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

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eisai Co., Ltd.
• Treatments: Vitamin B 12

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