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

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: September 2010

Detailed Description

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.

Arms, Groups and Cohorts

  • Lumbar disc degenerative disease
    • Triple therapy (MBL+ MYO+ NSAIDs) which prescribed by doctors (Drs) based on disease condition

Clinical Trial Outcome Measures

Primary Measures

  • Overall Satisfaction Degree After 2 Weeks Treatment of Triple Therapy (MBL+MYO+NSAID).
    • Time Frame: 2 weeks
    • 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.

Secondary Measures

  • Onset Time of Symptom Relief.
    • Time Frame: 2 weeks
    • 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
    • Percentage of participants with reported Adverse Events (AE) and Serious Adverse Event (SAE)
  • Japanese Orthopedic Association (JOA) Score
    • Time Frame: Baseline and 2 weeks
    • 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
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Eisai China Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Haibo Song, Study Director, Eisai China Inc.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.