Safety and Efficacy of Mecobalamin Injection in Peripheral Neuropathies Patients (Study JGAZSY091109)
- Conditions
- Peripheral Neuropathy
- Interventions
- Registration Number
- NCT01192113
- Lead Sponsor
- Eisai Co., Ltd.
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1072
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group D: Nutritional & Metabolic Peripheral Neuropathy Mecobalamin IV or IM injection - Group E: Compression Peripheral Neuropathy Mecobalamin IV or IM injection - Group A: Diabetic Peripheral Neuropathy (IV) Mecobalamin IV Injection - Group B: Diabetic Peripheral Neuropathy (IM) Mecobalamin IM injection - Group C: Idiopathic Peripheral Neuropathy Mecobalamin IV or IM injection -
- Primary Outcome Measures
Name Time Method 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%.
- Secondary Outcome Measures
Name Time Method Value of the Peripheral Neuropathy Total Symptom Score (TSS) Compared to Baseline Baseline and End of Week 2 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 2 weeks of treatment.
Rate of the Peripheral Neuropathy Total Symptom Score (TSS) Compared to Baseline Baseline and End of Week 2 TSS of peripheral neuropathy is used to score the intensity/ frequency of 4 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 scores were compared to TSS decreasing rate after 2 weeks of treatment. Rate of TSS change = (TSS difference value/TSS before treatment)×100%.
Value of the Neural Injury Score of the Lower Limbs (NIS-LL) Compared to Baseline Baseline and End of Week 4 The Neural Injury Score of the Lower Limbs (NIS-LL) was scored based on the following examination items: muscle strength (including hip \& knee flexion/ extension \& remote foot dorsiflexion/ plantar flexion \[scored as normal, 25% weak, 50% weak, 75% weak, and paralysis\]), reflex (response at the quadriceps \& ankle \[normal score=0, decreased score=1, absent score=2\], and sensory (tested at the great toe; including touch pressure, pinprick ,vibration, and joint position \[normal score=0, decreased score=1, absent score=2\]). The Total NIS-LL score ranged from 0-8 points where a higher score means greater neural injury of the lower limbs. Baseline (before treatment) scores were compared to scores after 4 weeks of treatment.
Rate of the Neural Injury Score of the Lower Limbs (NIS-LL) Compared to Baseline Baseline and End of Week 4 The Neural Injury Score of the Lower Limbs (NIS-LL) was scored based on the following examination items: muscle strength (including hip \& knee flexion/ extension \& remote foot dorsiflexion/ plantar flexion \[scored as normal, 25% weak, 50% weak, 75% weak, and paralysis\]), reflex (response at the quadriceps \& ankle \[normal score=0, decreased score=1, absent score=2\], and sensory (tested at the great toe; including touch pressure, pinprick ,vibration, and joint position \[normal score=0, decreased score=1, absent score=2\]). The Total NIS-LL score ranged from 0-8 points where a higher score means greater neural injury of the lower limbs. Baseline (before treatment) scores were compared to scores after 4 weeks of treatment. Rate of NIS-LL change = (NIS-LL difference value/NIS-LL before treatment)×100%.
Trial Locations
- Locations (23)
the 2nd Hospital of Suzhou University
🇨🇳Suzhou, Jiangsu, China
Subei People Hospital
🇨🇳Yangzhou, Jiangsu, China
The 1st People Hospital of Yangzhou
🇨🇳Yangzhou, Jiangsu, China
Changhai Hospital
🇨🇳Shanghai, Shanghai, China
Ruijing Hospital
🇨🇳Shanghai, Shanghai, China
the 10th People Hospital of Shanghai
🇨🇳Shanghai, Shanghai, China
The 1st Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
Zhong Xi Yi Jie He Hospital of Jiangsu
🇨🇳Nanjing, Jiangsu, China
Tongji Hospital
🇨🇳Wuhan, Hubei, China
The General Hospital of the People's Liberation Army
🇨🇳Beijing, Beijing, China
The 3rd Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Xiehe Hospital
🇨🇳Wuhan, Hubei, China
The institute of rehabilitation medicine
🇨🇳Beijing, China
Nanfang Hospital of Nanfang Medical Unversity
🇨🇳Guangzhou, Guangdong, China
The 1st People Hospital of Guangzhou
🇨🇳Guangzhou, Guangdong, China
Rui Jin Hospital
🇨🇳Shanghai, China
the 1st Hospital of Nanjing
🇨🇳Nanjing, Jiangsu, China
the people Hospital
🇨🇳Wuhan, Hubei, China
the 1st Hospital affliated to Guangxi Medical University
🇨🇳Nanning, Guangxi, China
the 10th People Hospital
🇨🇳Shanghai, Shanghai, China
the Affiliated Hospital of Jiangsu University
🇨🇳Zhenjiang, Jiangsu, China
The 1st Center Hospital of Tianjin
🇨🇳Tianjin, Tianjin, China
Shenzhen Hospital of Beijing University
🇨🇳Shenzhen, China