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Safety and Efficacy of Mecobalamin Injection in Peripheral Neuropathies Patients (Study JGAZSY091109)

Primary Purpose

Peripheral Neuropathy

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Mecobalamin IV Injection
Mecobalamin IM injection
Mecobalamin IV or IM injection
Sponsored by
Eisai Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Neuropathy focused on measuring Mecobalamin, peripheral neuropathy, diabetic neuropathy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  1. Clinical diagnosis of diabetes induced peripheral neuropathy, other peripheral neuropathies (Idiopathic, nutritional and metabolic nature of entrapment neuropathy).
  2. Significant spontaneous pain and / or numbness and other symptoms of neuropathy. TSS (Total Symptom Score) >=7.5.
  3. Participation in clinical trials voluntarily and signed informed consent form

Exclusion criteria:

  1. Pregnancy, preparation for pregnancy or breast-feeding women
  2. Peripheral neuropathy caused by drugs, poisoning, cancer or genetic
  3. Alanine aminotransferase (ALT), aspartate aminotransferase (AST): 2.0 times more than the upper limit of normal; Creatinine (Cr) 1.5 times above the upper limit of normal.
  4. Serious organ disease or other serious primary disease merger, the mentally ill, poorly controlled hypertension (blood pressure more than 150/100 mmHg after using antihypertensive drugs)
  5. Diagnosis of patients with diabetic peripheral neuropathy, but has diabetes ketosis, ketoacidosis and severe infection within the past two weeks
  6. Bleeding or bleeding tendency in 2 months
  7. Have allergy
  8. Noncompliance or cannot meet those
  9. Participation in other clinical trials in the last 3 months
  10. Participant unsuitable to participate in this test as investigator considering

Sites / Locations

  • The 1st Hospital of Anhui Medical University
  • The General Hospital of the People's Liberation Army
  • The institute of rehabilitation medicine
  • Nanfang Hospital of Nanfang Medical Unversity
  • The 1st People Hospital of Guangzhou
  • the 1st Hospital affliated to Guangxi Medical University
  • The 3rd Hospital of Hebei Medical University
  • the people Hospital
  • Tongji Hospital
  • Xiehe Hospital
  • the 1st Hospital of Nanjing
  • Zhong Xi Yi Jie He Hospital of Jiangsu
  • the 2nd Hospital of Suzhou University
  • Subei People Hospital
  • The 1st People Hospital of Yangzhou
  • the Affiliated Hospital of Jiangsu University
  • Changhai Hospital
  • Ruijing Hospital
  • the 10th People Hospital of Shanghai
  • the 10th People Hospital
  • The 1st Center Hospital of Tianjin
  • The institute of rehabilitation medicine
  • Rui Jin Hospital
  • Shenzhen Hospital of Beijing University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Group A: Diabetic Peripheral Neuropathy (IV)

Group B: Diabetic Peripheral Neuropathy (IM)

