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Completed

NCT Number: NCT02421601

A Study of SI-6603 in Patients With Lumbar Disc Herniation

The purpose of this study is to evaluate the safety and efficacy of SI-6603(Condoliase) in patients with lumbar disc herniation.

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Key information

Conditions

Intervertebral Disc Disease Lumbar Disc Disease

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Eichstätt, Bavaria, Germany

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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 (L1-L2, L2-L3, L3-L4, 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 Femoral Nerve Stretching (FNS) test for L1-L2, L2-L3, or L3-L4 and Straight Leg Raising (SLR) test.
  • Patients with sciatica in either leg.
  • Patients with no improvement from conservative treatment

Exclusion criteria

  • Patients who have 2 or more lumbar disc herniations as assessed by MRI.
  • Patients in whom a rupture into the posterior longitudinal ligament is identified by MRI.
  • Patients who have undergone lumbar operation, or lumbar percutaneous nucleotomy or lumbar intradiscal therapies

Treatment and study plan

Condoliase

Drug

1.25 U, intradiscal injection, one time

Primary outcomes

  1. Number of Participants With Treatment-Emergent Adverse Events (TEAE)

    Time frame: 26 weeks

    A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that began or that worsened in severity after the investigational drug had been administered. All AEs, including intercurrent illnesses and regardless of the relationship to investigational drug, occurring during the study were documented from the signing of the informed consent form until completion of final visit. Concomitant illnesses, which existed before entry into the study, were not considered AEs unless they worsened during the treatment period. All AEs, regardless of the source of identification (e.g., physical examination, laboratory assessment, or reported by patient), had to be documented.

Secondary outcomes

  1. Worst Leg Pain as Assessed by Visual Analog Scale (VAS)

    Time frame: 26 weeks

    Worst leg pain intensity during the past 24 hours assessed by Visual Analog Scale (VAS). Scores are recorded by making a handwritten mark on a 100 mm line that represents a continuum between "no pain" (0 mm) and "extreme pain" (100 mm).

Sponsors and collaborators

Lead sponsor

Seikagaku Corporation

Industry

Registry information

Official study title

A Multicenter, Open-label Study of SI 6603 in Patients With Lumbar Disc Herniation (Phase III)

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Apr 20, 2015
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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