Trial Outcomes & Findings for Study of the Insomnia in Patients With Low Back Pain (NCT NCT00365976)
NCT ID: NCT00365976
Last Updated: 2015-07-24
Results Overview
Nightly total sleep time was averaged from diary entries.
COMPLETED
PHASE4
58 participants
Postnaprosyn baseline, Week 1, week 2, week 4
2015-07-24
Participant Flow
Seventy adult volunteers with low back pain who met diagnostic criteria for insomnia were recruited through newspaper advertisements, posted announcements and physician referrals. Of those 70, 10 did not meet inclusion criteria, and 2 chose not to participate. The remaining 58 were randomized.
Qualifying subjects were switched from their current pain regimen to naproxen and lansoprazole. We excluded those with: significant medical or neurological illness other than LBP; psychiatric disease impacting sleep; substance abuse; history of hypersensitivity or contraindication to NAP/LAN or ESZ; abnormalities on baseline laboratory tests.
Participant milestones
| Measure |
Eszopiclone
Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
|
Placebo
Placebo : Placebo nightly over duration of double blind study phase.
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
25
|
|
Overall Study
COMPLETED
|
32
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
5
|
Reasons for withdrawal
| Measure |
Eszopiclone
Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
|
Placebo
Placebo : Placebo nightly over duration of double blind study phase.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
5
|
Baseline Characteristics
Study of the Insomnia in Patients With Low Back Pain
Baseline characteristics by cohort
| Measure |
Eszopiclone
n=33 Participants
Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
|
Placebo
n=25 Participants
Placebo : Placebo nightly over duration of double blind study phase.
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
33 Participants
n=113 Participants
|
25 Participants
n=163 Participants
|
58 Participants
n=160 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Age, Continuous
|
45.7 years
STANDARD_DEVIATION 11.0 • n=113 Participants
|
40.1 years
STANDARD_DEVIATION 12.8 • n=163 Participants
|
43.5 years
STANDARD_DEVIATION 11.7 • n=160 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=113 Participants
|
18 Participants
n=163 Participants
|
38 Participants
n=160 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=113 Participants
|
7 Participants
n=163 Participants
|
20 Participants
n=160 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=113 Participants
|
25 participants
n=163 Participants
|
58 participants
n=160 Participants
|
PRIMARY outcome
Timeframe: Postnaprosyn baseline, Week 1, week 2, week 4Nightly total sleep time was averaged from diary entries.
Outcome measures
| Measure |
Eszopiclone
n=32 Participants
Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
|
Placebo
n=20 Participants
Placebo : Placebo nightly over duration of double blind study phase.
|
|---|---|---|
|
Mean Subjective Sleep Diary Derived Total Sleep Time (TST)
postnaprosyn baseline
|
316.96 Minutes
Standard Deviation 91.55
|
380.45 Minutes
Standard Deviation 81.33
|
|
Mean Subjective Sleep Diary Derived Total Sleep Time (TST)
week 1
|
403.47 Minutes
Standard Deviation 77.67
|
375.56 Minutes
Standard Deviation 88.74
|
|
Mean Subjective Sleep Diary Derived Total Sleep Time (TST)
week 2
|
421.97 Minutes
Standard Deviation 68.28
|
382.11 Minutes
Standard Deviation 96.13
|
|
Mean Subjective Sleep Diary Derived Total Sleep Time (TST)
Week 4
|
411.97 Minutes
Standard Deviation 66.87
|
388.96 Minutes
Standard Deviation 99.02
|
SECONDARY outcome
Timeframe: Postnaprosyn baseline, Week 1, Week 2, Week 4Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain
Outcome measures
| Measure |
Eszopiclone
n=32 Participants
Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
|
Placebo
n=20 Participants
Placebo : Placebo nightly over duration of double blind study phase.
|
|---|---|---|
|
Visual Analog Scale Pain Ratings (VAS)
Postnaprosyn Baseline
|
48.51 units on a scale
Standard Deviation 16.22
|
53.79 units on a scale
Standard Deviation 20.96
|
|
Visual Analog Scale Pain Ratings (VAS)
Week 1
|
40.72 units on a scale
Standard Deviation 17.13
|
51.99 units on a scale
Standard Deviation 20.83
|
|
Visual Analog Scale Pain Ratings (VAS)
Week 2
|
34.70 units on a scale
Standard Deviation 18.49
|
51.25 units on a scale
Standard Deviation 19.61
|
|
Visual Analog Scale Pain Ratings (VAS)
Week 4
|
31.69 units on a scale
Standard Deviation 17.92
|
51.60 units on a scale
Standard Deviation 22.44
|
SECONDARY outcome
Timeframe: Postnaprosyn Baseline, Week 1, Week 2 week 4Outcome measures
| Measure |
Eszopiclone
n=32 Participants
Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
|
Placebo
n=20 Participants
Placebo : Placebo nightly over duration of double blind study phase.
