Trial Outcomes & Findings for 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 (NCT NCT01299077)

NCT ID: NCT01299077

Last Updated: 2011-12-28

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

478 participants

Primary outcome timeframe

2 weeks

Results posted on

2011-12-28

Participant Flow

This study was recruited at 10 centers in China during the period of 09-Jun-2010 to 28-Sept-2010 .

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	478
Overall Study COMPLETED	478
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lumbar Disc Degenerative Disease n=478 Participants 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
Age Continuous	50.34 years STANDARD_DEVIATION 12.63 • n=5 Participants
Sex: Female, Male Female	252 Participants n=5 Participants
Sex: Female, Male Male	226 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	478 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Lumbar Disc Degenerative Disease n=478 Participants 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
Overall Satisfaction Degree After 2 Weeks Treatment of Triple Therapy (MBL+MYO+NSAID). Estimation by Physicians: satisfactory	91.21 percentage of participants
Overall Satisfaction Degree After 2 Weeks Treatment of Triple Therapy (MBL+MYO+NSAID). Estimation by Physicians: just so so	7.74 percentage of participants
Overall Satisfaction Degree After 2 Weeks Treatment of Triple Therapy (MBL+MYO+NSAID). Estimation by Physicians: dissatisfactory	1.05 percentage of participants
Overall Satisfaction Degree After 2 Weeks Treatment of Triple Therapy (MBL+MYO+NSAID). Estimation by Patients: satisfactory	86.4 percentage of participants
Overall Satisfaction Degree After 2 Weeks Treatment of Triple Therapy (MBL+MYO+NSAID). Estimation by Patients: just so so	12.76 percentage of participants
Overall Satisfaction Degree After 2 Weeks Treatment of Triple Therapy (MBL+MYO+NSAID). Estimation by Patients: dissatisfactory	0.84 percentage of participants

SECONDARY outcome

Timeframe: 2 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Lumbar Disc Degenerative Disease n=478 Participants 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
Onset Time of Symptom Relief.	4.68 Average Days of Onset Time Standard Deviation 2.61

SECONDARY outcome

Timeframe: 2 weeks

Population: 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.

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

Outcome measures

Outcome measures
Measure	Lumbar Disc Degenerative Disease n=478 Participants 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
Safety Data During Triple Therapy. SAE	0 Percentage of participants
Safety Data During Triple Therapy. AE	2.7 Percentage of participants

SECONDARY outcome

Timeframe: Baseline and 2 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Lumbar Disc Degenerative Disease n=478 Participants 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
Japanese Orthopedic Association (JOA) Score Baseline	15.72 Scores on JOA Standard Deviation 3.51
Japanese Orthopedic Association (JOA) Score 2 weeks	21.28 Scores on JOA Standard Deviation 3.41

SECONDARY outcome

Timeframe: Baseline and 2 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Lumbar Disc Degenerative Disease n=478 Participants 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
Visual Analogue Scale (VAS) Score Baseline	6.23 Scores on VAS Standard Deviation 1.38
Visual Analogue Scale (VAS) Score 2 weeks	2.61 Scores on VAS Standard Deviation 1.70

Adverse Events

Lumbar Disc Degenerative Disease

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Lumbar Disc Degenerative Disease n=478 participants at risk 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
Gastrointestinal disorders Abdominal discomfort	2.7% 13/478

Additional Information

Haibo Song

Eisai China Inc.

Phone: 0086-21-24192864

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place