Intervertebral Disc DiseasePhase 3NCT01941563
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 32 sites in United States.
Trial summary
The purpose of this study is to evaluate the efficacy and safety 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?
- Yes, some participants may receive a placebo
- How many people
- 385 participants
- Where
- 32 sitesUnited States
- Study dates
- Sep 2013to Aug 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 (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 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 received spinal injection, epidural injection, nerve block within 3 weeks prior to the time of informed consent.
- Patients who have undergone lumbar operation, or lumbar percutaneous nucleotomy or lumbar intradiscal therapies
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
United States32 sites
Study site
Bloomington, Illinois
Study site
Carmel, Indiana
Study site
Charleston, South Carolina
Study site
City of Saint Peters, Missouri
Study site
Dallas, Texas
Study site
Denver, Colorado
Study site
Edmonds, Washington
Study site
Eugene, Oregon
Study site
Gold River, California
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
Merritt Island, Florida
Study site
Miami, Florida
Study site
Murrieta, California
Study site
Naples, Florida
Study site
Newnan, Georgia
Study site
North Miami Beach, Florida
Study site
Orlando, Florida
Study site
Phoenix, Arizona
Study site
Pinellas Park, Florida
Study site
Riverside, California
Study site
Sandy City, Utah
Study site
Sarasota, Florida
Study site
Shreveport, Louisiana
Study site
St. Petersburg, Florida
Study site
State College, Pennsylvania
Study site
Sunrise, Florida
Study site
Winter Park, Florida
About this study
The purpose of this study is to evaluate the efficacy and safety of SI-6603 (condoliase) in patients with lumbar disc herniation.
- Conditions
- Intervertebral Disc Disease, Lumbar Disc Disease
- Being tested
- Condoliase, placebo
- 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
1.25U, intradiscal injection, one time
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| SI-6603 | Experimental | SI-6603 is administrated into the nucleus pulposus of the intervertebral disc Receives: Drug: Condoliase |
| Control | Sham comparator | Sham injection Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leg pain
Assessed by Visual Analog Scale (VAS)
Measured: 13 weeks
Secondary outcomes (1)
Responder rate evaluation
Assessed by leg pain (VAS), Oswestry Disability Index disability questionnaire, neurologic status (motor, sensory, reflexes), and no treatment failure
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionNov 2015
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 385 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
- NCT01941563
- Sponsor's protocol ID
- 6603/1131
- Other IDs
- 6603/1131
- Status last verified
- Mar 2023
- First submitted
- 4 Sep 2013
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
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 Study of SI-6603 in Patients With Lumbar Disc Herniation
- ClinicalTrials.gov ID
- NCT01941563
- Acronym / sponsor ID
- 6603/1131
- Conditions
- Intervertebral Disc Disease, Lumbar Disc Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 385 participants (actual)
- Lead sponsor
- Seikagaku CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 13 Sep 2013 (estimated)
- Results
- Not posted in the source record
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 efficacy and safety of SI-6603 (condoliase) in patients with lumbar disc herniation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SI-6603 | Experimental | Drug: CondoliaseSI-6603 is administrated into the nucleus pulposus of the intervertebral disc |
| Control | Sham comparator | Drug: placeboSham injection |
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 (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 leg.
- Patients with no improvement from conservative treatment
Key exclusion criteria (4 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 received spinal injection, epidural injection, nerve block within 3 weeks prior to the time of informed consent.
- 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 |
|---|---|---|
| Condoliase1.25U, intradiscal injection, one time | Drug | SI-6603 |
| placebo | Drug | Control |
Primary outcome
Leg pain
Time frame: 13 weeks
Assessed by Visual Analog Scale (VAS)
1 secondary outcome
Responder rate evaluation
Time frame: 13 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
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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.
32 sites in 1 country: 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 32 sites in United States.
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 4 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 32 sites in United States. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Leg pain (time frame: 13 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.