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Randomized, Double-Blind, Placebo-Controlled Study Of Pregabalin In Patients With Fibromyalgia

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ClinicalTrials.gov Identifier: NCT00830167
Recruitment Status : Completed
First Posted : January 27, 2009
Results First Posted : June 1, 2012
Last Update Posted : June 1, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Fibromyalgia
Interventions: Drug: Placebo
Drug: Pregabalin

  Participant Flow

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
Participants were administered placebo tablet in single blind manner and evaluated for the inclusion/exclusion criteria during the 1-week screening phase. Participants who demonstrated a high response to placebo, i.e., <=30% decrease on the VAS, were discontinued from the study at the end of the screening phase.

Reporting Groups
  Description
Placebo Placebo was administered twice a day for 15 weeks.
Pregabalin Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.

Participant Flow:   Overall Study
    Placebo   Pregabalin
STARTED   248 [1]   250 [1] 
COMPLETED   208   207 
NOT COMPLETED   40   43 
Lack of Efficacy                26                10 
Adverse Event                8                24 
Not meeting entrance criteria                2                5 
Withdrawal by Subject                2                0 
Lost to Follow-up                0                1 
Protocol Violation                0                1 
Other                2                2 
[1] Treated



  Baseline Characteristics

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
Placebo Placebo was administered twice a day for 15 weeks.
Pregabalin Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
Total Total of all reporting groups

Baseline Measures
   Placebo   Pregabalin   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 248   250   498 
Age, Customized 
[Units: Participants]
 		     
<18 years   0   0   0 
Between 18 years and 44 years   104   101   205 
Between 45 years and 64 years   123   125   248 
>=65 years   21   24   45 
Gender 
[Units: Participants]
 		     
Female   217   226   443 
Male   31   24   55 


  Outcome Measures

1.  Primary:   Change From Baseline for Numerical Rating Scale (NRS) Pain Scores at Endpoint-LOCF (Last Observation Carried Forward) Relative to Baseline   [ Time Frame: Baseline, Week 15 or study discontinuation ]
  Show Outcome Measure 1

2.  Secondary:   Percentage of Participants Who Was Categorized as “Improved (Very Much Improved, Much Improved, or a Minimally Improved)” According to the Patient Global Impressions of Change (PGIC)   [ Time Frame: Week 15 or study discontinuation ]
  Show Outcome Measure 2

3.  Secondary:   Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Sleep Disturbance   [ Time Frame: Baseline, Week 15 or study discontinuation ]
  Show Outcome Measure 3

4.  Secondary:   Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Snoring   [ Time Frame: Baseline, Week 15 or study discontinuation ]
  Show Outcome Measure 4

5.  Secondary:   Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Awaken Short of Breath or With a Headache   [ Time Frame: Baseline, Week 15 or study discontinuation ]
  Show Outcome Measure 5

6.  Secondary:   Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Quantity of Sleep   [ Time Frame: Baseline, Week 15 or study discontinuation ]
  Show Outcome Measure 6

7.  Secondary:   Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Sleep Adequacy   [ Time Frame: Baseline, Week 15 or study discontinuation ]
  Show Outcome Measure 7

8.  Secondary:   Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Somnolence   [ Time Frame: Baseline, Week 15 or study discontinuation ]
  Show Outcome Measure 8

9.  Secondary:   Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Endpoint- Overall Sleep Problems Index   [ Time Frame: Baseline, Week 15 or study discontinuation ]
  Show Outcome Measure 9

10.  Secondary:   Medical Outcomes Study (MOS) Sleep Scale - Number of Participants With Optimal Sleep at Endpoint   [ Time Frame: Week 15 or study discontinuation ]
  Show Outcome Measure 10

11.  Secondary:   Change From Baseline in Sleep Quality Score at Endpoint   [ Time Frame: Baseline, Week 15 or study discontinuation ]
  Hide Outcome Measure 11

Measure Type Secondary
Measure Title Change From Baseline in Sleep Quality Score at Endpoint
Measure Description Change: Mean sleep quality score at endpoint minus mean at baseline. Sleep quality scores range from 0-10 with higher scores indicating decreased sleep quality.
Time Frame Baseline, Week 15 or study discontinuation  

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.
The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study medication and had at least 1 postbaseline pain score on study medication. Last observation carried forward (LOCF) method was used.

