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
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Purpose
The purpose of this study is to observe the overall satisfaction of patients with degenerative disc disease after receiving triple therapy.
| Condition |
|---|
|
Lumbar Disc Degenerative Disease |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Retrospective |
| 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 |
- 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.
- 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.
| Enrollment: | 478 |
| Study Start Date: | June 2010 |
| Study Completion Date: | November 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Lumbar disc degenerative disease
Triple therapy (MBL+ MYO+ NSAIDs) which prescribed by doctors (Drs) based on disease condition
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
outpatients visited to the clinics with lumbar disc degenerative disease
Inclusion criteria:
- lumbar degenerative disc disease (DDD)
- patients who have been prescribed over 2 weeks of triple therapy
Exclusion criteria:
Patients who do not meet inclusion criteria for DDD
Contacts and Locations| China, Shanghai | |
| Huashan Hospital | |
| Shanghai, Shanghai, China | |
| Zhongshan Hospital | |
| Shanghai, Shanghai, China | |
| Ruijin Hospital | |
| Shanghai, Shanghai, China | |
| Xinhua Hospital | |
| Shanghai, Shanghai, China | |
| Dongfang Hospital | |
| Shanghai, Shanghai, China | |
| China, Zhejiang | |
| The 1st Hospital of Zhejiang University | |
| Hanzhou, Zhejiang, China | |
| The 2nd Hospital of Zhejiang University | |
| Hanzhou, Zhejiang, China | |
| Shao Yifu Hospital of Zhejiang University | |
| Hanzhou, Zhejiang, China | |
| Traditional Chinese Medicine Hospital of Zhejiang | |
| Hanzhou, Zhejiang, China | |
| The 1st People Hospital of Hanzhou | |
| Hanzhou, Zhejiang, China | |
| Study Director: | Haibo Song | Eisai China Inc. |
More Information
No publications provided
| Responsible Party: | Eisai Inc. ( Eisai China Inc. ) |
| ClinicalTrials.gov Identifier: | NCT01299077 History of Changes |
| Other Study ID Numbers: | EISAI-MBL-2010-1 |
| Study First Received: | February 16, 2011 |
| Results First Received: | August 16, 2011 |
| Last Updated: | December 21, 2011 |
| Health Authority: | China: No Health Authority |
Keywords provided by Eisai Inc.:
|
Lumbar disc degenerative disease Methycobal |
Additional relevant MeSH terms:
|
Intervertebral Disk Degeneration Spinal Diseases Bone Diseases Musculoskeletal Diseases Anti-Inflammatory Agents Anti-Inflammatory Agents, Non-Steroidal Therapeutic Uses |
Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 19, 2013