Clinical trial NCT01192113: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Peripheral Neuropathy
Keywords: Mecobalamin
peripheral neuropathy
diabetic neuropathy
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2010-08-31
Enrollment: 1072
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Value of the Peripheral Neuropathy Total Symptom Score (TSS) Compared to Baseline
timeFrame: Baseline & End of Week 4
measure: Rate of the Peripheral Neuropathy Total Symptom Score (TSS) Compared to Baseline
timeFrame: Baseline and End of Week 4
Secondary outcomes:
measure: Value of the Peripheral Neuropathy Total Symptom Score (TSS) Compared to Baseline
timeFrame: Baseline and End of Week 2
measure: Rate of the Peripheral Neuropathy Total Symptom Score (TSS) Compared to Baseline
timeFrame: Baseline and End of Week 2
measure: Value of the Neural Injury Score of the Lower Limbs (NIS-LL) Compared to Baseline
timeFrame: Baseline and End of Week 4
measure: Rate of the Neural Injury Score of the Lower Limbs (NIS-LL) Compared to Baseline
timeFrame: Baseline and End of Week 4
Other outcomes:
Locations:
city: Hefei
country: China
facility: The 1st Hospital of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: The General Hospital of the People's Liberation Army
state: Beijing
city: Beijing
country: China
facility: The institute of rehabilitation medicine
state: Beijing
city: Guangzhou
country: China
facility: Nanfang Hospital of Nanfang Medical Unversity
state: Guangdong
city: Guangzhou
country: China
facility: The 1st People Hospital of Guangzhou
state: Guangdong
city: Nanning
country: China
facility: the 1st Hospital affliated to Guangxi Medical University
state: Guangxi
city: Shijiazhuang
country: China
facility: The 3rd Hospital of Hebei Medical University
state: Hebei
city: Wuhan
country: China
facility: the people Hospital
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
city: Wuhan
country: China
facility: Xiehe Hospital
state: Hubei
city: Nanjing
country: China
facility: the 1st Hospital of Nanjing
state: Jiangsu
city: Nanjing
country: China
facility: Zhong Xi Yi Jie He Hospital of Jiangsu
state: Jiangsu
city: Suzhou
country: China
facility: the 2nd Hospital of Suzhou University
state: Jiangsu
city: Yangzhou
country: China
facility: Subei People Hospital
state: Jiangsu
city: Yangzhou
country: China
facility: The 1st People Hospital of Yangzhou
state: Jiangsu
city: Zhenjiang
country: China
facility: the Affiliated Hospital of Jiangsu University
state: Jiangsu
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
city: Shanghai
country: China
facility: Ruijing Hospital
state: Shanghai
city: Shanghai
country: China
facility: the 10th People Hospital of Shanghai
state: Shanghai
city: Shanghai
country: China
facility: the 10th People Hospital
state: Shanghai
city: Tianjin
country: China
facility: The 1st Center Hospital of Tianjin
state: Tianjin
city: Beijing
country: China
facility: The institute of rehabilitation medicine
city: Shanghai
country: China
facility: Rui Jin Hospital
city: Shenzhen
country: China
facility: Shenzhen Hospital of Beijing University
Study officials:
affiliation: Chinese PLA General Hospital
name: Jvming Lu
role: PRINCIPAL_INVESTIGATOR
References: