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The purpose of this study is to observe the overall satisfaction of patients with degenerative disc disease after receiving triple therapy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lumbar disc degenerative disease | Triple therapy (MBL+ MYO+ NSAIDs) which prescribed by doctors (Drs) based on disease condition |
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| 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 |
| 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. |
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Inclusion criteria:
Exclusion criteria:
Patients who do not meet inclusion criteria for DDD
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outpatients visited to the clinics with lumbar disc degenerative disease
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| Name | Affiliation | Role |
|---|---|---|
| Haibo Song | Eisai China Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dongfang Hospital | Shanghai | Shanghai Municipality | China | |||
| Huashan Hospital |
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This study was recruited at 10 centers in China during the period of 09-Jun-2010 to 28-Sept-2010 .
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| ID | Title | Description |
|---|---|---|
| FG000 | Lumbar Disc Degenerative Disease | Triple therapy ( Methycobal (MBL) + Myonal (MYO) + non-steroidal anti-inflammatory drugs (NSAIDs)) which prescribed by doctors (Drs) based on disease condition. MBL 0.5 mg : three times daily for two weeks, MYO 50 mg : three times daily for two weeks: NSAID (diclofenac) 75 mg,: twice daily for two weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 |
| Shanghai |
| Shanghai Municipality |
| China |
| Ruijin Hospital | Shanghai | Shanghai Municipality | China |
| Xinhua Hospital | Shanghai | Shanghai Municipality | China |
| Zhongshan Hospital | Shanghai | Shanghai Municipality | 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 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Lumbar Disc Degenerative Disease | Triple therapy ( Methycobal (MBL) + Myonal (MYO) + non-steroidal anti-inflammatory drugs (NSAIDs)) which prescribed by doctors (Drs) based on disease condition. MBL 0.5 mg : three times daily for two weeks, MYO 50 mg : three times daily for two weeks: NSAID (diclofenac) 75 mg,: twice daily for two weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The primary analysis will be on the Per-protocol (PP) population. PP population includes all subjects who received the dose of study drug without protocol deviation and had all the assessment per protocol. | Posted | Number | percentage of participants | 2 weeks |
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| 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. | The primary analysis will be on the Per-protocol (PP) population. PP population includes all subjects who received the dose of study drug without protocol deviation and had all the assessment per protocol. | Posted | Mean | Standard Deviation | Average Days of Onset Time | 2 weeks |
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| Secondary | Safety Data During Triple Therapy. | Percentage of participants with reported Adverse Events (AE) and Serious Adverse Event (SAE) | The primary analysis will be on the Per-protocol (PP) population. PP population includes all subjects who received the dose of study drug without protocol deviation and had all the assessment per protocol. | Posted | Number | Percentage of participants | 2 weeks |
|
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| 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. | The primary analysis will be on the Per-protocol (PP) population. PP population includes all subjects who received the dose of study drug without protocol deviation and had all the assessment per protocol. | Posted | Mean | Standard Deviation | Scores on JOA | Baseline and 2 weeks |
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| 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. | The primary analysis will be on the Per-protocol (PP) population. PP population includes all subjects who received the dose of study drug without protocol deviation and had all the assessment per protocol. | Posted | Mean | Standard Deviation | Scores on VAS | Baseline and 2 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lumbar Disc Degenerative Disease | Triple therapy ( Methycobal (MBL) + Myonal (MYO) + non-steroidal anti-inflammatory drugs (NSAIDs)) which prescribed by doctors (Drs) based on disease condition. MBL 0.5 mg : three times daily for two weeks, MYO 50 mg : three times daily for two weeks: NSAID (diclofenac) 75 mg,: twice daily for two weeks | 0 | 478 | 13 | 478 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Haibo Song | Eisai China Inc. | 0086-21-24192864 | songhaibo@eisai.com.cn |
| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Title | Measurements |
|---|---|
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| Estimation by Patients: satisfactory |
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| Estimation by Patients: just so so |
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| Estimation by Patients: dissatisfactory |
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