Last reviewed · How we verify

NCT02151045: EPI-AMELIE

Comparison of a Cortivazol (ALTIM®) Infiltration of Posterior Epidural Space at L3-L4 Stage Versus an Epidural Infiltration of Cortivazol (ALTIM®) on Contact With Disco Radicular Conflict in Discal Sciatica - Controlled Randomized Trial With Double Blind Evaluation

Status unknown Phase 3 Last updated 31 August 2015
What this trial tests

Phase 3 trial testing Non target epidural infiltration done at L3-L4 stage in Discal Sciatica in 112 participants. Status unknown.

Timeline
1 March 2012
Primary endpoint
1 March 2017
1 March 2017

Quick facts

Lead sponsorUniversity Hospital, Montpellier
PhasePhase 3
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment112
Start date1 March 2012
Primary completion1 March 2017
Estimated completion1 March 2017
Sites2 locations across France

Drugs / interventions tested

Conditions studied

Sponsor

University Hospital, Montpellier

Who can join

Adults 18 to 65, any sex, with Discal Sciatica. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

In discal sciatica, after failure of medical treatment, the investigators propose frequently a spinal infiltration of corticoids the most closer of disco-radicular conflict. Recently, some cases of paraplegia during lumbar foraminal infiltrations have induce a reduction of indications of this type of infiltration. An alternative would be to propose a lateral epidural infiltration on contact with conflict.The objective of this study is to compare, in 112 patients with a less than 6 months discal sciatica, the efficacy on pain of a non target posterior epidural space infiltration of corticoids done at L3-L4 stage on scan control versus an epidural infiltration of the same corticoid done in lateral on contact of disco radicular conflict on scan control.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other University Hospital, Montpellier trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02151045.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing