Electroneurographic and clinical evaluation in patients with mild / moderate Carpal Tunnel Syndrome , following conservative pharmacological treatment with Nicetile®. - Evaluation of patients with carpal tunnel syndrome treated with Nicetile ®.

SIGMA-TAU, Industrie Farmaceutiche Riunite S.p.A.0 个研究点开始时间: 2014年7月3日最近更新: 2017年4月3日

适应症

试验速览

暂无简介。

•1. Patients of both sexes aged = 18 and = 65 years.
•2. Patients with sensory disturbances (BCTQ and Hi-Ob) compatible with carpal tunnel syndrome of not more than 12 months occurrence and CTS electroneurographic diagnosis mild / moderate (according to Padua L. et al., 1998).
•3. Willingness to follow the procedures of the Protocol for at least 120 days.
•4. Obtaining of a written informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 80
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•1. Patient history of surgery for CTS.
•2. Previous infiltrative local therapy with corticosteroids.
•3. Acute trauma to the median nerve.
•4. Previous traumatic fractures of the wrist with joint deformity.
•5. Clinic objectivity compatible with polyneuropathy or cervical radiculopathy.
•6. Rheumatic and autoimmune disorders.
•7. Hypothyroidism or other endocrine disorders, diabetes, BMI = 30; amyloidosis; gout.
•8. Psychiatric disorders.
•9. Chronic or active known infectious diseases, that in the opinion of the investigator may involve the CNS and / or PNS.
•10. Neoplastic disorders in the 5 years prior to enrollment.
•11. Intake of the following drugs in the period prior to screening: 1 week to NSAIDs; 2 weeks for anticonvulsants, steroids, and cannabis derivatives; 2 months for antidepressants); 3 months for L-carnitine or its derivatives and oral hypoglycemic agents.
•12. Drugs or alcohol use.
•13. Known kidney failure (serum creatinine> 2X the upper limit of the reference laboratory of the center).
•14. Known Hepatic impairment (AST and / or ALT> 3X the upper limit of the reference laboratory of the center).
•15. Participation in other clinical trials within the previous 3 months.
•16. Pregnant or breast-feeding women.

发起方

SIGMA-TAU, Industrie Farmaceutiche Riunite S.p.A.