NCT01192113

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

An Open-label, Randomized, Multi-center Clinical Trial to Evaluate the Safety and Efficacy in Peripheral Neuropathies Patients Treated With Mecobalamin Injection

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,072 (actual)
• Sponsor: Eisai Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Peripheral Neuropathy

Interventions

Type	Name	Description
DRUG	Mecobalamin IV Injection	Mecobalamin injection 0.5 mg/ ml administered as an intravenous (IV) injection 3 times a week for four weeks
DRUG	Mecobalamin IM injection	Mecobalamin injection 0.5 mg/ ml administered as an intramuscular (IM) injection 3 times a week for four weeks
DRUG	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

Timeline

• Start date: 2010-04-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2010-08-31
• Last updated: 2012-11-07

Locations

24 sites across 1 country: China