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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai China Inc. )
ClinicalTrials.gov Identifier:
NCT01299077
First received: February 16, 2011
Last updated: December 21, 2011
Last verified: May 2011
  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

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
Study Population

outpatients visited to the clinics with lumbar disc degenerative disease

Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01299077

Locations
China, Shanghai
Dongfang Hospital
Shanghai, Shanghai, China
Huashan Hospital
Shanghai, Shanghai, China
Ruijin Hospital
Shanghai, Shanghai, China
Xinhua Hospital
Shanghai, Shanghai, China
Zhongshan Hospital
Shanghai, Shanghai, China
China, Zhejiang
The 1st Hospital of Zhejiang University
Hanzhou, Zhejiang, China
The 2nd Hospital of Zhejiang University
Hanzhou, Zhejiang, China
Traditional Chinese Medicine Hospital of Zhejiang
Hanzhou, Zhejiang, China
Shao Yifu Hospital of Zhejiang University
Hanzhou, Zhejiang, China
The 1st People Hospital of Hanzhou
Hanzhou, Zhejiang, China
Sponsors and Collaborators
Eisai China Inc.
Investigators
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 Disc Degeneration
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Anti-Inflammatory Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014