Group C: Idiopathic Peripheral Neuropathy

Group D: Nutritional & Metabolic Peripheral Neuropathy

Group E: Compression Peripheral Neuropathy

Arm Description

Outcomes

Primary Outcome Measures

Value of the Peripheral Neuropathy Total Symptom Score (TSS) Compared to Baseline
The TSS of peripheral neuropathy is used to score the intensity & frequency of four symptoms in participants' feet/legs including: pain, burning sensation, numbness, and hypoesthesia. Frequency is ranked as asymptomatic, occasionally (2-3 times/ week), often (1-2 times/ day), & continuous (nearly all day). Intensity is evaluated by visual analogue scale (VAS) score: 0 (zero intensity)- 10 (max. intensity). Participants described intensity by marking the number corresponding to severity of symptom they felt in a 10 cm long straight line and investigators distinguished whether it was mild (score: 1-3), moderate (score: 4-6), or severe (score: 7-10). The total score of four symptoms was considered the TSS. Total scores ranged from 0-14.64 points, where 0 was lowest symptom score and 14.64 was most severe level of symptoms. Baseline (before treatment) scores were compared to scores after 4 weeks of treatment.
Rate of the Peripheral Neuropathy Total Symptom Score (TSS) Compared to Baseline
TSS of peripheral neuropathy is used to score the intensity & frequency of 4 symptoms in participants' feet/legs including: pain, burning sensation, numbness, hypoesthesia. Frequency is ranked as asymptomatic, occasionally (2-3 times/ week), often (1-2 times/ day), & continuous (nearly all day). Intensity is evaluated by visual analogue scale (VAS) score: 0 (zero intensity)- 10 (max. intensity). Participants described intensity by marking the number corresponding to severity of symptom they felt in a 10 cm long straight line and investigators distinguished whether it was mild (score: 1-3), moderate (score: 4-6), or severe (score: 7-10). The total score of four symptoms was considered the TSS. Total scores ranged from 0-14.64 points, where 0 was lowest symptom score and 14.64 was most severe level of symptoms. Baseline scores were compared to TSS decreasing rate after 4 weeks of treatment. Rate of TSS change = (TSS difference value/TSS before treatment)×100%.

Secondary Outcome Measures

Value of the Peripheral Neuropathy Total Symptom Score (TSS) Compared to Baseline
The TSS of peripheral neuropathy is used to score the intensity & frequency of four symptoms in participants' feet/legs including: pain, burning sensation, numbness, and hypoesthesia. Frequency is ranked as asymptomatic, occasionally (2-3 times/ week), often (1-2 times/ day), & continuous (nearly all day). Intensity is evaluated by visual analogue scale (VAS) score: 0 (zero intensity)- 10 (max. intensity). Participants described intensity by marking the number corresponding to severity of symptom they felt in a 10 cm long straight line and investigators distinguished whether it was mild (score: 1-3), moderate (score: 4-6), or severe (score: 7-10). The total score of four symptoms was considered the TSS. Total scores ranged from 0-14.64 points, where 0 was lowest symptom score and 14.64 was most severe level of symptoms. Baseline (before treatment) scores were compared to scores after 2 weeks of treatment.
Rate of the Peripheral Neuropathy Total Symptom Score (TSS) Compared to Baseline
TSS of peripheral neuropathy is used to score the intensity/ frequency of 4 symptoms in participants' feet/legs including: pain, burning sensation, numbness, and hypoesthesia. Frequency is ranked as asymptomatic, occasionally (2-3 times/ week), often (1-2 times/ day), & continuous (nearly all day). Intensity is evaluated by visual analogue scale (VAS) score: 0 (zero intensity)- 10 (max. intensity). Participants described intensity by marking the number corresponding to severity of symptom they felt in a 10 cm long straight line and investigators distinguished whether it was mild (score: 1-3), moderate (score: 4-6), or severe (score: 7-10). The total score of four symptoms was considered the TSS. Total scores ranged from 0-14.64 points, where 0 was lowest symptom score and 14.64 was most severe level of symptoms. Baseline scores were compared to TSS decreasing rate after 2 weeks of treatment. Rate of TSS change = (TSS difference value/TSS before treatment)×100%.
Value of the Neural Injury Score of the Lower Limbs (NIS-LL) Compared to Baseline
The Neural Injury Score of the Lower Limbs (NIS-LL) was scored based on the following examination items: muscle strength (including hip & knee flexion/ extension & remote foot dorsiflexion/ plantar flexion [scored as normal, 25% weak, 50% weak, 75% weak, and paralysis]), reflex (response at the quadriceps & ankle [normal score=0, decreased score=1, absent score=2], and sensory (tested at the great toe; including touch pressure, pinprick ,vibration, and joint position [normal score=0, decreased score=1, absent score=2]). The Total NIS-LL score ranged from 0-8 points where a higher score means greater neural injury of the lower limbs. Baseline (before treatment) scores were compared to scores after 4 weeks of treatment.
Rate of the Neural Injury Score of the Lower Limbs (NIS-LL) Compared to Baseline
The Neural Injury Score of the Lower Limbs (NIS-LL) was scored based on the following examination items: muscle strength (including hip & knee flexion/ extension & remote foot dorsiflexion/ plantar flexion [scored as normal, 25% weak, 50% weak, 75% weak, and paralysis]), reflex (response at the quadriceps & ankle [normal score=0, decreased score=1, absent score=2], and sensory (tested at the great toe; including touch pressure, pinprick ,vibration, and joint position [normal score=0, decreased score=1, absent score=2]). The Total NIS-LL score ranged from 0-8 points where a higher score means greater neural injury of the lower limbs. Baseline (before treatment) scores were compared to scores after 4 weeks of treatment. Rate of NIS-LL change = (NIS-LL difference value/NIS-LL before treatment)×100%.

