Lumbar Disc Degenerative DiseaseNCT01299077
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
An observational study of Lumbar Disc Degenerative Disease, run by Eisai China Inc. at 10 sites in China.
Trial summary
The purpose of this study is to observe the overall satisfaction of patients with degenerative disc disease after receiving triple therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Disc Degenerative Disease
- How many people
- 478 participants
- Where
- 10 sitesChina
- Study dates
- Jun 2010to Nov 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: outpatients visited to the clinics with lumbar disc degenerative disease
Who may be able to join
- lumbar degenerative disc disease (DDD)
- patients who have been prescribed over 2 weeks of triple therapy
Who cannot join
- Patients who do not meet inclusion criteria for DDD
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites
Shao Yifu Hospital of Zhejiang University
Hanzhou, Zhejiang
The 1st Hospital of Zhejiang University
Hanzhou, Zhejiang
The 1st People Hospital of Hanzhou
Hanzhou, Zhejiang
The 2nd Hospital of Zhejiang University
Hanzhou, Zhejiang
Traditional Chinese Medicine Hospital of Zhejiang
Hanzhou, Zhejiang
Dongfang Hospital
Shanghai, Shanghai Municipality
Huashan Hospital
Shanghai, Shanghai Municipality
Ruijin Hospital
Shanghai, Shanghai Municipality
Xinhua Hospital
Shanghai, Shanghai Municipality
Zhongshan Hospital
Shanghai, Shanghai Municipality
About this study
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
The purpose of this study is to observe the overall satisfaction of patients with degenerative disc disease after receiving triple therapy.
Read the 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.
- Conditions
- Lumbar Disc Degenerative Disease
- Keywords
- Lumbar disc degenerative disease, Methycobal
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lumbar disc degenerative disease | Triple therapy (MBL+ MYO+ NSAIDs) which prescribed by doctors (Drs) based on disease condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
Secondary outcomes (4)
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.
Measured: 2 weeks
Safety Data During Triple Therapy.
Percentage of participants with reported Adverse Events (AE) and Serious Adverse Event (SAE)
Measured: 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.
Measured: 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.
Measured: Baseline and 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2011 (estimated)
- Study startJun 2010
- Primary completionSep 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lumbar Disc Degenerative DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 478 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai China Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Haibo Song, Study director, Eisai China Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01299077
- Sponsor's protocol ID
- EISAI-MBL-2010-1
- Status last verified
- May 2011
- First submitted
- 16 Feb 2011
- Last updated
- 28 Dec 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01299077
- Acronym / sponsor ID
- EISAI-MBL-2010-1
- Conditions
- Lumbar Disc Degenerative Disease
- Keywords
- Lumbar disc degenerative disease, Methycobal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 478 participants (actual)
- Lead sponsor
- Eisai China Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 18 Feb 2011 (estimated)
- Results
- Posted 28 Nov 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lumbar disc degenerative disease | – | –Triple therapy (MBL+ MYO+ NSAIDs) which prescribed by doctors (Drs) based on disease condition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- outpatients visited to the clinics with lumbar disc degenerative disease
Key inclusion criteria (2 listed)
- lumbar degenerative disc disease (DDD)
- patients who have been prescribed over 2 weeks of triple therapy
Key exclusion criteria (1 listed)
- Patients who do not meet inclusion criteria for DDD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall Satisfaction Degree After 2 Weeks Treatment of Triple Therapy (MBL+MYO+NSAID).
Time frame: 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.
4 secondary outcomes
Onset Time of Symptom Relief.
Time frame: 2 weeks
Safety Data During Triple Therapy.
Time frame: 2 weeks
Japanese Orthopedic Association (JOA) Score
Time frame: Baseline and 2 weeks
Visual Analogue Scale (VAS) Score
Time frame: Baseline and 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haibo Song study director
Eisai China Inc.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Disc Degenerative Disease, run by Eisai China Inc. at 10 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Nov 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Satisfaction Degree After 2 Weeks Treatment of Triple Therapy (MBL+MYO+NSAID). (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2011.