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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00830167
First received: January 26, 2009
Last updated: April 30, 2012
Last verified: April 2012
Results First Received: April 30, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Fibromyalgia
Interventions: Drug: Placebo
Drug: Pregabalin

  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
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
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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
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  
Number of Participants  
[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
  Show All 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 ]

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 ]

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

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

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 ]

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 ]

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

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

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 ]

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

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

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

Measure Type Secondary
Measure Title Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Total Scores
Measure Description FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline.
Time Frame Baseline, Week 15 or study discontinuation  
Safety Issue No  

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  
Number of Participants Analyzed  
[units: participants]
  248     250  
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Total Scores  
[units: Scores on a scale]
Least Squares Mean ± Standard Error
  -7.26  ± 1.08     -10.59  ± 1.07  


Statistical Analysis 1 for Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) at Endpoint - Total Scores
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.0144
Mean Difference (Final Values) [4] -3.33
Standard Error of the mean ± 1.52
95% Confidence Interval ( -6.31 to -0.35 )
[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] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] 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.
[4] Other relevant estimation information:
  No text entered.



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

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

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

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

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

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

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

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

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

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

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 ]

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 ]

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 ]

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 ]
  Hide Outcome Measure 26

Measure Type Secondary
Measure Title Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- General Health Perception
Measure Description Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline.
Time Frame Baseline, Week 15 or study discontinuation  
Safety Issue No  

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  
Number of Participants Analyzed  
[units: participants]
  248     250  
Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- General Health Perception  
[units: Scores on a scale]
Least Squares Mean ± Standard Error
  2.83  ± 0.85     4.66  ± 0.85  


Statistical Analysis 1 for Change From Baseline in Analysis of SF-36 Health Survey Results at Endpoint- General Health Perception
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.0648
Mean Difference (Final Values) [4] 1.83
Standard Error of the mean ± 1.20
95% Confidence Interval ( -0.54 to 4.19 )
[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] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] 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.
[4] Other relevant estimation information:
  No text entered.



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 ]

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 ]

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

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 ]

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

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

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


  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
No text entered.  


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


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00830167     History of Changes
Other Study ID Numbers: A0081208
Study First Received: January 26, 2009
Results First Received: April 30, 2012
Last Updated: April 30, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare