Intervertebral Disc DiseasePhase 3NCT02421601
A Study of SI-6603 in Patients With Lumbar Disc Herniation
A Phase 3 study testing Condoliase in people with Intervertebral Disc Disease and Lumbar Disc Disease, run by Seikagaku Corporation at 48 sites in 4 countries.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of SI-6603(Condoliase) in patients with lumbar disc herniation. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Intervertebral Disc Disease, Lumbar Disc Disease
- What is being tested?
- Condoliase
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,011 participants
- Where
- 48 sitesin 4 countries
- Study dates
- Mar 2015to Feb 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
48 sites in 4 countries.
48 sites in 4 countries
United States30 sites
Study site
Bloomington, Illinois
Study site
Carmel, Indiana
Study site
Charleston, South Carolina
Study site
City of Saint Peters, Missouri
Study site
Clermont, Florida
Study site
Eugene, Oregon
Study site
Gold River, California
Study site
Greenwood Village, Colorado
Study site
Hartsdale, New York
Study site
Hialeah, Florida
Study site
Jacksonville, Florida
Study site
Laguna Hills, California
Study site
Los Gatos, California
Study site
Marietta, Georgia
Study site
Miami, Florida
Study site
Miami Gardens, Florida
Study site
Mobile, Alabama
Study site
Naples, Florida
Study site
Newnan, Georgia
Study site
Phoenix, Arizona
Study site
Pinellas Park, Florida
Study site
Plano, Texas
Study site
Riverside, California
Study site
Sandy City, Utah
Study site
Sarasota, Florida
Study site
Shreveport, Louisiana
Study site
South Miami, Florida
Study site
St. Petersburg, Florida
Study site
Temecula, California
Study site
Winter Park, Florida
Spain9 sites
Study site
Alcorcón, Madrid
Study site
Badalona, Barcelona
Study site
Barcelona
Study site
Cadiz, Andalusia
Study site
Ourense
Study site
Palma de Mallorca, Balearic Islands
Study site
Terrassa, Barcelona
Study site
Valencia
Study site
Valladolid, Castille and León
Germany6 sites
Study site
Berlin
Study site
Cologne, North Rhine-Westphalia
Study site
Eichstätt, Bavaria
Study site
Frankfurt am Main, Hesse
Study site
Göppingen, Stuttgart
Study site
Hamburg
About this study
Official title: A Multicenter, Open-label Study of SI 6603 in Patients With Lumbar Disc Herniation (Phase III)
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
- Being tested
- Condoliase
- Medical subject headings
- Intervertebral disc disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CondoliaseDrug
1.25 U, intradiscal injection, one time
| Study group | Role | What they receive |
|---|---|---|
| SI-6603 | Experimental | SI-6603: SI-6603 is administrated into the nucleus pulposus of the intervertebral disc Receives: Drug: Condoliase |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 26 weeks
Secondary outcomes (1)
Worst Leg Pain as Assessed by Visual Analog Scale (VAS)
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).
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Intervertebral Disc DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,011 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seikagaku Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02421601
- Sponsor's protocol ID
- 6603/1132
- Status last verified
- Mar 2023
- First submitted
- 6 Apr 2015
- Last updated
- 23 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label Study of SI 6603 in Patients With Lumbar Disc Herniation (Phase III)
- ClinicalTrials.gov ID
- NCT02421601
- Acronym / sponsor ID
- 6603/1132
- Conditions
- Intervertebral Disc Disease, Lumbar Disc Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,011 participants (actual)
- Lead sponsor
- Seikagaku CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 20 Apr 2015 (estimated)
- Results
- Posted 11 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and efficacy of SI-6603(Condoliase) in patients with lumbar disc herniation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SI-6603 | Experimental | Drug: CondoliaseSI-6603: SI-6603 is administrated into the nucleus pulposus of the intervertebral disc |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Condoliase1.25 U, intradiscal injection, one time | Drug | SI-6603 |
Primary outcome
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.
1 secondary outcome
Worst Leg Pain as Assessed by Visual Analog Scale (VAS)
Time frame: 26 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
48 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Condoliase in people with Intervertebral Disc Disease and Lumbar Disc Disease, run by Seikagaku Corporation at 48 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in United States, Spain, Germany, Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Emergent Adverse Events (TEAE) (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023.