Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

An fMRI Study Of Brain Response In Patients With Fibromyalgia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00760474
First received: September 25, 2008
Last updated: June 22, 2012
Last verified: June 2012
Results First Received: March 7, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Condition: Fibromyalgia
Interventions: Drug: Pregabalin, then placebo
Drug: Placebo, then pregabalin

  Participant Flow
  Hide 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 who met entrance criteria received placebo for 1 week (Day 1 to 8) then were randomized in a 1:1 ratio to blinded treatment sequence.

Reporting Groups
  Description
Pregabalin First, Then Placebo Pregabalin 75 milligrams (mg) by mouth (PO) twice daily (BID) Period 1/Day 9 to 11; 150 mg BID Day 12 to 16; 200 mg BID Day 17 to 19; 225 mg BID Day 20 to 22 followed by taper Day 23 to 29 and an 8-day placebo washout period. Then, placebo matching study treatment in a similar pattern was administered beginning Period 2/Day 38.
Placebo First, Then Pregabalin Placebo matching study treatment was administered beginning Period 1/Day9. Then, Pregabalin 75 mg BID Period 2/Day 38 to 40; 150 mg BID Day 41 to 45; 200 mg BID Day 46 to 48; 225 mg BID Day 49 to 51 followed by placebo taper Day 52 to 58.

Participant Flow for 3 periods

Period 1:   Period 1 (P1)
    Pregabalin First, Then Placebo     Placebo First, Then Pregabalin  
STARTED     13     14  
Treated     13 [1]   14 [1]
Overall Number of Unique Participants     12     13  
COMPLETED     12     13  
NOT COMPLETED     1     1  
Discontinued then re-entered                 1                 1  
[1] 1 participant discontinued in P1; re-entered with new identification number and completed P1, P2.

Period 2:   Placebo Washout Period
    Pregabalin First, Then Placebo     Placebo First, Then Pregabalin  
STARTED     12     13  
COMPLETED     12     12  
NOT COMPLETED     0     1  
Unspecified                 0                 1  

Period 3:   Period 2 (P2)
    Pregabalin First, Then Placebo     Placebo First, Then Pregabalin  
STARTED     12     12  
COMPLETED     11     11  
NOT COMPLETED     1     1  
Lost to Follow-up                 1                 0  
Adverse Event                 0                 1  



  Baseline Characteristics
  Hide 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
Entire Study Population

Participants who met entrance criteria received placebo for 1 week (Day 1 to 8) then were randomized in a 1:1 ratio to blinded treatment sequence to receive either:

Pregabalin, then placebo: Pregabalin 75 mg PO BID Period 1/Day 9 to 11; 150 mg BID Day 12 to 16; 200 mg BID Day 17 to 19; 225 mg BID Day 20 to 22 followed by taper Day 23 to 29 and an 8-day placebo washout period. Then, placebo matching study treatment in a similar pattern was administered beginning Period 2/Day 38 and included dose escalation through Day 51 followed by placebo taper Day 52 to 58.

Or placebo, then Pregabalin: Placebo matching study treatment was administered in a similar fashion to Pregabalin treatment beginning Period 1/Day 9 and included dose escalation, taper and an 8-day placebo washout period. Then, Pregabalin 75 mg BID Period 2/Day 38 to 40; 150 mg BID Day 41 to 45; 200 mg BID Day 46 to 48; 225 mg BID Day 49 to 51 followed by placebo taper Day 52 to 58.


Baseline Measures
    Entire Study Population  
Number of Participants  
[units: participants]
  25  
Age  
[units: years]
Mean ± Standard Deviation
  38.6  ± 12.0  
Gender, Customized [1]
[units: participants]
  25  
[1] Female



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Glutamine/Creatine (Gln/Cr) and Glutamate/Creatine (Glu/Cr) Ratios Measured by Proton Magnetic Resonance Spectroscopy (1H-MRS)   [ Time Frame: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) ]

2.  Primary:   Voxel-wise Blood Oxygen Level Dependent (BOLD) Using Functional Magnetic Resonance Imaging (fMRI) of Brain Activation Signals in Response to Blunt Pressure Pain: Percent Change in BOLD Activations Including Outliers   [ Time Frame: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) ]

3.  Secondary:   Voxel-wise Blood Oxygen Level Dependent (BOLD) Using Functional Magnetic Resonance Imaging (fMRI) of Brain Activation Signals in Response to a Control Visual (Checkerboard) Stimuli   [ Time Frame: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) ]

4.  Secondary:   Resting State Brain Activity (Connectivity Analysis) Assessed by Temporal Correlations in Low Frequency fMRI BOLD Signals Across Pain Processing Regions   [ Time Frame: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) ]

5.  Secondary:   Gracely Box Scales for Pain Intensity (GBSint) Including Outliers   [ Time Frame: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) ]

6.  Secondary:   Gracely Box Scales for Pain Unpleasantness (GBSunp) Including Outliers   [ Time Frame: Baseline/Pre-dose (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) ]

7.  Secondary:   Daily Pain Diary Numeric Rating Scale (NRS) Item From the Modified Brief Pain Inventory (mBPI) for Assessment of Clinical Pain: 7 Day Average Pain Score Including Outliers   [ Time Frame: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) ]

8.  Secondary:   Daily Pain Diary Numeric Rating Scale (NRS) Item From the Modified Brief Pain Inventory (mBPI) for Assessment of Clinical Pain: 3 Day Average Pain Score Including Outliers   [ Time Frame: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) ]

9.  Secondary:   Daily Pain Diary Numeric Rating Scale (NRS) Item From the Modified Brief Pain Inventory (mBPI) for Assessment of Clinical Pain: Individual Daily Pain Score Including Outliers   [ Time Frame: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) ]

10.  Secondary:   Short-Form McGill Pain Questionnaire (SF-MPQ): Affective Total Score Including Outliers   [ Time Frame: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) ]

11.  Secondary:   Short-Form McGill Pain Questionnaire (SF-MPQ): Sensory Total Score Including Outliers   [ Time Frame: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) ]

12.  Secondary:   Short-Form McGill Pain Questionnaire (SF-MPQ): Overall Score Including Outliers   [ Time Frame: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) ]

13.  Secondary:   Sphygmomanometry Evoked Allodynia in Relation to the Blood Pressure (BP) Value at Which Allodynia Was Evoked   [ Time Frame: Day 58 ]

14.  Secondary:   Pain at the Bilateral Epicondyle Tender Points Assessed Using American College of Rheumatology (ACR) Classification Criteria   [ Time Frame: Day 58 ]

15.  Other Pre-specified:   Hospital Anxiety and Depression Scale (HADS): Anxiety Total Score Including Outliers   [ Time Frame: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) ]

16.  Other Pre-specified:   Hospital Anxiety and Depression Scale (HADS): Depression Total Score Including Outliers   [ Time Frame: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) ]

17.  Other Pre-specified:   Pain Catastrophizing Scale (PCS) Including Outliers   [ Time Frame: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
  Hide More Information

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.


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


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00760474     History of Changes
Other Study ID Numbers: A0081211
Study First Received: September 25, 2008
Results First Received: March 7, 2012
Last Updated: June 22, 2012
Health Authority: United States: Food and Drug Administration