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.

Study Overview

• Status: Completed
• Conditions: Lumbar Disc Degenerative Disease

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.

• Study Type: Observational
• Enrollment (Actual): 478

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Zhongshan Hospital
    • Shanghai, Shanghai, China
      • Huashan Hospital
    • Shanghai, Shanghai, China
      • Ruijin Hospital
    • Shanghai, Shanghai, China
      • Dongfang Hospital
    • Shanghai, Shanghai, China
      • Xinhua Hospital
  • Zhejiang
    • Hanzhou, Zhejiang, China
      • Shao Yifu Hospital of Zhejiang University
    • Hanzhou, Zhejiang, China
      • The 1st Hospital of Zhejiang University
    • Hanzhou, Zhejiang, China
      • The 1st People Hospital of Hanzhou
    • Hanzhou, Zhejiang, China
      • The 2nd Hospital of Zhejiang University
    • Hanzhou, Zhejiang, China
      • Traditional Chinese Medicine Hospital of Zhejiang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

outpatients visited to the clinics with lumbar disc degenerative disease

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Onset Time of Symptom Relief.	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.	2 weeks
Safety Data During Triple Therapy.	Percentage of participants with reported Adverse Events (AE) and Serious Adverse Event (SAE)	2 weeks
Japanese Orthopedic Association (JOA) Score	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.	Baseline and 2 weeks
Visual Analogue Scale (VAS) Score	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.	Baseline and 2 weeks

Collaborators and Investigators

• Sponsor: Eisai China Inc.
• Investigators: Study Director: Haibo Song, Eisai China Inc.

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: February 16, 2011
• First Submitted That Met QC Criteria: February 17, 2011
• First Posted (Estimate): February 18, 2011

Study Record Updates

• Last Update Posted (Estimate): December 28, 2011
• Last Update Submitted That Met QC Criteria: December 21, 2011
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Keywords: Lumbar disc degenerative disease; Methycobal
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Intervertebral Disc Degeneration
• Other Study ID Numbers: EISAI-MBL-2010-1