eszopiclone: 3mg capsule, once daily at bedtime

Overall Number of Participants Analyzed 15 14
Mean (Standard Deviation)
Unit of Measure: degrees Celsius
Baseline Number Analyzed 15 participants 13 participants
47.65  (2.28) 46.56  (2.80)
6 week follow-up Number Analyzed 15 participants 14 participants
47.54  (2.26) 46.87  (3.56)
12 week follow-up Number Analyzed 14 participants 13 participants
47.92  (2.24) 46.67  (3.93)
19.Secondary Outcome
Title Pressure Pain Threshold
Hide Description 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
Time Frame Mean of baseline, 6 week follow-up and 12 week follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
Arm/Group Title Placebo Eszopiclone
Hide Arm/Group Description:

3mg placebo capsule, once daily at bedtime for 12 weeks

Placebo: 3mg placebo capsule, once daily at bedtime

Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks

Eszopiclone: 3mg capsule, once daily at bedtime

Overall Number of Participants Analyzed 15 14
Mean (Standard Deviation)
Unit of Measure: kPA
Baseline 300.91  (111.13) 267.93  (111.50)
6 week follow-up 322.24  (107.82) 287.29  (107.01)
12 week follow-up 381.92  (199.33) 309.15  (81.16)
20.Secondary Outcome
Title Quality of Life as Assessed by the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Disability Subscale
Hide Description 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.
Time Frame Mean of baseline, 6 week follow-up and 12 week follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
Arm/Group Title Placebo Eszopiclone
Hide Arm/Group Description:

3mg placebo capsule, once daily at bedtime for 12 weeks

Placebo: 3mg placebo capsule, once daily at bedtime

Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks

Eszopiclone: 3mg capsule, once daily at bedtime

Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 12 participants 11 participants
64.32  (41.26) 74.69  (46.18)
6 week follow-up Number Analyzed 14 participants 14 participants
62.26  (45.878) 79.71  (47.79)
12 week follow-up Number Analyzed 13 participants 14 participants
56.13  (48.11) 70.44  (50.75)
21.Secondary Outcome
Title Quality of Life as Assessed by the Short Form-36 (SF-36) Physical Health Component Summary
Hide Description 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.
Time Frame Mean of baseline, 6 week follow-up and 12 week follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
Arm/Group Title Placebo Eszopiclone
Hide Arm/Group Description:

3mg placebo capsule, once daily at bedtime for 12 weeks

Placebo: 3mg placebo capsule, once daily at bedtime

Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks

Eszopiclone: 3mg capsule, once daily at bedtime

Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 13 participants 11 participants
57.61  (25.91) 52.73  (23.38)
6 week follow-up Number Analyzed 14 participants 14 participants
60.60  (27.48) 49.44  (28.94)
12 week follow-up Number Analyzed 13 participants 13 participants
65.00  (21.69) 49.40  (28.41)
22.Secondary Outcome
Title Quality of Life as Assessed by the Short Form-36 (SF-36) Mental Health Component Summary
Hide Description 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.
Time Frame Mean of baseline, 6 week follow-up and 12 week follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
Arm/Group Title Placebo Eszopiclone
Hide Arm/Group Description:

3mg placebo capsule, once daily at bedtime for 12 weeks

Placebo: 3mg placebo capsule, once daily at bedtime

Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks

Eszopiclone: 3mg capsule, once daily at bedtime

Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 13 participants 11 participants
50.40  (9.56) 45.78  (7.88)
6 week follow-up Number Analyzed 14 participants 14 participants
51.68  (7.73) 45.86  (7.06)
12 week follow-up Number Analyzed 13 participants 13 participants
50.71  (5.89) 47.04  (11.05)
23.Secondary Outcome
Title Joint Stiffness as Assessed by the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Joint Stiffness Subscale
Hide Description 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.
Time Frame Mean of baseline, 6 week follow-up and 12 week follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
Arm/Group Title Placebo Eszopiclone
Hide Arm/Group Description:

3mg placebo capsule, once daily at bedtime for 12 weeks

Placebo: 3mg placebo capsule, once daily at bedtime

Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks

Eszopiclone: 3mg capsule, once daily at bedtime

Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 12 participants 11 participants
10.17  (5.60) 12.86  (5.05)
6 week follow-up Number Analyzed 14 participants 14 participants
7.55  (5.74) 12.17  (4.41)
12 week follow-up Number Analyzed 13 participants 14 participants
6.86  (5.89) 11.32  (5.61)
Time Frame Participants were followed for study duration, up to 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Eszopiclone
Hide Arm/Group Description

3mg placebo capsule, once daily at bedtime for 12 weeks

Placebo: 3mg placebo capsule, once daily at bedtime

Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks

Eszopiclone: 3mg capsule, once daily at bedtime

All-Cause Mortality
Placebo Eszopiclone
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)      0/14 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Eszopiclone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/16 (0.00%)      0/14 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Eszopiclone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/16 (31.25%)      7/14 (50.00%)    
Product Issues     
Other Mild to Moderate (Not Recorded) [1]  5/16 (31.25%)  5 6/14 (42.86%)  6
Psychiatric disorders     
Restlessness, anxiety, agitation  0/16 (0.00%)  0 1/14 (7.14%)  1
[1]
It is noted that no serious adverse events (AEs) occurred. Only the number of participants who experienced mild to moderate AEs is available & has been reported. However, further information in regards to the specific AE has since been lost.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Michael Smith, PhD, Associate Professor of Psychiatry, Director of Behavioral Medicine
Organization: Johns Hopkins University School of Medicine
Phone: 410-550-7000
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00374556     History of Changes
Other Study ID Numbers: NA_00001703
First Submitted: September 8, 2006
First Posted: September 11, 2006
Results First Submitted: August 25, 2017
Results First Posted: November 9, 2017
Last Update Posted: March 14, 2019