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Study To Assess The Reproducibility And Sensitivity Of Quantitative Sensory Testing In Patients With Neuropathic Pain

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01117766
First received: May 4, 2010
Last updated: February 14, 2011
Last verified: February 2011
History of Changes
Results First Received: September 1, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator)
Condition: Neuropathic Pain
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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Pregabalin Then Placebo During the 4-week pregabalin treatment period, participants were titrated up to 300 mg twice daily (BID) for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later. Then after a 2-week washout period, participants took placebo to match the pregabalin doses BID during a 4-week treatment period.
Placebo Then Pregabalin Participants took placebo to match the pregabalin doses BID during the first 4- week treatment period. Then after a 2-week washout period, participants were titrated up to 300 mg pregabalin BID for the first 2 weeks and then remained at 300 mg BID for the duration of the second 4-week treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.

Participant Flow for 3 periods

 Period 1:   First Intervention
    Pregabalin Then Placebo     Placebo Then Pregabalin  
STARTED     14     17  
Received Treatment     14     17  
COMPLETED     13     16  
NOT COMPLETED     1     1  
Adverse Event                 0                 1  
Unspecified                 0                 0  
Protocol Violation                 1                 0  

Period 2:   Washout Period
    Pregabalin Then Placebo     Placebo Then Pregabalin  
STARTED     13     16  
COMPLETED     13     14  
NOT COMPLETED     0     2  
Protocol Violation                 0                 2  

Period 3:   Second Intervention
    Pregabalin Then Placebo     Placebo Then Pregabalin  
STARTED     13     14  
COMPLETED     11     9  
NOT COMPLETED     2     5  
Lost to Follow-up                 1                 0  
Unspecified                 1                 2  
Adverse Event                 0                 2  
Withdrawal by Subject                 0                 1  



  Baseline Characteristics
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Reporting Groups
  Description
All Participants Includes all participants randomized to receive pregabalin first and placebo first.

Baseline Measures
    All Participants  
Number of Participants  
[units: participants]
 		  31  
Age, Customized  
[units: participants]
 		 
18 to 44 years     9  
45 to 64 years     12  
>=65 years     10  
Gender  
[units: participants]
 		 
Female     18  
Male     13  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Change From Baseline in Dynamic Allodynia Intensity at Visits 3 and 6 and Visits 4 and 7   [ Time Frame: Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period ]
  Show Outcome Measure 1

2.  Primary:   Mean Change From Baseline in Dynamic Allodynia Area at Visits 3 and 6 and Visits 4 and 7   [ Time Frame: Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period ]
  Show Outcome Measure 2

3.  Primary:   Mean Change From Baseline in Mechanical Pain Sensitivity (Von Frey) at Visits 3 and 6 and Visits 4 and 7   [ Time Frame: Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period ]
  Show Outcome Measure 3

4.  Primary:   Mean Change From Baseline in Punctate Allodynia Area (Von Frey) at Visits 3 and 6 and Visits 4 and 7   [ Time Frame: Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period ]
  Show Outcome Measure 4

5.  Primary:   Mean Change From Baseline in Cold Pain Sensitivity at Visits 3 and 6 and Visits 4 and 7   [ Time Frame: Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period ]
  Show Outcome Measure 5

6.  Primary:   Mean Change From Baseline in Heat Pain Sensitivity at Visits 3 and 6 and Visits 4 and 7   [ Time Frame: Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period ]
  Show Outcome Measure 6

7.  Secondary:   Mean Change From Baseline in Weekly Pain Score From the Daily Diary at Visits 3 and 6 and Visits 4 and 7   [ Time Frame: Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period ]
  Show Outcome Measure 7

8.  Secondary:   Mean Change From Baseline in Patient's Global Impression of Change (PGIC) at Visits 3 and 6 and Visits 4 and 7   [ Time Frame: Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period ]
  Show Outcome Measure 8

9.  Secondary:   Mean Change From Baseline in Test-Day Global Pain Intensity at Visits 3 and 6 and Visits 4 and 7   [ Time Frame: Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period ]
  Show Outcome Measure 9

10.  Secondary:   Mean Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Total Score at Visits 4 and 7   [ Time Frame: Week 4 (Visits 4 and 7) of each period ]
  Show Outcome Measure 10


  Serious Adverse Events
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  Other Adverse Events
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  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
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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: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01117766     History of Changes
Other Study ID Numbers: A9011015
Study First Received: May 4, 2010
Results First Received: September 1, 2010
Last Updated: February 14, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency