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
Phase 3 trial testing Non target epidural infiltration done at L3-L4 stage in Discal Sciatica in 112 participants. Status unknown.
1 March 2017
Quick facts
| Lead sponsor | University Hospital, Montpellier |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 112 |
| Start date | 1 March 2012 |
| Primary completion | 1 March 2017 |
| Estimated completion | 1 March 2017 |
| Sites | 2 locations across France |
Drugs / interventions tested
- Non target epidural infiltration done at L3-L4 stage
- Epidural infiltration on contact of disco radicular conflict
Conditions studied
- Discal Sciatica — all drugs for Discal Sciatica →
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.
-
Pain evolution on analogic visual scale (EVA) ay Day 30
Time frame: at Day 30 after infiltration
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:
- PubMed search for NCT02151045
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02151045 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Montpellier
- Last refreshed: 31 August 2015
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.
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