Lumbar Disc Degenerative Disease Clinical Trial
Official title:
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
| Verified date | May 2011 |
| Source | Eisai Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | China: No Health Authority |
| Study type | Observational |
The purpose of this study is to observe the overall satisfaction of patients with degenerative disc disease after receiving triple therapy.
| Status | Completed |
| Enrollment | 478 |
| Est. completion date | November 2010 |
| Est. primary completion date | September 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Observational Model: Case-Only, Time Perspective: Retrospective
| Country | Name | City | State |
|---|---|---|---|
| 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 | Dongfang Hospital | Shanghai | Shanghai |
| China | Huashan Hospital | Shanghai | Shanghai |
| China | Ruijin Hospital | Shanghai | Shanghai |
| China | Xinhua Hospital | Shanghai | Shanghai |
| China | Zhongshan Hospital | Shanghai | Shanghai |
| Lead Sponsor | Collaborator |
|---|---|
| Eisai China Inc. |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | 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 | No |
| Secondary | Safety Data During Triple Therapy. | Percentage of participants with reported Adverse Events (AE) and Serious Adverse Event (SAE) | 2 weeks | Yes |
| Secondary | 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 | No |
| Secondary | 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 | No |