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

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ClinicalTrials.gov Identifier: NCT01192113
Recruitment Status : Completed
First Posted : August 31, 2010
Last Update Posted : November 7, 2012
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( 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

Condition or disease Intervention/treatment Phase
Peripheral Neuropathy Drug: Mecobalamin IV Injection Drug: Mecobalamin IM injection Drug: Mecobalamin IV or IM injection Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1072 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Randomized, Multi-center Clinical Trial to Evaluate the Safety and Efficacy in Peripheral Neuropathies Patients Treated With Mecobalamin Injection
Study Start Date : April 2010
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Mecobalamin

Arm Intervention/treatment
Experimental: Group A: Diabetic Peripheral Neuropathy (IV) Drug: Mecobalamin IV Injection
Mecobalamin injection 0.5 mg/ ml administered as an intravenous (IV) injection 3 times a week for four weeks

Experimental: Group B: Diabetic Peripheral Neuropathy (IM) Drug: Mecobalamin IM injection
Mecobalamin injection 0.5 mg/ ml administered as an intramuscular (IM) injection 3 times a week for four weeks

Experimental: Group C: Idiopathic Peripheral Neuropathy 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 D: Nutritional & Metabolic Peripheral Neuropathy 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 E: Compression Peripheral Neuropathy 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




Primary Outcome Measures :
  1. Value of the Peripheral Neuropathy Total Symptom Score (TSS) Compared to Baseline [ Time Frame: 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.

  2. Rate of the Peripheral Neuropathy Total Symptom Score (TSS) Compared to Baseline [ Time Frame: 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 :
  1. Value of the Peripheral Neuropathy Total Symptom Score (TSS) Compared to Baseline [ Time Frame: 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.

  2. Rate of the Peripheral Neuropathy Total Symptom Score (TSS) Compared to Baseline [ Time Frame: 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%.

  3. Value of the Neural Injury Score of the Lower Limbs (NIS-LL) Compared to Baseline [ Time Frame: 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.

  4. Rate of the Neural Injury Score of the Lower Limbs (NIS-LL) Compared to Baseline [ Time Frame: 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%.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01192113


Locations
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Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
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Principal Investigator: Jvming Lu Chinese PLA General Hospital

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Responsible Party: Eisai Co., Ltd.
ClinicalTrials.gov Identifier: NCT01192113    
Other Study ID Numbers: JGAZSY091109
First Posted: August 31, 2010    Key Record Dates
Last Update Posted: November 7, 2012
Last Verified: November 2012
Keywords provided by Eisai Inc. ( Eisai Co., Ltd. ):
Mecobalamin
peripheral neuropathy
diabetic neuropathy
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Vitamin B 12
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs