Evaluation of patients with carpal tunnel syndrome treated with Nicetile ®.

Phase 1

• Conditions: Carpal Tunnel Syndrome; MedDRA version: 17.0Level: PTClassification code 10007697Term: Carpal tunnel syndromeSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2014-002289-62-IT
• Lead Sponsor: SIGMA-TAU, Industrie Farmaceutiche Riunite S.p.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-03
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified