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

Clinical trial to study application of MESNA for infiltration into the epidural ''Failed Back Syndrome'' (FBS)

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-004258-24-IT

Enrollment

Registered

2011-11-29

Start date

2011-09-19

Completion date

Unknown

Last updated

2012-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Failed Back Syndrome MedDRA version: 14.0 Level: SOC Classification code 10028395 Term: Musculoskeletal and connective tissue disorders System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Trade Name: UROMITEXAN*IV 15F 4ML 400MG/4M Pharmaceutical Form: Solution for injection INN or Proposed INN: MESNA CAS Number: 19767-45-4 Concentration unit: mg milligram(s) Concentration type: equal C

Eligibility

Sex/Gender

All

Inclusion criteria

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

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).

Design outcomes

Secondary

Measure	Time frame
Secondary end point(s): na;Timepoint(s) of evaluation of this end point: na	—

Primary

Measure	Time frame
Secondary Objective: na;Primary end point(s): reduced consumption of opioids and analgesics drugs.;Timepoint(s) of evaluation of this end point: Pre-first procedure 48h post-first procedure Pre-second procedure 48h post-second procedure pre-third procedure 48h after the third procedure 1 week after the third procedure 1 month after the third procedure 3 months after the third procedure;Main Objective: The dual direct action: a) stone on the branches of fibrosis, b) radical scavenger on the production of free radicals explicated by the drug when applied locally, we expect will promote root decompression and debridement by a fibrous tissue resulting in significant reduction (and in some cases resolution) of pain and therefore a functional improvement	—

Measure

Time frame

Secondary Objective: na;Primary end point(s): reduced consumption of opioids and analgesics drugs.;Timepoint(s) of evaluation of this end point: Pre-first procedure 48h post-first procedure Pre-second procedure 48h post-second procedure pre-third procedure 48h after the third procedure 1 week after the third procedure 1 month after the third procedure 3 months after the third procedure;Main Objective: The dual direct action: a) stone on the branches of fibrosis, b) radical scavenger on the production of free radicals explicated by the drug when applied locally, we expect will promote root decompression and debridement by a fibrous tissue resulting in significant reduction (and in some cases resolution) of pain and therefore a functional improvement

—

Countries

Italy

Contacts

Public ContactRIANIMAZIONE

UNIVERSITA' CAMPUS BIO-MEDICO DI ROMA

M.CARASSITI@UNICAMPUS.IT06225411181

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026