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

NCT02421601 | Completed Phase 3 Results

• 1 other identifier: 6603/1132
• Study Type: interventional
• Target: 1,011
• Locations: 4 countries
• Sites: 48

Brief Summary

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

Conditions

Intervertebral Disc Disease; Lumbar Disc Disease

Outcome Measures

Primary Outcomes (1)

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

  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.

  26 weeks

Secondary Outcomes (1)

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

  26 weeks

Study Arms (1)

SI-6603

EXPERIMENTAL

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

Drug: Condoliase

Interventions

Condoliase DRUG

1.25 U, intradiscal injection, one time

SI-6603

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seikagaku Corporation: lead

Study Sites (48)

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Mobile, Alabama, United States

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Phoenix, Arizona, United States

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Gold River, California, United States

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Laguna Hills, California, United States

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Los Gatos, California, United States

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Riverside, California, United States

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Temecula, California, United States

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Greenwood Village, Colorado, United States

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Clermont, Florida, United States

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Hialeah, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Miami Gardens, Florida, United States

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Naples, Florida, United States

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Pinellas Park, Florida, United States

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Sarasota, Florida, United States

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South Miami, Florida, United States

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St. Petersburg, Florida, United States

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Winter Park, Florida, United States

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Marietta, Georgia, United States

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Newnan, Georgia, United States

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Bloomington, Illinois, United States

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Carmel, Indiana, United States

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Shreveport, Louisiana, United States

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City of Saint Peters, Missouri, United States

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Hartsdale, New York, United States

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Eugene, Oregon, United States

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Charleston, South Carolina, United States

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Plano, Texas, United States

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Sandy City, Utah, United States

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Eichstätt, Bavaria, Germany

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Frankfurt am Main, Hesse, Germany

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Cologne, North Rhine-Westphalia, Germany

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Göppingen, Stuttgart, Germany

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Berlin, Germany

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Hamburg, Germany

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Brasov, Romania

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Bucharest, Romania

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Sibiu, Romania

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Cadiz, Andalusia, Spain

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Palma de Mallorca, Balearic Islands, Spain

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Badalona, Barcelona, Spain

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Terrassa, Barcelona, Spain

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Valladolid, Castille and León, Spain

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Alcorcón, Madrid, Spain

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Barcelona, Spain

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Ourense, Spain

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Valencia, Spain

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MeSH Terms

Conditions

Intervertebral disc disease

Results Point of Contact

• Title: Clinical Development Department
• Organization: Seikagaku Corporation

kyoichi.osano@seikagaku.co.jp

(81)3-5220-8948

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2015
• First Posted: April 20, 2015
• Study Start: March 1, 2015
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: March 23, 2023
• Results First Posted: November 11, 2021

Record last verified: 2023-03

Locations

US (30); RO (3); ES (9); DE (6)