Safety and Efficacy of Mecobalamin Injection in Peripheral Neuropathies Patients (Study JGAZSY091109)
An Open-label, Randomized, Multi-center Clinical Trial to Evaluate the Safety and Efficacy in Peripheral Neuropathies Patients Treated With Mecobalamin Injection
1 other identifier
interventional
1,072
1 country
24
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2010
Shorter than P25 for phase_4
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 26, 2010
CompletedFirst Posted
Study publicly available on registry
August 31, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedNovember 7, 2012
November 1, 2012
1.1 years
August 26, 2010
November 5, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
Baseline & End of Week 4
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)Ă—100%.
Baseline and End of Week 4
Secondary Outcomes (4)
Value of the Peripheral Neuropathy Total Symptom Score (TSS) Compared to Baseline
Baseline and End of Week 2
Rate of the Peripheral Neuropathy Total Symptom Score (TSS) Compared to Baseline
Baseline and End of Week 2
Value of the Neural Injury Score of the Lower Limbs (NIS-LL) Compared to Baseline
Baseline and End of Week 4
Rate of the Neural Injury Score of the Lower Limbs (NIS-LL) Compared to Baseline
Baseline and End of Week 4
Study Arms (5)
Group A: Diabetic Peripheral Neuropathy (IV)
EXPERIMENTALGroup B: Diabetic Peripheral Neuropathy (IM)
EXPERIMENTALGroup C: Idiopathic Peripheral Neuropathy
EXPERIMENTALGroup D: Nutritional & Metabolic Peripheral Neuropathy
EXPERIMENTALGroup E: Compression Peripheral Neuropathy
EXPERIMENTALInterventions
Mecobalamin injection 0.5 mg/ ml administered as an intravenous (IV) injection 3 times a week for four weeks
Mecobalamin injection 0.5 mg/ ml administered as an intramuscular (IM) injection 3 times a week for four weeks
Mecobalamin injection 0.5 mg/ ml administered as an IM or IV injection 3 times a week for four weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Co., Ltd.lead
Study Sites (24)
The 1st Hospital of Anhui Medical University
Hefei, Anhui, China
The General Hospital of the People's Liberation Army
Beijing, Beijing Municipality, China
The institute of rehabilitation medicine
Beijing, Beijing Municipality, China
Nanfang Hospital of Nanfang Medical Unversity
Guangzhou, Guangdong, China
The 1st People Hospital of Guangzhou
Guangzhou, Guangdong, China
the 1st Hospital affliated to Guangxi Medical University
Nanning, Guangxi, China
The 3rd Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
the people Hospital
Wuhan, Hubei, China
Tongji Hospital
Wuhan, Hubei, China
Xiehe Hospital
Wuhan, Hubei, China
the 1st Hospital of Nanjing
Nanjing, Jiangsu, China
Zhong Xi Yi Jie He Hospital of Jiangsu
Nanjing, Jiangsu, China
the 2nd Hospital of Suzhou University
Suzhou, Jiangsu, China
Subei People Hospital
Yangzhou, Jiangsu, China
The 1st People Hospital of Yangzhou
Yangzhou, Jiangsu, China
the Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
Changhai Hospital
Shanghai, Shanghai Municipality, China
Ruijing Hospital
Shanghai, Shanghai Municipality, China
the 10th People Hospital of Shanghai
Shanghai, Shanghai Municipality, China
the 10th People Hospital
Shanghai, Shanghai Municipality, China
The 1st Center Hospital of Tianjin
Tianjin, Tianjin Municipality, China
The institute of rehabilitation medicine
Beijing, China
Rui Jin Hospital
Shanghai, China
Shenzhen Hospital of Beijing University
Shenzhen, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jvming Lu
Chinese PLA General Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2010
First Posted
August 31, 2010
Study Start
April 1, 2010
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
November 7, 2012
Record last verified: 2012-11