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Study of the Insomnia in Patients With Low Back Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00365976
Recruitment Status : Completed
First Posted : August 18, 2006
Results First Posted : June 7, 2013
Last Update Posted : July 24, 2015
Sponsor:
Collaborator:
Sunovion
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Primary Insomnia
Interventions Drug: Eszopiclone
Drug: Placebo
Enrollment 58
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Eszopiclone Placebo
Hide Arm/Group Description Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase. Placebo : Placebo nightly over duration of double blind study phase.
Period Title: Overall Study
Started 33 25
Completed 32 20
Not Completed 1 5
Reason Not Completed
Withdrawal by Subject             1             5
Arm/Group Title Eszopiclone Placebo Total
Hide Arm/Group Description Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase. Placebo : Placebo nightly over duration of double blind study phase. Total of all reporting groups
Overall Number of Baseline Participants 33 25 58
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 25 participants 58 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
33
 100.0%
25
 100.0%
58
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants 25 participants 58 participants
45.7  (11.0) 40.1  (12.8) 43.5  (11.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 25 participants 58 participants
Female
20
  60.6%
18
  72.0%
38
  65.5%
Male
13
  39.4%
7
  28.0%
20
  34.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 33 participants 25 participants 58 participants
33 25 58
1.Primary Outcome
Title Mean Subjective Sleep Diary Derived Total Sleep Time (TST)
Hide Description Nightly total sleep time was averaged from diary entries.
Time Frame Postnaprosyn baseline, Week 1, week 2, week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eszopiclone Placebo
Hide Arm/Group Description:
Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
Placebo : Placebo nightly over duration of double blind study phase.
Overall Number of Participants Analyzed 32 20
Mean (Standard Deviation)
Unit of Measure: Minutes
postnaprosyn baseline 316.96  (91.55) 380.45  (81.33)
week 1 403.47  (77.67) 375.56  (88.74)
week 2 421.97  (68.28) 382.11  (96.13)
Week 4 411.97  (66.87) 388.96  (99.02)
2.Secondary Outcome
Title Visual Analog Scale Pain Ratings (VAS)
Hide Description Scores 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
Time Frame Postnaprosyn baseline, Week 1, Week 2, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eszopiclone Placebo
Hide Arm/Group Description:
Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
Placebo : Placebo nightly over duration of double blind study phase.
Overall Number of Participants Analyzed 32 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
Postnaprosyn Baseline 48.51  (16.22) 53.79  (20.96)
Week 1 40.72  (17.13) 51.99  (20.83)
Week 2 34.70  (18.49) 51.25  (19.61)
Week 4 31.69  (17.92) 51.60  (22.44)
3.Secondary Outcome
Title Mean Sleep Onset Latency (SOL)
Hide Description [Not Specified]
Time Frame Postnaprosyn Baseline, Week 1, Week 2 week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eszopiclone Placebo
Hide Arm/Group Description:
Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
Placebo : Placebo nightly over duration of double blind study phase.
Overall Number of Participants Analyzed 32 20
Mean (Standard Deviation)
Unit of Measure: minutes
Postnaprosyn Baseline 38.28  (23.90) 34.11  (25.93)
Week 1 22.36  (16.59) 27.00  (18.28)
Week 2 17.50  (12.33) 23.10  (19.68)
Week 4 15.28  (12.95) 19.91  (12.30)
4.Secondary Outcome
Title Wake Time After Sleep Onset
Hide Description [Not Specified]
Time Frame Postnaprosyn Baseline, Week 1, Week 2 week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eszopiclone Placebo
Hide Arm/Group Description:
Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
Placebo : Placebo nightly over duration of double blind study phase.
Overall Number of Participants Analyzed 32 20
Mean (Standard Deviation)
Unit of Measure: minutes
Postnaprosyn Baseline 91.51  (55.91) 81.43  (54.58)
Week 1 49.34  (32.62) 76.71  (65.84)
Week 2 37.07  (22.21) 81.32  (76.30)
Week 4 36.74  (28.44) 76.18  (65.50)
5.Secondary Outcome
Title Number of Awakenings
Hide Description [Not Specified]
Time Frame Postnaprosyn Baseline, Week 1, Week 2 week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eszopiclone Placebo
Hide Arm/Group Description:
Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
Placebo : Placebo nightly over duration of double blind study phase.
Overall Number of Participants Analyzed 32 20
Mean (Standard Deviation)
Unit of Measure: awakenings
Postnaprosyn Baseline 2.29  (1.48) 2.08  (1.51)
Week 1 1.31  (1.02) 1.98  (1.43)
Week 2 1.35  (0.99) 2.13  (1.81)
Week 4 1.33  (1.01) 2.34  (1.79)
6.Secondary Outcome
Title Sleep Quality Ratings
Hide Description Sleep quality ratings are based on a 1-10 Likert scale. Low scores represent poorer sleep quality and higher scores represent better quality sleep
Time Frame Postnaprosyn Baseline, Week 1, Week 2 week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eszopiclone Placebo
Hide Arm/Group Description:
Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
Placebo : Placebo nightly over duration of double blind study phase.
