Status:
COMPLETED
Safety and Efficacy of Mecobalamin Injection in Peripheral Neuropathies Patients (Study JGAZSY091109)
Lead Sponsor:
Eisai Co., Ltd.
Conditions:
Peripheral Neuropathy
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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
- Inclusion criteria:
- 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
- Exclusion criteria:
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
1072 Patients enrolled
Trial Details
Trial ID
NCT01192113
Start Date
April 1 2010
End Date
May 1 2011
Last Update
November 7 2012
Active Locations (24)
Enter a location and click search to find clinical trials sorted by distance.
1
The 1st Hospital of Anhui Medical University
Hefei, Anhui, China
2
The General Hospital of the People's Liberation Army
Beijing, Beijing Municipality, China
3
The institute of rehabilitation medicine
Beijing, Beijing Municipality, China
4
Nanfang Hospital of Nanfang Medical Unversity
Guangzhou, Guangdong, China