NCT01299077|CompletedResults

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

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

Eisai China Inc.ClinicalTrials.gov

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1 other identifier

EISAI-MBL-2010-1

Study Type

observational

Target

478

Locations

1 country

Sites

Timeline

RegisteredFeb 2011

StartedJun 2010

CompletionNov 2010

Brief Summary

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

478

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Jun 2010

Shorter than P25 for all trials

Geographic Reach

1 country

10 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5 months study duration

Study Start

First participant enrolled

June 1, 2010

Completed

3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed

4 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2011

Completed

2 days until next milestone

First Posted

Study publicly available on registry

February 18, 2011

Completed

9 months until next milestone

Results Posted

Study results publicly available

November 28, 2011

Completed

Last Updated

December 28, 2011

Status Verified

May 1, 2011

Enrollment Period

3 months

First QC Date

February 16, 2011

Results QC Date

August 16, 2011

Last Update Submit

December 21, 2011

Conditions

Lumbar Disc Degenerative Disease

Keywords

Lumbar disc degenerative diseaseMethycobal

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (4)

Onset Time of Symptom Relief.
2 weeks
Safety Data During Triple Therapy.
2 weeks
Japanese Orthopedic Association (JOA) Score
Baseline and 2 weeks
Visual Analogue Scale (VAS) Score
Baseline and 2 weeks

Study Arms (1)

Lumbar disc degenerative disease

Triple therapy (MBL+ MYO+ NSAIDs) which prescribed by doctors (Drs) based on disease condition

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

outpatients visited to the clinics with lumbar disc degenerative disease

You may qualify if:

lumbar degenerative disc disease (DDD)
patients who have been prescribed over 2 weeks of triple therapy

Contact the study team to confirm eligibility.