Skip to main content
OpenTrials
Completed

NCT Number: NCT01299077

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lumbar Disc Degenerative Disease Bone Diseases Intervertebral Disc Degeneration Musculoskeletal Diseases Spinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dongfang Hospital, Shanghai, Shanghai Municipality, China

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Onset Time of Symptom Relief.

    Time frame: 2 weeks

    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. Safety Data During Triple Therapy.

    Time frame: 2 weeks

    Percentage of participants with reported Adverse Events (AE) and Serious Adverse Event (SAE)

  3. Japanese Orthopedic Association (JOA) Score

    Time frame: Baseline and 2 weeks

    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.

  4. Visual Analogue Scale (VAS) Score

    Time frame: Baseline and 2 weeks

    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.

Sponsors and collaborators

Lead sponsor

Eisai China Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Feb 18, 2011
Registry last updated
Dec 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.