Last updated: June 21, 2023
Sponsor: Lille Catholic University
Overall Status: Active - Recruiting
Phase
4
Condition
Radiculopathy
Hernia
Treatment
Gabapentin 300mg
PLACEBO
Clinical Study ID
NCT04865042
RC-P0103
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age ≥ 18 years,
- Radiculalgia or lumboradiculalgia less than 3 months (pain of a lower limbsystematized to a radicular territory, possibly associated with lumbar pain),
- Inpatient management for a minimum of 72 hours after inclusion,
- Initial radiculalgia VAS ≥ 4 (moderate to severe pain),
- Concordant disc herniation between clinical symptomatology and imaging (CT or MRI)less than 3 months,
- Written consent signed by the patient,
- Affiliation to a social security system
- For women of childbearing age, use of effective contraception
Exclusion
Exclusion Criteria:
- Motor neurological deficit (≤ 3/5) or cauda equina syndrome (emergency surgicalindications),
- Chronic neuropathic pain in the lower limb affected by radiculalgia,
- Lumbar infiltration performed within 72 hours prior to inclusion or unable to beperformed after 72 hours,
- Patient already on Gabapentin or Pregabalin, or having taken these treatments in the 7days prior to inclusion
- Contraindication to Gabapentin (Hypersensitivity to the active substance or to any ofthe excipients: corn starch, talc, yellow iron oxide, titanium dioxide, sodium laurylsulfate, gelatin, shellac, propylene glycol, black iron oxide and potassium hydroxide)
- Creatinine clearance < 30ml/min,
- Hemodialysis patient,
- Body weight < 50kgs,
- Transplant patient
- Patient under guardianship or curatorship
- Pregnant or breastfeeding woman
Study Design
Total Participants: 144
Treatment Group(s): 2
Primary Treatment: Gabapentin 300mg
Phase: 4
Study Start date:
February 02, 2022
Estimated Completion Date:
February 28, 2025
Study Description
Connect with a study center
CH Arras-rheumatology
Arras,
FranceActive - Recruiting
CH Béthune-rheumatology
Béthune,
FranceActive - Recruiting
CHU Caen-rheumatology
Caen,
FranceActive - Recruiting
CH Dunkerque-rheumatology
Dunkerque,
FranceActive - Recruiting
CHU Rouen-rheumatology
Rouen,
FranceActive - Recruiting
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