NENOIN Study

Tahapan Penelitian : Awal
Sponsor:
Mitra Pelaksana:
Prodia Diacro Laboratories, PT (CRO)
No Registry
INA-KPA0DYA
Tanggal Input Registry : 19-07-2016

18-12-2015
Outcome Name: Improvement in clinical symptoms of peripheral neuropathy Metric/method of measurement: Total Symptom Score (TSS) Time-point: 3 months (from baseline up to 3 months of treatment)
Outcome Name: Improvement of Quality of Life (QoL) Metric/method of measurement: Short Form – 8 Health Survey (SF-8) Time-point: 3 months (from baseline up to 3 months of treatment) Outcome Name: Improvement of each symptom of neuropathy (e.g. pain, burning, paresthesia, numbness, etc.) Metric/method of measurement: VAS Score (Visual Analogue Score) Time-point: 3 months (from baseline up to 3 months of treatment) Outcome Name: safety of Neurobion® Forte tablet during the course of the study duration Metric/method of measurement: Report and assessment from investigator Time-point: 3 months (from baseline up to 3 months of treatment)
 
NENOIN Study
Management of peripheral neuropathy symptoms with Neurobion® Forte: A 12 week Prospective Non-interventional (Observational) study in Indonesia
Observasional
NA NENOIN STUDY is designed to be a Phase IV/observational study and non-interventional. This observational study will not interfere with treatment prescription by Investigators. Accordingly, the Investigator will decide in advance the best therapeutic strategy for each subject according to current practice, regardless of the potential participation of the subject in the study. Subsequently, if the prescribed treatment is to be in line with the study protocol inclusion criteria, the Investigator will consider the possibility of including the subject in the study if subject signs informed consent form.
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Inclusion Criteria:

1. Subjects aged ≥18 years (completed) and ≤ 65 years. 2. Subjects willing to provide signed informed consent. 3. Subjects with peripheral neuropathy diagnosed by using either Michigan Neuropathy Screening Instrument (MNSI score of ≥7 in patient administered questionnaire and healthcare professional score of ≥2.5) or Toronto Clinical Neuropathy Score (TCNS) of ≥6. 4. Peripheral neuropathy of various etiology which includes diabetes mellitus/nutritional (e.g. alcoholic neuropathy/dietary deficiency etc.,)/carpel tunnel syndrome/idiopathic/ others.

Exclusion Criteria:

1. Subjects with known clinically significant cardiovascular, pulmonary, gastrointestinal, hematological, hepatic, renal or endocrine diseases (except diabetes mellitus). 2. Subjects who are on any treatment like methotrexate which interferes with neuropathy or any other cytostatic drug treatment to be excluded as per Investigator's discretion. 3. Subjects with known hypersensitivity to any component of Neurobion® Forte tablet. 4. Subjects with history/signs/symptoms suggestive of genetic neuropathy. 5. Subjects taking Vitamin B complex supplements (Vitamin B1 = 100 - 300 mg, B6= 50 - 600 mg and B12= 200 - 5000 mcg; oral or parenteral) more than 1 week consecutively in the last 3 months before consent. 6. Participation in other clinical trials in last one month. 7. Subjects with pregnancy, planning to become pregnant or breast feeding. 8. Subjects who underwent any gastrointestinal surgery in the last 6 months before consent or plan for surgery during the study. 9. Any clinically significant or unstable medical or psychiatric condition that in the opinion of the Investigator would affect the subject’s ability to participate in the study. 10. Subjects with severe neuropathy (Severe: ≥12 with TCNS / ≥7 with VAS for pain) who are prescribed, or who are on therapy with NSAIDs, gabapentin, pregabalin, or any other anti-inflammatory drugs.
 
No. LB.04.01/AOS/EC/483/XII/2015 from Hasan Sadikin Hospital date 3Dec2015; Approval dated 04Feb2016 from Kariadi Hospital; No. 590/Panke.KKE/XI/2015 from Soetomo Hospital date 3Dec2015; No. 232/Kepkrsmh/fkunsri/2015 from Sriwijaya University/M Hoesin Hospital date 05Oct2015; Approval dated 22Sep2015 from Lambung Mangkurat University; No. 642/KOMET/FK USU/2015 from North Sumatera University/Adam Malik Hospital date 8Dec2015; No. 147/H4.8.4.5.31/PP36-KOMETIK/2016 from Hasanuddin University/Wahidin Sudirohusodo Hospital date 29Jan2016
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No. PN.01.313.3.12.15.6802, date: 31 December 2015
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Erizal Sugiono; email: erizal.sugiono@prodia.co.id