Drug Use Survey (DUS) of Triple Therapy (Methycobal (MBL)+ Myonal (MYO)+ Non-steroidal Anti-inflammatory Drags (NSAID)) on the Symptom Relief of Lumbar DDD in China

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai China Inc. )
ClinicalTrials.gov Identifier:
NCT01299077
First received: February 16, 2011
Last updated: December 21, 2011
Last verified: May 2011
Results First Received: August 16, 2011  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Retrospective
Condition: Lumbar Disc Degenerative Disease

  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
This study was recruited at 10 centers in China during the period of 09-Jun-2010 to 28-Sept-2010 .

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Lumbar Disc Degenerative Disease

Triple therapy ( Methycobal (MBL) + Myonal (MYO) + non-steroidal anti-inflammatory drugs (NSAIDs)) which prescribed by doctors (Drs) based on disease condition. MBL 0.5 mg : three times daily for two weeks, MYO 50 mg : three times daily for two weeks:

NSAID (diclofenac) 75 mg,: twice daily for two weeks


Participant Flow:   Overall Study
    Lumbar Disc Degenerative Disease  
STARTED     478  
COMPLETED     478  
NOT COMPLETED     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.
No text entered.

Reporting Groups
  Description
Lumbar Disc Degenerative Disease

Triple therapy ( Methycobal (MBL) + Myonal (MYO) + non-steroidal anti-inflammatory drugs (NSAIDs)) which prescribed by doctors (Drs) based on disease condition. MBL 0.5 mg : three times daily for two weeks, MYO 50 mg : three times daily for two weeks:

NSAID (diclofenac) 75 mg,: twice daily for two weeks


Baseline Measures
    Lumbar Disc Degenerative Disease  
Number of Participants  
[units: participants]
  478  
Age  
[units: years]
Mean ± Standard Deviation
  50.34  ± 12.63  
Gender  
[units: participants]
 
Female     252  
Male     226  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     478  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     0  
White     0  
More than one race     0  
Unknown or Not Reported     0  



  Outcome Measures
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1.  Primary:   Overall Satisfaction Degree After 2 Weeks Treatment of Triple Therapy (MBL+MYO+NSAID).   [ Time Frame: 2 weeks ]

2.  Secondary:   Onset Time of Symptom Relief.   [ Time Frame: 2 weeks ]

3.  Secondary:   Safety Data During Triple Therapy.   [ Time Frame: 2 weeks ]

4.  Secondary:   Japanese Orthopedic Association (JOA) Score   [ Time Frame: Baseline and 2 weeks ]

5.  Secondary:   Visual Analogue Scale (VAS) Score   [ Time Frame: Baseline and 2 weeks ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Haibo Song
Organization: Eisai China Inc.
phone: 0086-21-24192864
e-mail: songhaibo@eisai.com.cn


No publications provided


Responsible Party: Eisai Inc. ( Eisai China Inc. )
ClinicalTrials.gov Identifier: NCT01299077     History of Changes
Other Study ID Numbers: EISAI-MBL-2010-1
Study First Received: February 16, 2011
Results First Received: August 16, 2011
Last Updated: December 21, 2011
Health Authority: China: No Health Authority