Full Information

First Posted
August 26, 2010
Last Updated
November 5, 2012
Sponsor
Eisai Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01192113
Brief Title
Safety and Efficacy of Mecobalamin Injection in Peripheral Neuropathies Patients (Study JGAZSY091109)
Official Title
An Open-label, Randomized, Multi-center Clinical Trial to Evaluate the Safety and Efficacy in Peripheral Neuropathies Patients Treated With Mecobalamin Injection
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Co., Ltd.

4. Oversight

5. Study Description

Brief Summary
This is an open-label, randomized, multi-center clinical trial to evaluate the safety and efficacy in peripheral neuropathies patients treated with Mecobalamin Injection

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Neuropathy
Keywords
Mecobalamin, peripheral neuropathy, diabetic neuropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1072 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A: Diabetic Peripheral Neuropathy (IV)
Arm Type
Experimental
Arm Title
Group B: Diabetic Peripheral Neuropathy (IM)
Arm Type
Experimental
Arm Title
Group C: Idiopathic Peripheral Neuropathy
Arm Type
Experimental
Arm Title
Group D: Nutritional & Metabolic Peripheral Neuropathy
Arm Type
Experimental
Arm Title
Group E: Compression Peripheral Neuropathy
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Mecobalamin IV Injection
Intervention Description
Mecobalamin injection 0.5 mg/ ml administered as an intravenous (IV) injection 3 times a week for four weeks
Intervention Type
Drug
Intervention Name(s)
Mecobalamin IM injection
Intervention Description
Mecobalamin injection 0.5 mg/ ml administered as an intramuscular (IM) injection 3 times a week for four weeks
Intervention Type
Drug
Intervention Name(s)
Mecobalamin IV or IM injection
Intervention Description
Mecobalamin injection 0.5 mg/ ml administered as an IM or IV injection 3 times a week for four weeks
Primary Outcome Measure Information:
Title
Value of the Peripheral Neuropathy Total Symptom Score (TSS) Compared to Baseline
Description
The TSS of peripheral neuropathy is used to score the intensity & frequency of four symptoms in participants' feet/legs including: pain, burning sensation, numbness, and hypoesthesia. Frequency is ranked as asymptomatic, occasionally (2-3 times/ week), often (1-2 times/ day), & continuous (nearly all day). Intensity is evaluated by visual analogue scale (VAS) score: 0 (zero intensity)- 10 (max. intensity). Participants described intensity by marking the number corresponding to severity of symptom they felt in a 10 cm long straight line and investigators distinguished whether it was mild (score: 1-3), moderate (score: 4-6), or severe (score: 7-10). The total score of four symptoms was considered the TSS. Total scores ranged from 0-14.64 points, where 0 was lowest symptom score and 14.64 was most severe level of symptoms. Baseline (before treatment) scores were compared to scores after 4 weeks of treatment.
Time Frame
Baseline & End of Week 4
Title
Rate of the Peripheral Neuropathy Total Symptom Score (TSS) Compared to Baseline
Description
TSS of peripheral neuropathy is used to score the intensity & frequency of 4 symptoms in participants' feet/legs including: pain, burning sensation, numbness, hypoesthesia. Frequency is ranked as asymptomatic, occasionally (2-3 times/ week), often (1-2 times/ day), & continuous (nearly all day). Intensity is evaluated by visual analogue scale (VAS) score: 0 (zero intensity)- 10 (max. intensity). Participants described intensity by marking the number corresponding to severity of symptom they felt in a 10 cm long straight line and investigators distinguished whether it was mild (score: 1-3), moderate (score: 4-6), or severe (score: 7-10). The total score of four symptoms was considered the TSS. Total scores ranged from 0-14.64 points, where 0 was lowest symptom score and 14.64 was most severe level of symptoms. Baseline scores were compared to TSS decreasing rate after 4 weeks of treatment. Rate of TSS change = (TSS difference value/TSS before treatment)×100%.
