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Clinical Trials/EUCTR2014-002289-62-IT
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

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.

Registry
who.int
Start Date
July 3, 2014
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

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

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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