Peripheral NeuropathyPhase 4NCT01192113
Safety and Efficacy of Mecobalamin Injection in Peripheral Neuropathies Patients (Study JGAZSY091109)
A Phase 4 study testing Mecobalamin IV Injection, Mecobalamin IM injection and Mecobalamin IV or IM injection in people with Peripheral Neuropathy, run by Eisai Co., Ltd. at 24 sites in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Peripheral Neuropathy
- What is being tested?
- Mecobalamin IV Injection, Mecobalamin IM injection and Mecobalamin IV or IM injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,072 participants
- Where
- 24 sitesChina
- Study dates
- Apr 2010to May 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of diabetes induced peripheral neuropathy, other peripheral neuropathies (Idiopathic, nutritional and metabolic nature of entrapment neuropathy).
- Significant spontaneous pain and / or numbness and other symptoms of neuropathy. TSS (Total Symptom Score) >=7.5.
- Participation in clinical trials voluntarily and signed informed consent form
Who cannot join
- Pregnancy, preparation for pregnancy or breast-feeding women
- Peripheral neuropathy caused by drugs, poisoning, cancer or genetic
- 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.
- 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)
- Diagnosis of patients with diabetic peripheral neuropathy, but has diabetes ketosis, ketoacidosis and severe infection within the past two weeks
- Bleeding or bleeding tendency in 2 months
Show all 10Show fewer
- Have allergy
- Noncompliance or cannot meet those
- Participation in other clinical trials in the last 3 months
- Participant unsuitable to participate in this test as investigator considering
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
China24 sites
The General Hospital of the People's Liberation Army
Beijing, Beijing Municipality
The institute of rehabilitation medicine
Beijing, Beijing Municipality
The institute of rehabilitation medicine
Beijing
Nanfang Hospital of Nanfang Medical Unversity
Guangzhou, Guangdong
The 1st People Hospital of Guangzhou
Guangzhou, Guangdong
The 1st Hospital of Anhui Medical University
Hefei, Anhui
the 1st Hospital of Nanjing
Nanjing, Jiangsu
Zhong Xi Yi Jie He Hospital of Jiangsu
Nanjing, Jiangsu
the 1st Hospital affliated to Guangxi Medical University
Nanning, Guangxi
Changhai Hospital
Shanghai, Shanghai Municipality
Ruijing Hospital
Shanghai, Shanghai Municipality
the 10th People Hospital of Shanghai
Shanghai, Shanghai Municipality
the 10th People Hospital
Shanghai, Shanghai Municipality
Rui Jin Hospital
Shanghai
Shenzhen Hospital of Beijing University
Shenzhen
The 3rd Hospital of Hebei Medical University
Shijiazhuang, Hebei
the 2nd Hospital of Suzhou University
Suzhou, Jiangsu
The 1st Center Hospital of Tianjin
Tianjin, Tianjin Municipality
the people Hospital
Wuhan, Hubei
Tongji Hospital
Wuhan, Hubei
Xiehe Hospital
Wuhan, Hubei
Subei People Hospital
Yangzhou, Jiangsu
The 1st People Hospital of Yangzhou
Yangzhou, Jiangsu
the Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu
About this study
Official title: 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
- Conditions
- Peripheral Neuropathy
- Being tested
- Mecobalamin IV Injection, Mecobalamin IM injection, Mecobalamin IV or IM injection
- Keywords
- Mecobalamin, peripheral neuropathy, diabetic neuropathy
- Medical subject headings
- Peripheral Nervous System Diseases, Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mecobalamin IV InjectionDrug
Mecobalamin injection 0.5 mg/ ml administered as an intravenous (IV) injection 3 times a week for four weeks
Mecobalamin IM injectionDrug
Mecobalamin injection 0.5 mg/ ml administered as an intramuscular (IM) injection 3 times a week for four weeks
Mecobalamin IV or IM injectionDrug
Mecobalamin injection 0.5 mg/ ml administered as an IM or IV injection 3 times a week for four weeks
| Study group | Role | What they receive |
|---|---|---|
| Group A: Diabetic Peripheral Neuropathy (IV) | Experimental | Not described Receives: Drug: Mecobalamin IV Injection |
| Group B: Diabetic Peripheral Neuropathy (IM) | Experimental | Not described Receives: Drug: Mecobalamin IM injection |
| Group C: Idiopathic Peripheral Neuropathy | Experimental | Not described Receives: Drug: Mecobalamin IV or IM injection |
| Group D: Nutritional & Metabolic Peripheral Neuropathy | Experimental | Not described Receives: Drug: Mecobalamin IV or IM injection |
| Group E: Compression Peripheral Neuropathy | Experimental | Not described Receives: Drug: Mecobalamin IV or IM injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Value of the Peripheral Neuropathy Total Symptom Score (TSS) Compared to Baseline
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.