|
|---|---|---|
|
Mean Sleep Onset Latency (SOL)
Postnaprosyn Baseline
|
38.28 minutes
Standard Deviation 23.90
|
34.11 minutes
Standard Deviation 25.93
|
|
Mean Sleep Onset Latency (SOL)
Week 1
|
22.36 minutes
Standard Deviation 16.59
|
27.00 minutes
Standard Deviation 18.28
|
|
Mean Sleep Onset Latency (SOL)
Week 2
|
17.50 minutes
Standard Deviation 12.33
|
23.10 minutes
Standard Deviation 19.68
|
|
Mean Sleep Onset Latency (SOL)
Week 4
|
15.28 minutes
Standard Deviation 12.95
|
19.91 minutes
Standard Deviation 12.30
|
SECONDARY outcome
Timeframe: Postnaprosyn Baseline, Week 1, Week 2 week 4Outcome measures
| Measure |
Eszopiclone
n=32 Participants
Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
|
Placebo
n=20 Participants
Placebo : Placebo nightly over duration of double blind study phase.
|
|---|---|---|
|
Wake Time After Sleep Onset
Postnaprosyn Baseline
|
91.51 minutes
Standard Deviation 55.91
|
81.43 minutes
Standard Deviation 54.58
|
|
Wake Time After Sleep Onset
Week 1
|
49.34 minutes
Standard Deviation 32.62
|
76.71 minutes
Standard Deviation 65.84
|
|
Wake Time After Sleep Onset
Week 2
|
37.07 minutes
Standard Deviation 22.21
|
81.32 minutes
Standard Deviation 76.30
|
|
Wake Time After Sleep Onset
Week 4
|
36.74 minutes
Standard Deviation 28.44
|
76.18 minutes
Standard Deviation 65.50
|
SECONDARY outcome
Timeframe: Postnaprosyn Baseline, Week 1, Week 2 week 4Outcome measures
| Measure |
Eszopiclone
n=32 Participants
Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
|
Placebo
n=20 Participants
Placebo : Placebo nightly over duration of double blind study phase.
|
|---|---|---|
|
Number of Awakenings
Postnaprosyn Baseline
|
2.29 awakenings
Standard Deviation 1.48
|
2.08 awakenings
Standard Deviation 1.51
|
|
Number of Awakenings
Week 1
|
1.31 awakenings
Standard Deviation 1.02
|
1.98 awakenings
Standard Deviation 1.43
|
|
Number of Awakenings
Week 2
|
1.35 awakenings
Standard Deviation 0.99
|
2.13 awakenings
Standard Deviation 1.81
|
|
Number of Awakenings
Week 4
|
1.33 awakenings
Standard Deviation 1.01
|
2.34 awakenings
Standard Deviation 1.79
|
SECONDARY outcome
Timeframe: Postnaprosyn Baseline, Week 1, Week 2 week 4Sleep quality ratings are based on a 1-10 Likert scale. Low scores represent poorer sleep quality and higher scores represent better quality sleep
Outcome measures
| Measure |
Eszopiclone
n=32 Participants
Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
|
Placebo
n=20 Participants
Placebo : Placebo nightly over duration of double blind study phase.
|
|---|---|---|
|
Sleep Quality Ratings
Postnaprosyn Baseline
|
4.52 units on a scale
Standard Deviation 1.45
|
4.44 units on a scale
Standard Deviation 1.66
|
|
Sleep Quality Ratings
Week 1
|
5.99 units on a scale
Standard Deviation 1.43
|
4.90 units on a scale
Standard Deviation 1.83
|
|
Sleep Quality Ratings
Week 2
|
6.18 units on a scale
Standard Deviation 1.45
|
5.33 units on a scale
Standard Deviation 1.77
|
|
Sleep Quality Ratings
Week 4
|
6.38 units on a scale
Standard Deviation 1.66
|
5.29 units on a scale
Standard Deviation 2.00
|
SECONDARY outcome
Timeframe: Prenaprosyn Baseline, Postnaprosyn Baseline, Week 1, Week 2 week 4The ISI is a seven-item self-report questionnaire that provides a global measure of insomnia severity based on difficulty falling or staying asleep, satisfaction with sleep, or degree of impairment with daytime functioning. The total score ranges from 0-28: 0-7 (no clinical insomnia), 8-14 (subthreshold insomnia), 15-21 (insomnia of moderate severity), and 22-28 (severe insomnia).
Outcome measures
| Measure |
Eszopiclone
n=32 Participants
Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
|
Placebo
n=20 Participants
Placebo : Placebo nightly over duration of double blind study phase.
|
|---|---|---|
|
Insomnia Severity Index (ISI)
Postnaprosyn baseline
|
18.00 units on a scale
Standard Deviation 3.41
|
16.78 units on a scale
Standard Deviation 4.32
|
|
Insomnia Severity Index (ISI)
Week 1
|
11.28 units on a scale
Standard Deviation 6.10
|
12.85 units on a scale
Standard Deviation 5.97
|
|
Insomnia Severity Index (ISI)
Prenaprosyn Baseline
|
18.85 units on a scale
Standard Deviation 4.01
|
20.26 units on a scale
Standard Deviation 4.07
|
|
Insomnia Severity Index (ISI)
Week 2
|
10.61 units on a scale
Standard Deviation 6.60
|
12.74 units on a scale
Standard Deviation 6.39
|
|
Insomnia Severity Index (ISI)
Week 4
|
8.38 units on a scale
Standard Deviation 6.42
|
13.75 units on a scale
Standard Deviation 6.78
|
SECONDARY outcome
Timeframe: postnaprosyn Baseline, Week 1, Week 2 week 4Pain ratings included a global impression of pain rating (PGI) (1-5 rating with 1 being little pain and 5 is worst pain)
Outcome measures
| Measure |
Eszopiclone
n=32 Participants
Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
|
Placebo
n=20 Participants
Placebo : Placebo nightly over duration of double blind study phase.
