EUCTR2014-002289-62-IT
Active, not recruiting
Phase 1
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 sitesJuly 3, 2014
DrugsNicetile®
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- SIGMA-TAU, Industrie Farmaceutiche Riunite S.p.A.
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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