Who is sponsoring NCT01192113?

NCT01192113 is sponsored by Eisai Co., Ltd..

What condition does NCT01192113 study?

NCT01192113 studies Peripheral Neuropathy.

What drugs are being tested in NCT01192113?

Interventions: Mecobalamin IV Injection, Mecobalamin IM injection, Mecobalamin IV or IM injection.

What is the status of NCT01192113?

NCT01192113 is currently COMPLETED.

Last reviewed 2012-11-05 · How we verify

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

NCT01192113 Phase 4 COMPLETED

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

Details

Lead sponsor	Eisai Co., Ltd.
Phase	Phase 4
Status	COMPLETED
Enrolment	1072
Start date	2010-04
Completion	2011-05

Conditions

Peripheral Neuropathy

Interventions

Mecobalamin IV Injection
Mecobalamin IM injection
Mecobalamin IV or IM injection

Primary outcomes

Value of the Peripheral Neuropathy Total Symptom Score (TSS) Compared to Baseline — Baseline & End of Week 4
The TSS of peripheral neuropathy is used to score the intensity \& frequency of four symptoms in participants' feet/legs including: pain, burning sensation, numbness, and hypoesthesia. Frequency is ranked as asymptomatic, occasionally (2-3 times/ week), often (1-2 times/ day), \& continuous (nearly all day). Intensity is evaluated by visual analogue scale (VAS) score: 0 (zero intensity)- 10 (max. intensity). Participants described intensity by marking the number corresponding to severity of symptom they felt in a 10 cm long straight line and investigators distinguished whether it was mild (score: 1-3), moderate (score: 4-6), or severe (score: 7-10). The total score of four symptoms was considered the TSS. Total scores ranged from 0-14.64 points, where 0 was lowest symptom score and 14.64 was most severe level of symptoms. Baseline (before treatment) scores were compared to scores after 4 weeks of treatment.
Rate of the Peripheral Neuropathy Total Symptom Score (TSS) Compared to Baseline — Baseline and End of Week 4
TSS of peripheral neuropathy is used to score the intensity \& frequency of 4 symptoms in participants' feet/legs including: pain, burning sensation, numbness, hypoesthesia. Frequency is ranked as asymptomatic, occasionally (2-3 times/ week), often (1-2 times/ day), \& continuous (nearly all day). Intensity is evaluated by visual analogue scale (VAS) score: 0 (zero intensity)- 10 (max. intensity). Participants described intensity by marking the number corresponding to severity of symptom they felt in a 10 cm long straight line and investigators distinguished whether it was mild (score: 1-3), moderate (score: 4-6), or severe (score: 7-10). The total score of four symptoms was considered the TSS. Total scores ranged from 0-14.64 points, where 0 was lowest symptom score and 14.64 was most severe level of symptoms. Baseline scores were compared to TSS decreasing rate after 4 weeks of treatment. Rate of TSS change = (TSS difference value/TSS before treatment)×100%.

Countries

China