Time Frame
Baseline and End of Week 4
Secondary Outcome Measure Information:
Title
Value of the Peripheral Neuropathy Total Symptom Score (TSS) Compared to Baseline
Description
The TSS of peripheral neuropathy is used to score the intensity & frequency of four symptoms in participants' feet/legs including: pain, burning sensation, numbness, and hypoesthesia. Frequency is ranked as asymptomatic, occasionally (2-3 times/ week), often (1-2 times/ day), & continuous (nearly all day). Intensity is evaluated by visual analogue scale (VAS) score: 0 (zero intensity)- 10 (max. intensity). Participants described intensity by marking the number corresponding to severity of symptom they felt in a 10 cm long straight line and investigators distinguished whether it was mild (score: 1-3), moderate (score: 4-6), or severe (score: 7-10). The total score of four symptoms was considered the TSS. Total scores ranged from 0-14.64 points, where 0 was lowest symptom score and 14.64 was most severe level of symptoms. Baseline (before treatment) scores were compared to scores after 2 weeks of treatment.
Time Frame
Baseline and End of Week 2
Title
Rate of the Peripheral Neuropathy Total Symptom Score (TSS) Compared to Baseline
Description
TSS of peripheral neuropathy is used to score the intensity/ frequency of 4 symptoms in participants' feet/legs including: pain, burning sensation, numbness, and hypoesthesia. Frequency is ranked as asymptomatic, occasionally (2-3 times/ week), often (1-2 times/ day), & continuous (nearly all day). Intensity is evaluated by visual analogue scale (VAS) score: 0 (zero intensity)- 10 (max. intensity). Participants described intensity by marking the number corresponding to severity of symptom they felt in a 10 cm long straight line and investigators distinguished whether it was mild (score: 1-3), moderate (score: 4-6), or severe (score: 7-10). The total score of four symptoms was considered the TSS. Total scores ranged from 0-14.64 points, where 0 was lowest symptom score and 14.64 was most severe level of symptoms. Baseline scores were compared to TSS decreasing rate after 2 weeks of treatment. Rate of TSS change = (TSS difference value/TSS before treatment)×100%.
Time Frame
Baseline and End of Week 2
Title
Value of the Neural Injury Score of the Lower Limbs (NIS-LL) Compared to Baseline
Description
The Neural Injury Score of the Lower Limbs (NIS-LL) was scored based on the following examination items: muscle strength (including hip & knee flexion/ extension & remote foot dorsiflexion/ plantar flexion [scored as normal, 25% weak, 50% weak, 75% weak, and paralysis]), reflex (response at the quadriceps & ankle [normal score=0, decreased score=1, absent score=2], and sensory (tested at the great toe; including touch pressure, pinprick ,vibration, and joint position [normal score=0, decreased score=1, absent score=2]). The Total NIS-LL score ranged from 0-8 points where a higher score means greater neural injury of the lower limbs. Baseline (before treatment) scores were compared to scores after 4 weeks of treatment.
Time Frame
Baseline and End of Week 4
Title
Rate of the Neural Injury Score of the Lower Limbs (NIS-LL) Compared to Baseline
Description
The Neural Injury Score of the Lower Limbs (NIS-LL) was scored based on the following examination items: muscle strength (including hip & knee flexion/ extension & remote foot dorsiflexion/ plantar flexion [scored as normal, 25% weak, 50% weak, 75% weak, and paralysis]), reflex (response at the quadriceps & ankle [normal score=0, decreased score=1, absent score=2], and sensory (tested at the great toe; including touch pressure, pinprick ,vibration, and joint position [normal score=0, decreased score=1, absent score=2]). The Total NIS-LL score ranged from 0-8 points where a higher score means greater neural injury of the lower limbs. Baseline (before treatment) scores were compared to scores after 4 weeks of treatment. Rate of NIS-LL change = (NIS-LL difference value/NIS-LL before treatment)×100%.
