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

February 16, 2011
December 21, 2011
June 2010
September 2010   (final data collection date for primary outcome measure)
Overall Satisfaction Degree After 2 Weeks Treatment of Triple Therapy (MBL+MYO+NSAID). [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
The measurement of overall satisfaction degree was in three scales, that was satisfactory, just so so and dissatisfactory. The measurement was estimated by both the physicians and the patients respectively.
Overall satisfaction degree after 2 weeks of triple therapy. [ Time Frame: 2 weeks. ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01299077 on ClinicalTrials.gov Archive Site
  • Onset Time of Symptom Relief. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Kaplan-Meier Estimates for the Average Onset Time of Symptom Relief. In this case the onset time of symptom relief was defined as the days between the end of triple therapy and the symptom improvement reported by patients.
  • Safety Data During Triple Therapy. [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
    Percentage of participants with reported Adverse Events (AE) and Serious Adverse Event (SAE)
  • Japanese Orthopedic Association (JOA) Score [ Time Frame: Baseline and 2 weeks ] [ Designated as safety issue: No ]

    Each patient is Scored on JOA at baseline and two weeks. JOA is short for Japanese Orthopedic Association, which consists of 12 items: low back pain, lower extremity pain and numbness, walking ability, straight leg raising, muscle strength, sensory and etc. The first 3 item's scores are range from 0 to 3 and the others are from 0 to 2. Higher score means better condition.

    All of these items scores are combined for a total overall JOA score, which is range from 0 to 27.

  • Visual Analogue Scale (VAS) Score [ Time Frame: Baseline and 2 weeks ] [ Designated as safety issue: No ]
    Each patient is Scored on VAS at baseline and two weeks. VAS is the abbreviation of visual analogue score. There is no subscale in VAS. The maximum value of vas is 10 and the minimum is 0. This is self-evaluation method to present the severity of patient pain. More score number, more pain.
  • Onset time of symptom relief. [ Time Frame: 2 weeks. ] [ Designated as safety issue: Yes ]
  • Safety data during triple therapy. [ Time Frame: 2 weeks. ] [ Designated as safety issue: Yes ]
  • Change of Japanese Orthopedic Association (JOA) score before and after triple therapy. [ Time Frame: 2 weeks. ] [ Designated as safety issue: Yes ]
  • Change of Visual Analogue Scale (VAS) score before and after triple therapy. [ Time Frame: 2 weeks. ] [ Designated as safety issue: Yes ]
Not Provided
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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
A Retrospective Drug Use Survey (DUS) of Triple Therapy (Methycobal (MBL)+ Myonal (MYO)+ Non-steroidal Anti-inflammatory Drags (NSAID)) on the Symptom Relief of Lumbar Disc Degenerative Disease in China

The purpose of this study is to observe the overall satisfaction of patients with degenerative disc disease after receiving triple therapy.

DDD (lumbar disc degenerative disease ) patients who have been prescribed triple therapy (MBL+ MYO+ NSAIDs) over 2 weeks of triple therapy were enrolled in the study. They were asked to assess their overall satisfaction degree on triple therapy.

Observational
Observational Model: Case-Only
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

outpatients visited to the clinics with lumbar disc degenerative disease

Lumbar Disc Degenerative Disease
Not Provided
Lumbar disc degenerative disease
Triple therapy (MBL+ MYO+ NSAIDs) which prescribed by doctors (Drs) based on disease condition
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
478
November 2010
September 2010   (final data collection date for primary outcome measure)

Inclusion criteria:

  1. lumbar degenerative disc disease (DDD)
  2. patients who have been prescribed over 2 weeks of triple therapy

Exclusion criteria:

Patients who do not meet inclusion criteria for DDD

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01299077
EISAI-MBL-2010-1
No
Eisai Inc. ( Eisai China Inc. )
Eisai China Inc.
Not Provided
Study Director: Haibo Song Eisai China Inc.
Eisai Inc.
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP