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The purpose is to evaluate the safety and efficacy of MESNA in the short-term treatment of persistent pain following surgery of the back.

Conditions
Failed Back Syndrome
MedDRA version: 14.0Level: SOCClassification code 10028395Term: Musculoskeletal and connective tissue disordersSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Registration Number
EUCTR2011-004258-24-IT
Lead Sponsor
IVERSITA' CAMPUS BIOMEDICO
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
All
Target Recruitment
30
Inclusion Criteria

presence of FBSS
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

the presence of infectious processes in place, or impairment of the coagulation cascade to the risk of local complications, and patients are pregnant (and therefore the patients of childbearing age will be made to sign an informed consent to undergo the procedure in which attests not pregnant, as is commonly done for X-rays).

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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