Time Frame
Baseline and End of Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Clinical diagnosis of diabetes induced peripheral neuropathy, other peripheral neuropathies (Idiopathic, nutritional and metabolic nature of entrapment neuropathy). Significant spontaneous pain and / or numbness and other symptoms of neuropathy. TSS (Total Symptom Score) >=7.5. Participation in clinical trials voluntarily and signed informed consent form Exclusion criteria: Pregnancy, preparation for pregnancy or breast-feeding women Peripheral neuropathy caused by drugs, poisoning, cancer or genetic Alanine aminotransferase (ALT), aspartate aminotransferase (AST): 2.0 times more than the upper limit of normal; Creatinine (Cr) 1.5 times above the upper limit of normal. Serious organ disease or other serious primary disease merger, the mentally ill, poorly controlled hypertension (blood pressure more than 150/100 mmHg after using antihypertensive drugs) Diagnosis of patients with diabetic peripheral neuropathy, but has diabetes ketosis, ketoacidosis and severe infection within the past two weeks Bleeding or bleeding tendency in 2 months Have allergy Noncompliance or cannot meet those Participation in other clinical trials in the last 3 months Participant unsuitable to participate in this test as investigator considering
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jvming Lu
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The 1st Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
Country
China
Facility Name
The General Hospital of the People's Liberation Army
City
Beijing
State/Province
Beijing
Country
China
Facility Name
The institute of rehabilitation medicine
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Nanfang Hospital of Nanfang Medical Unversity
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
The 1st People Hospital of Guangzhou
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
the 1st Hospital affliated to Guangxi Medical University
City
Nanning
State/Province
Guangxi
Country
China
Facility Name
The 3rd Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
Country
China
Facility Name
the people Hospital
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Tongji Hospital
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Xiehe Hospital
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
the 1st Hospital of Nanjing
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Zhong Xi Yi Jie He Hospital of Jiangsu
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
the 2nd Hospital of Suzhou University
City
Suzhou
State/Province
Jiangsu
Country
China
Facility Name
Subei People Hospital
City
Yangzhou
State/Province
Jiangsu
Country
China
Facility Name
The 1st People Hospital of Yangzhou
City
Yangzhou
State/Province
Jiangsu
Country
China
Facility Name
the Affiliated Hospital of Jiangsu University
City
Zhenjiang
State/Province
Jiangsu
Country
China
Facility Name
Changhai Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Ruijing Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
the 10th People Hospital of Shanghai
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
the 10th People Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
The 1st Center Hospital of Tianjin
City
Tianjin
State/Province
Tianjin
Country
China
Facility Name
The institute of rehabilitation medicine
City
Beijing
Country
China
Facility Name
Rui Jin Hospital
City
Shanghai
Country
China
Facility Name
Shenzhen Hospital of Beijing University
City
Shenzhen
Country
China

12. IPD Sharing Statement

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Safety and Efficacy of Mecobalamin Injection in Peripheral Neuropathies Patients (Study JGAZSY091109)

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