Safety and Efficacy of Mecobalamin Injection in Peripheral Neuropathies Patients (Study JGAZSY091109)
NCT ID: NCT01192113
Last Updated: 2012-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
1072 participants
INTERVENTIONAL
2010-04-30
2011-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A: Diabetic Peripheral Neuropathy (IV)
Mecobalamin IV Injection
Mecobalamin injection 0.5 mg/ ml administered as an intravenous (IV) injection 3 times a week for four weeks
Group B: Diabetic Peripheral Neuropathy (IM)
Mecobalamin IM injection
Mecobalamin injection 0.5 mg/ ml administered as an intramuscular (IM) injection 3 times a week for four weeks
Group C: Idiopathic Peripheral Neuropathy
Mecobalamin IV or IM injection
Mecobalamin injection 0.5 mg/ ml administered as an IM or IV injection 3 times a week for four weeks
Group D: Nutritional & Metabolic Peripheral Neuropathy
Mecobalamin IV or IM injection
Mecobalamin injection 0.5 mg/ ml administered as an IM or IV injection 3 times a week for four weeks
Group E: Compression Peripheral Neuropathy
Mecobalamin IV or IM injection
Mecobalamin injection 0.5 mg/ ml administered as an IM or IV injection 3 times a week for four weeks
Interventions
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Mecobalamin IV Injection
Mecobalamin injection 0.5 mg/ ml administered as an intravenous (IV) injection 3 times a week for four weeks
Mecobalamin IM injection
Mecobalamin injection 0.5 mg/ ml administered as an intramuscular (IM) injection 3 times a week for four weeks
Mecobalamin IV or IM injection
Mecobalamin injection 0.5 mg/ ml administered as an IM or IV injection 3 times a week for four weeks
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
75 Years
ALL
No
Sponsors
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Eisai Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Jvming Lu
Role: PRINCIPAL_INVESTIGATOR
Chinese PLA General Hospital
Locations
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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
Countries
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Other Identifiers
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JGAZSY091109
Identifier Type: -
Identifier Source: org_study_id