|
|---|---|---|
|
Patient Global Impression of Pain Ratings
postnaprosyn Baseline
|
4.02 units on a scale
Standard Deviation 0.95
|
3.90 units on a scale
Standard Deviation 1.47
|
|
Patient Global Impression of Pain Ratings
Week 1
|
3.54 units on a scale
Standard Deviation 1.17
|
3.82 units on a scale
Standard Deviation 1.45
|
|
Patient Global Impression of Pain Ratings
Week 2
|
3.30 units on a scale
Standard Deviation 1.27
|
4.01 units on a scale
Standard Deviation 1.12
|
|
Patient Global Impression of Pain Ratings
Week 4
|
3.08 units on a scale
Standard Deviation 1.28
|
3.80 units on a scale
Standard Deviation 1.14
|
SECONDARY outcome
Timeframe: prenaprosyn baseline, postnaprosyn Baseline, Week 1, Week 2, week 4The Roland-Morris Low Back Pain Disability Questionnaire (RMLBPDQ) is a 24-item instrument that assesses the extent to which activities of daily living are affected by LBP. It is composed of 24 "yes-no" items assessing potential disabilities. Scores range from 0 (no disability) to 24 (severe disability).
Outcome measures
| Measure |
Eszopiclone
n=32 Participants
Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
|
Placebo
n=20 Participants
Placebo : Placebo nightly over duration of double blind study phase.
|
|---|---|---|
|
Roland Morris Low Back Pain Inventory (RMLBPI)
postnaprosyn Baseline
|
9.97 units on a scale
Standard Deviation 5.55
|
10.30 units on a scale
Standard Deviation 5.75
|
|
Roland Morris Low Back Pain Inventory (RMLBPI)
prenaprosyn Baseline
|
12.27 units on a scale
Standard Deviation 5.70
|
11.33 units on a scale
Standard Deviation 5.66
|
|
Roland Morris Low Back Pain Inventory (RMLBPI)
Week 1
|
9.10 units on a scale
Standard Deviation 6.37
|
9.05 units on a scale
Standard Deviation 6.32
|
|
Roland Morris Low Back Pain Inventory (RMLBPI)
Week 2
|
7.63 units on a scale
Standard Deviation 6.34
|
9.32 units on a scale
Standard Deviation 6.25
|
|
Roland Morris Low Back Pain Inventory (RMLBPI)
Week 4
|
6.59 units on a scale
Standard Deviation 5.49
|
7.94 units on a scale
Standard Deviation 6.99
|
SECONDARY outcome
Timeframe: prenaprosyn baseline, postnaprosyn Baseline, Week 1, Week 2, week 4The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 76. The higher the score, the more severe.
Outcome measures
| Measure |
Eszopiclone
n=32 Participants
Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
|
Placebo
n=20 Participants
Placebo : Placebo nightly over duration of double blind study phase.
|
|---|---|---|
|
Hamilton Depression Rating Scale (HAM-D-24)
Week 1
|
4.54 units on a scale
Standard Deviation 3.71
|
5.53 units on a scale
Standard Deviation 3.28
|
|
Hamilton Depression Rating Scale (HAM-D-24)
Week 2
|
4.14 units on a scale
Standard Deviation 3.50
|
5.07 units on a scale
Standard Deviation 3.61
|
|
Hamilton Depression Rating Scale (HAM-D-24)
prenaprosyn Baseline
|
6.45 units on a scale
Standard Deviation 2.26
|
7.10 units on a scale
Standard Deviation 3.83
|
|
Hamilton Depression Rating Scale (HAM-D-24)
postnaprosyn Baseline
|
6.38 units on a scale
Standard Deviation 2.37
|
6.57 units on a scale
Standard Deviation 3.63
|
|
Hamilton Depression Rating Scale (HAM-D-24)
Week 4
|
2.62 units on a scale
Standard Deviation 2.61
|
6.21 units on a scale
Standard Deviation 5.18
|
SECONDARY outcome
Timeframe: Baseline, week 1, week 2, week 4Population: Data not collected.
The SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The vitality sub-score assesses energy and fatigue, and ranges from 0 (worst) - 100 (best).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, week 1, week 2, week 4Population: Data not collected.
Self-rating assessment of anxiety measured by STAI, state anxiety inventory (Scale 40-160, where a lower value shows a larger improvement)
Outcome measures
Outcome data not reported
Adverse Events
Eszopiclone
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60