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The Impact of SCN9A Gene Polymorphism on Individual Pain Perception in the General Population

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Xianwei Zhang, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01507493
First received: January 2, 2012
Last updated: August 31, 2014
Last verified: August 2014
Results First Received: May 30, 2013  
Study Type: Observational
Conditions: Pain
Surgery

  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
Mutant Alleles grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.
Wild-type Alleles grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.

Participant Flow:   Overall Study
    Mutant Alleles     Wild-type Alleles  
STARTED     22     178  
COMPLETED     22     178  
NOT COMPLETED     0     0  



  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.
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Reporting Groups
  Description
Mutant Alleles grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.
Wild-type Alleles grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.
Total Total of all reporting groups

Baseline Measures
    Mutant Alleles     Wild-type Alleles     Total  
Number of Participants  
[units: participants]
  22     178     200  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     22     162     184  
>=65 years     0     16     16  
Age  
[units: years]
Mean ± Standard Deviation
  51.9  ± 9.3     55.6  ± 5.3     55.2  ± 5.7  
Gender  
[units: participants]
     
Female     12     101     113  
Male     10     77     87  
Region of Enrollment  
[units: participants]
     
China     22     178     200  



  Outcome Measures
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1.  Primary:   Opioid Consumption Dose 48h After Operation.   [ Time Frame: 48 hours after the operation ]

2.  Primary:   PCA Press Frequency 48h After Operation.   [ Time Frame: 48 hours after the operation ]

3.  Secondary:   The Visual Analog Scale 48h After Operation.   [ Time Frame: 48 hours after the operation ]

4.  Secondary:   Preoperative Pressure Pain Threshold (PPT)   [ Time Frame: 12 hours before the operation ]

5.  Secondary:   Preoperative Pressure Pain Tolerance (PTO)   [ Time Frame: 12 hours before the operation ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Xianwei Zhang
Organization: Huazhong University of Science&Technology
phone: 13037154560
e-mail: znpain@sina.com


No publications provided


Responsible Party: Xianwei Zhang, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT01507493     History of Changes
Other Study ID Numbers: SCN9A
Study First Received: January 2, 2012
Results First Received: May 30, 2013
Last Updated: August 31, 2014
Health Authority: China: Food and Drug Administration