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

Eisai

Status and phase: Completed; Phase 4

Conditions: Peripheral Neuropathy

Treatments: Drug: Mecobalamin IV Injection; Drug: Mecobalamin IM injection; Drug: Mecobalamin IV or IM injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT01192113

JGAZSY091109

Details and patient eligibility

About

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

Enrollment: 1,072 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,072 participants in 5 patient groups

Group A: Diabetic Peripheral Neuropathy (IV)

Experimental group

Treatment:

Drug: Mecobalamin IV Injection

Group B: Diabetic Peripheral Neuropathy (IM)

Experimental group

Treatment:

Drug: Mecobalamin IM injection

Group C: Idiopathic Peripheral Neuropathy

Experimental group

Treatment:

Drug: Mecobalamin IV or IM injection

Group D: Nutritional & Metabolic Peripheral Neuropathy

Experimental group

Treatment:

Drug: Mecobalamin IV or IM injection

Group E: Compression Peripheral Neuropathy

Experimental group

Treatment:

Drug: Mecobalamin IV or IM injection