Effects Of Pregabalin (Lyrica) On Sleep Maintenance In Subjects With Fibromyalgia

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00883740
First received: April 17, 2009
Last updated: July 14, 2011
Last verified: July 2011
Results First Received: May 16, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Fibromyalgia
Sleep Disorders
Interventions: Drug: Pregabalin
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo, Then Pregabalin Matching placebo twice daily in first intervention (treatment period 1, weeks 1-4) and pregabalin 75 milligrams (mg) up to 225 mg twice per day in second intervention (treatment period 2, weeks 7-10) after taper and washout period (weeks 5-6).
Pregabalin, Then Placebo Pregabalin 75 mg up to 225 mg twice per day in intervention (treatment period 1, weeks 1-4) and matching placebo twice daily in second intervention (treatment period 2, weeks 7-10) after taper and washout period (weeks 5-6).

Participant Flow for 3 periods

Period 1:   First Intervention
    Placebo, Then Pregabalin     Pregabalin, Then Placebo  
STARTED     60     59  
COMPLETED     53 [1]   51  
NOT COMPLETED     7     8  
Lost to Follow-up                 1                 0  
No longer willing to participate                 2                 0  
Protocol Violation                 3                 6  
Adverse Event                 1                 2  
[1] 1 participant not crossed to period 2 but continued on period 1, sponsor terminated as noncompliance

Period 2:   Taper and Washout Period (2 Weeks)
    Placebo, Then Pregabalin     Pregabalin, Then Placebo  
STARTED     54 [1]   51  
COMPLETED     54     51  
NOT COMPLETED     0     0  
[1] 1 participant not crossed to period 2 but continued on period 1, sponsor terminated as noncompliance

Period 3:   Second Intervention
    Placebo, Then Pregabalin     Pregabalin, Then Placebo  
STARTED     53 [1]   51  
COMPLETED     52     50  
NOT COMPLETED     1     1  
Protocol Violation                 1                 0  
No longer willing to participate                 0                 1  
[1] 1 participant not crossed to period 2 but continued on period 1, sponsor terminated as noncompliance



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Entire Study Population Includes groups randomized to receive matching placebo and Pregabalin, 75 up to 225 mg, twice per day in the first intervention and Pregabalin, 75 up to 225 mg, and matching placebo twice per day in the second intervention

Baseline Measures
    Entire Study Population  
Number of Participants  
[units: participants]
  119  
Age  
[units: Years]
Mean ± Standard Deviation
  48.4  ± 9.9  
Gender  
[units: Participant]
 
Female     103  
Male     16  
Medical Outcome Study Sleep Scale (MOS-SS) Sleep Disturbance Baseline Measure (Weeks 1 and 7) [1]
[units: Scores on a Scale]
Mean ± Standard Deviation
 
Week 1 Sleep Disturbance Placebo     69.32  ± 17.48  
Week 1 Sleep Disturbance Pregabalin     69.29  ± 20.44  
Week 7 Sleep Disturbance Placebo     52.75  ± 24.77  
Week 7 Sleep Disturbance Pregabalin     51.51  ± 26.48  
MOS-SS Overall Sleep Index II Baseline Measure (Weeks 1 and 7) [2]
[units: Scores on a Scale]
Mean ± Standard Deviation
 
Week 1 Sleep Problems Index II Placebo     62.82  ± 12.96  
Week 1 Sleep Problems Index II Pregabalin     63.21  ± 14.27  
Week 7 Sleep Problems Index II Placebo     47.22  ± 18.38  
Week 7 Sleep Problems Index II Pregablin     48.79  ± 19.89  
[1] Sleep Disturbance subscale as measured by MOS-SS, a participant rated 12 item instrument. Baseline intervention period 1 collected at week 1 and baseline intervention period 2 collected at week 7. Scores were transformed and ranged from 0 to 100, higher scores indicated greater disturbance, negative changes indicated improvement.
[2] Overall Sleep Problem Index II determined by a 9 item index that provided a composite measure of overall sleep. Baseline intervention period 1 collected at week 1 and baseline intervention period 2 collected at week 7. Score ranged from 0 to 100, higher scores indicated greater sleep problems, negative changes indicated improvement.



  Outcome Measures
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1.  Primary:   Wake After Sleep Onset (WASO) at Weeks 5 and 11   [ Time Frame: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or Early Termination (ET) ]

2.  Secondary:   Wake Time During Sleep (WTDS)   [ Time Frame: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET ]

3.  Secondary:   Wake Time After Sleep (WTAS)   [ Time Frame: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET ]

4.  Secondary:   Total Sleep Time (TST)   [ Time Frame: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET ]

5.  Secondary:   Sleep Efficiency (SE)   [ Time Frame: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET ]

6.  Secondary:   Number of Awakenings After Sleep Onset (NAASO 1)   [ Time Frame: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET ]

7.  Secondary:   Number of Awakenings After Sleep Onset (NAASO 2)   [ Time Frame: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET ]

8.  Secondary:   Latency to Persistent Sleep (LPS)   [ Time Frame: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET ]

9.  Secondary:   WASO by Hour of the Night   [ Time Frame: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET ]

10.  Secondary:   WASO by Each Quarter of the Night   [ Time Frame: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET ]

11.  Secondary:   Slow Wave Sleep (SWS)   [ Time Frame: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET ]

12.  Secondary:   Change From Baseline in MOS-SS Sleep Disturbance at Weeks 5 and 11   [ Time Frame: Week 1 (Baseline Intervention Period 1), Week 5 (End of Intervention Period 1), Week 7 (Baseline Intervention Period 2) and Week 11 (End of Intervention Period 2) or ET ]

13.  Secondary:   Change From Baseline in MOS-SS Sleep Problems Index II Weeks 5 and 11   [ Time Frame: Week 1 (Baseline Intervention Period 1), Week 5 (End of Intervention Period 1), Week 7 (Baseline Intervention Period 2) and Week 11 (End of Intervention Period 2) or ET ]

14.  Secondary:   Sleep Quality   [ Time Frame: Weeks 1, 2, 3 and 4 of Each Intervention Period or ET ]

15.  Secondary:   Latency of Sleep Onset (LSO)   [ Time Frame: Weeks 1, 2, 3 and 4 of Each Intervention Period or ET ]

16.  Secondary:   Daily Pain Score   [ Time Frame: Daily up to Day 73 or ET ]

17.  Secondary:   Subjective Wake After Sleep Onset (sWASO)   [ Time Frame: Weeks 1, 2, 3 and 4 of Each Intervention Period or ET ]

18.  Secondary:   Subjective Total Sleep Time (sTST)   [ Time Frame: Weeks 1, 2, 3 and 4 of Each Intervention Period or ET ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The protocol specified analyses of secondary outcome measures (OMs) indicated OMs would use PP population; however all secondary OMs were analyzed using the ITT population in accordance with the statistical analysis plan.  


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided by Pfizer

Publications automatically indexed to this study:

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00883740     History of Changes
Other Study ID Numbers: A0081165
Study First Received: April 17, 2009
Results First Received: May 16, 2011
Last Updated: July 14, 2011
Health Authority: United States: Food and Drug Administration