Measured: Baseline & End of Week 4
Rate of the Peripheral Neuropathy Total Symptom Score (TSS) Compared to Baseline
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%.
Measured: Baseline and End of Week 4
Secondary outcomes (4)
Value of the Peripheral Neuropathy Total Symptom Score (TSS) Compared to Baseline
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.
Measured: Baseline and End of Week 2
Rate of the Peripheral Neuropathy Total Symptom Score (TSS) Compared to Baseline
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%.
Measured: Baseline and End of Week 2
Value of the Neural Injury Score of the Lower Limbs (NIS-LL) Compared to Baseline
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.
Measured: Baseline and End of Week 4
Rate of the Neural Injury Score of the Lower Limbs (NIS-LL) Compared to Baseline
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%.
Measured: Baseline and End of Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2010 (estimated)
- Study startApr 2010
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,072 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jvming Lu, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01192113
- Sponsor's protocol ID
- JGAZSY091109
- Status last verified
- Nov 2012
- First submitted
- 26 Aug 2010
- Last updated
- 7 Nov 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Multi-center Clinical Trial to Evaluate the Safety and Efficacy in Peripheral Neuropathies Patients Treated With Mecobalamin Injection
- ClinicalTrials.gov ID
- NCT01192113
- Acronym / sponsor ID
- JGAZSY091109
- Conditions
- Peripheral Neuropathy
- Keywords
- Mecobalamin, peripheral neuropathy, diabetic neuropathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,072 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 31 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, randomized, multi-center clinical trial to evaluate the safety and efficacy in peripheral neuropathies patients treated with Mecobalamin Injection
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group A: Diabetic Peripheral Neuropathy (IV) | Experimental | Drug: Mecobalamin IV Injection |
| Group B: Diabetic Peripheral Neuropathy (IM) | Experimental | Drug: Mecobalamin IM injection |
| Group C: Idiopathic Peripheral Neuropathy | Experimental | Drug: Mecobalamin IV or IM injection |
| Group D: Nutritional & Metabolic Peripheral Neuropathy | Experimental | Drug: Mecobalamin IV or IM injection |
| Group E: Compression Peripheral Neuropathy | Experimental | Drug: Mecobalamin IV or IM injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of diabetes induced peripheral neuropathy, other peripheral neuropathies (Idiopathic, nutritional and metabolic nature of entrapment neuropathy).
- Significant spontaneous pain and / or numbness and other symptoms of neuropathy. TSS (Total Symptom Score) >=7.5.
- Participation in clinical trials voluntarily and signed informed consent form
Key exclusion criteria (10 listed)
- Pregnancy, preparation for pregnancy or breast-feeding women
- Peripheral neuropathy caused by drugs, poisoning, cancer or genetic
- 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.
- 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)
- Diagnosis of patients with diabetic peripheral neuropathy, but has diabetes ketosis, ketoacidosis and severe infection within the past two weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mecobalamin IV InjectionMecobalamin injection 0.5 mg/ ml administered as an intravenous (IV) injection 3 times a week for four weeks | Drug | Group A: Diabetic Peripheral Neuropathy (IV) |
| Mecobalamin IM injectionMecobalamin injection 0.5 mg/ ml administered as an intramuscular (IM) injection 3 times a week for four weeks | Drug | Group B: Diabetic Peripheral Neuropathy (IM) |
| Mecobalamin IV or IM injectionMecobalamin injection 0.5 mg/ ml administered as an IM or IV injection 3 times a week for four weeks | Drug | Group C: Idiopathic Peripheral Neuropathy, Group D: Nutritional & Metabolic Peripheral Neuropathy, Group E: Compression Peripheral Neuropathy |
Primary outcome
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.
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%.
4 secondary outcomes
Value of the Peripheral Neuropathy Total Symptom Score (TSS) Compared to Baseline
Time frame: Baseline and End of Week 2
Rate of the Peripheral Neuropathy Total Symptom Score (TSS) Compared to Baseline
Time frame: Baseline and End of Week 2
Value of the Neural Injury Score of the Lower Limbs (NIS-LL) Compared to Baseline
Time frame: Baseline and End of Week 4
Rate of the Neural Injury Score of the Lower Limbs (NIS-LL) Compared to Baseline
Time frame: Baseline and End of Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jvming Lu principal investigator
Chinese PLA General Hospital
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mecobalamin IV Injection, Mecobalamin IM injection and Mecobalamin IV or IM injection in people with Peripheral Neuropathy, run by Eisai Co., Ltd. at 24 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Value of the Peripheral Neuropathy Total Symptom Score (TSS) Compared to Baseline (time frame: Baseline & End of Week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2012.