Reporting Groups
  Description
Placebo Placebo was administered twice a day for 15 weeks.
Pregabalin Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.

Measured Values
   Placebo   Pregabalin 
Participants Analyzed 
[Units: Participants]
 		 248   250 
Change From Baseline in Sleep Quality Score at Endpoint 
[Units: Scores on a scale]
Least Squares Mean (Standard Error) 		 -0.79  (0.12)   -1.52  (0.12) 


Statistical Analysis 1 for Change From Baseline in Sleep Quality Score at Endpoint
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] ANCOVA
P Value [4] <0.0001
Mean Difference (Final Values) [5] -0.73
95% Confidence Interval -1.06 to -0.40
Standard Error of the mean (0.17)
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  The analysis was conducted using 1-sided test with the significance level of 0.025.
[5] Other relevant estimation information:
  No text entered.



12.  Secondary:   Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Total Scores   [ Time Frame: Baseline, Week 15 or study discontinuation ]
  Show Outcome Measure 12

13.  Secondary:   Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Physical Function   [ Time Frame: Baseline, Week 15 or study discontinuation ]
  Show Outcome Measure 13

14.  Secondary:   Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Feel Good   [ Time Frame: Baseline, Week 15 or study discontinuation ]
  Show Outcome Measure 14

15.  Secondary:   Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Work Miss   [ Time Frame: Baseline, Week 15 or study discontinuation ]
  Show Outcome Measure 15

16.  Secondary:   Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Housework   [ Time Frame: Baseline, Week 15 or study discontinuation ]
  Show Outcome Measure 16

17.  Secondary:   Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Pain   [ Time Frame: Baseline, Week 15 or study discontinuation ]
  Show Outcome Measure 17

18.  Secondary:   Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Tiredness   [ Time Frame: Baseline, Week 15 or study discontinuation ]
  Show Outcome Measure 18

19.  Secondary:   Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Morning   [ Time Frame: Baseline, Week 15 or study discontinuation ]
  Show Outcome Measure 19

20.  Secondary:   Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Stiffness   [ Time Frame: Baseline, Week 15 or study discontinuation ]
  Show Outcome Measure 20

21.  Secondary:   Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Anxious   [ Time Frame: Baseline, Week 15 or study discontinuation ]
  Show Outcome Measure 21

22.  Secondary:   Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Depression   [ Time Frame: Baseline, Week 15 or study discontinuation ]
  Show Outcome Measure 22

23.  Secondary:   Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Physical Functioning   [ Time Frame: Baseline, Week 15 or study discontinuation ]
  Show Outcome Measure 23

24.  Secondary:   Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Role Limitations-Physical   [ Time Frame: Baseline, Week 15 or study discontinuation ]
  Show Outcome Measure 24

25.  Secondary:   Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Bodily Pain   [ Time Frame: Baseline, Week 15 or study discontinuation ]
  Show Outcome Measure 25

26.  Secondary:   Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- General Health Perception   [ Time Frame: Baseline, Week 15 or study discontinuation ]
  Show Outcome Measure 26

27.  Secondary:   Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Social Functioning   [ Time Frame: Baseline, Week 15 or study discontinuation ]
  Show Outcome Measure 27

28.  Secondary:   Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Role Limitations-Emotional   [ Time Frame: Baseline, Week 15 or study discontinuation ]
  Show Outcome Measure 28

29.  Secondary:   Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Vitality   [ Time Frame: Baseline, Week 15 or study discontinuation ]
  Show Outcome Measure 29

30.  Secondary:   Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- Mental Health   [ Time Frame: Baseline, Week 15 or study discontinuation ]
  Show Outcome Measure 30

31.  Secondary:   Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety   [ Time Frame: Baseline, Week 15 or study discontinuation ]
  Show Outcome Measure 31

32.  Secondary:   Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Depression   [ Time Frame: Baseline, Week 15 or study discontinuation ]
  Show Outcome Measure 32

33.  Secondary:   Change From Baseline in Pain Visual Analog Scale (Pain VAS) Score at Endpoint   [ Time Frame: Baseline, Week 15 or study discontinuation ]
  Show Outcome Measure 33


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.


  More Information