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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

Completed
Conditions
Lumbar Disc Degenerative Disease
Registration Number
NCT01299077
Lead Sponsor
Eisai China Inc.
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
478
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Overall Satisfaction Degree After 2 Weeks Treatment of Triple Therapy (MBL+MYO+NSAID).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 Outcome Measures
NameTimeMethod
Safety Data During Triple Therapy.2 weeks

Percentage of participants with reported Adverse Events (AE) and Serious Adverse Event (SAE)

Onset Time of Symptom Relief.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.

Japanese Orthopedic Association (JOA) ScoreBaseline 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) ScoreBaseline 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.

Trial Locations

Locations (10)

Dongfang Hospital

🇨🇳

Shanghai, Shanghai, China

Ruijin Hospital

🇨🇳

Shanghai, Shanghai, China

Xinhua Hospital

🇨🇳

Shanghai, Shanghai, China

Huashan Hospital

🇨🇳

Shanghai, Shanghai, China

Zhongshan Hospital

🇨🇳

Shanghai, Shanghai, 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

🇨🇳

Hanzhou, Zhejiang, China

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