Study of REN-1654 in Patients With Sciatica Pain

Sciatica Clinical Trial

Official title: REN-1654 in Sciatica: A Phase 2, Randomized, Double-Blind, Placebo Controlled, Multi-Center Study in Subjects With Pain Due to Lumbosacral Radiculopathy

Status Active, not recruiting

Clinical Trial Summary

The purpose of this study is to gain initial safety and efficacy data on the experimental agent REN-1654 in patients with pain that radiates down the leg(s), and is typical of sciatica (lumbosacral radiculopathy). These patients will usually have a herniated disc that is causing compression on the nerves coming out of the spinal column.

Clinical Trial Description

This is a multi-center, randomized, double-blind, placebo-controlled study to determine the efficacy and tolerability of REN-1654 in subjects with sciatica. After screening and baseline clinical assessments, subjects will be randomly assigned to receive REN 1654 100 mg or matching placebo, once daily for 3 weeks. Leg pain, back pain and other efficacy measures will be assessed at 1 and 3 weeks after initiation of treatment. A subset of patients will undergo analysis of blood levels of REN-1654 during the course of the study (pharmacokinetics). Subjects will discontinue treatment after 3 weeks and return after a further 3 weeks off therapy for a final clinical assessment 6 weeks after initiation of treatment. If a subject does not return for follow-up, an effort will be made by telephone to document their clinical status and whether other interventions have been made. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

• Herniated Disc
• Radiculopathy
• Sciatica

• NCT number: NCT00107055
• Study type: Interventional
• Source: Renovis
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: December 2003
• Completion date: April 2005