Overall Number of Participants Analyzed 32 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
Postnaprosyn Baseline 4.52  (1.45) 4.44  (1.66)
Week 1 5.99  (1.43) 4.90  (1.83)
Week 2 6.18  (1.45) 5.33  (1.77)
Week 4 6.38  (1.66) 5.29  (2.00)
7.Secondary Outcome
Title Insomnia Severity Index (ISI)
Hide Description The 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).
Time Frame Prenaprosyn Baseline, Postnaprosyn Baseline, Week 1, Week 2 week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eszopiclone Placebo
Hide Arm/Group Description:
Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
Placebo : Placebo nightly over duration of double blind study phase.
Overall Number of Participants Analyzed 32 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
Prenaprosyn Baseline 18.85  (4.01) 20.26  (4.07)
Postnaprosyn baseline 18.00  (3.41) 16.78  (4.32)
Week 1 11.28  (6.10) 12.85  (5.97)
Week 2 10.61  (6.60) 12.74  (6.39)
Week 4 8.38  (6.42) 13.75  (6.78)
8.Secondary Outcome
Title Patient Global Impression of Pain Ratings
Hide Description Pain ratings included a global impression of pain rating (PGI) (1-5 rating with 1 being little pain and 5 is worst pain)
Time Frame postnaprosyn Baseline, Week 1, Week 2 week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eszopiclone Placebo
Hide Arm/Group Description:
Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
Placebo : Placebo nightly over duration of double blind study phase.
Overall Number of Participants Analyzed 32 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
postnaprosyn Baseline 4.02  (0.95) 3.90  (1.47)
Week 1 3.54  (1.17) 3.82  (1.45)
Week 2 3.30  (1.27) 4.01  (1.12)
Week 4 3.08  (1.28) 3.80  (1.14)
9.Secondary Outcome
Title Roland Morris Low Back Pain Inventory (RMLBPI)
Hide Description

The 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).

Time Frame prenaprosyn baseline, postnaprosyn Baseline, Week 1, Week 2, week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eszopiclone Placebo
Hide Arm/Group Description:
Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
Placebo : Placebo nightly over duration of double blind study phase.
Overall Number of Participants Analyzed 32 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
prenaprosyn Baseline 12.27  (5.70) 11.33  (5.66)
postnaprosyn Baseline 9.97  (5.55) 10.30  (5.75)
Week 1 9.10  (6.37) 9.05  (6.32)
Week 2 7.63  (6.34) 9.32  (6.25)
Week 4 6.59  (5.49) 7.94  (6.99)
10.Secondary Outcome
Title Hamilton Depression Rating Scale (HAM-D-24)
Hide Description The 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.
Time Frame prenaprosyn baseline, postnaprosyn Baseline, Week 1, Week 2, week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Eszopiclone Placebo
Hide Arm/Group Description:
Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
Placebo : Placebo nightly over duration of double blind study phase.
Overall Number of Participants Analyzed 32 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
prenaprosyn Baseline 6.45  (2.26) 7.10  (3.83)
postnaprosyn Baseline 6.38  (2.37) 6.57  (3.63)
Week 1 4.54  (3.71) 5.53  (3.28)
Week 2 4.14  (3.50) 5.07  (3.61)
Week 4 2.62  (2.61) 6.21  (5.18)
11.Secondary Outcome
Title Short Form 36 Health Survey Questionnaire (SF-36)
Hide Description 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).
Time Frame Baseline, week 1, week 2, week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected.
Arm/Group Title Eszopiclone Placebo
Hide Arm/Group Description:
Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
Placebo : Placebo nightly over duration of double blind study phase.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title State-Trait Anxiety Inventory (STAI)
Hide Description Self-rating assessment of anxiety measured by STAI, state anxiety inventory (Scale 40-160, where a lower value shows a larger improvement)
Time Frame Baseline, week 1, week 2, week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected.
Arm/Group Title Eszopiclone Placebo
Hide Arm/Group Description:
Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
Placebo : Placebo nightly over duration of double blind study phase.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Eszopiclone Placebo
Hide Arm/Group Description Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase. Placebo : Placebo nightly over duration of double blind study phase.
All-Cause Mortality
Eszopiclone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Eszopiclone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/25 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Eszopiclone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/25 (0.00%) 
  1. We obtained only self-reported sleep outcomes.
  2. The period of double-blind treatment was relatively short.
  3. We excluded all subjects who might have required opioid therapy to manage their pain which limits study generalizability.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Jenny Bridgers, CRC
Organization: Duke University
Phone: 919-684-0752
Publications:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00365976     History of Changes
Other Study ID Numbers: Pro00011697
ESRC 032
First Submitted: August 16, 2006
First Posted: August 18, 2006
Results First Submitted: March 19, 2013
Results First Posted: June 7, 2013
Last Update Posted: July 24, 2015