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Completed

NCT Number: NCT01282606

Clinical Trial to Assess Safety of SI-6603 in Patients With Lumbar Disc Herniation

The purpose of this study is to evaluate the safety of SI-6603 in lumbar disc herniation patients.

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Key information

Conditions

Lumbar Vertebra Hernia Hernia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

SKK

Encinitas, California, 92024, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with lumbar disc herniation (L4-L5 or L5-S1) as assessed by MRI and clinical symptoms corresponding to position of the impaired nerve root.
  • Patients assessed as positive in the SLR test.
  • Patients with sciatica in either lower leg.
  • Patients with no improvement from pharmacotherapy or concomitant treatment with drug and nerve block.

Exclusion criteria

  • Patients who have 2 or more lumbar disc herniations as assessed by MRI.
  • Patients with "extrusion-type" or "sequestration-type" herniation in whom a rupture into the posterior longitudinal ligament is identified by MRI.
  • Patients who have received nerve block within 3 weeks before screening.
  • Patients who have undergone lumbar operation, chemonucleolysis, or percutaneous nucleotomy.

Treatment and study plan

SI-6603

Drug

SI-6603 is administrated into the nucleus pulposus of an intervertebral disc.

Primary outcomes

  1. Adverse events

    Time frame: 52 weeks

Secondary outcomes

  1. The leg pain

    Time frame: At each assessment time point

Sponsors and collaborators

Lead sponsor

Seikagaku Corporation

Industry

Registry information

Official study title

An Open Label, Non-randomized Dose-escalation Study to Assess Safety and Tolerability of SI-6603 in Patients With Lumbar Disc Herniation (Phase II Study)

Important dates

Study start
2007
Primary completion
2012
First posted
Jan 25, 2011
Registry last updated
Mar 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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