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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT01192113
First received: August 26, 2010
Last updated: November 5, 2012
Last verified: November 2012

August 26, 2010
November 5, 2012
April 2010
May 2011   (final data collection date for primary outcome measure)
  • Value of the Peripheral Neuropathy Total Symptom Score (TSS) Compared to Baseline [ Time Frame: Baseline & End of Week 4 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and End of Week 4 ] [ Designated as safety issue: No ]
    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%.
The difference and change rate of Total Symptom Score (TSS) before and after the experiment. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01192113 on ClinicalTrials.gov Archive Site
  • Value of the Peripheral Neuropathy Total Symptom Score (TSS) Compared to Baseline [ Time Frame: Baseline and End of Week 2 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and End of Week 2 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and End of Week 4 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and End of Week 4 ] [ Designated as safety issue: No ]
    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%.
The difference of NIS-LL before and after the experiment. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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

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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Peripheral Neuropathy
  • 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
  • Experimental: Group A: Diabetic Peripheral Neuropathy (IV)
    Intervention: Drug: Mecobalamin IV Injection
  • Experimental: Group B: Diabetic Peripheral Neuropathy (IM)
    Intervention: Drug: Mecobalamin IM injection
  • Experimental: Group C: Idiopathic Peripheral Neuropathy
    Intervention: Drug: Mecobalamin IV or IM injection
  • Experimental: Group D: Nutritional & Metabolic Peripheral Neuropathy
    Intervention: Drug: Mecobalamin IV or IM injection
  • Experimental: Group E: Compression Peripheral Neuropathy
    Intervention: Drug: Mecobalamin IV or IM injection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1072
May 2011
May 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01192113
JGAZSY091109
Not Provided
Eisai Inc. ( Eisai Co., Ltd. )
Eisai Co., Ltd.
Not Provided
Principal Investigator: Jvming Lu The General Hospital of the People's Liberation Army
Eisai Inc.
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP