Lumbar Vertebra HerniaPhase 2NCT01282606
Clinical Trial to Assess Safety of SI-6603 in Patients With Lumbar Disc Herniation
A Phase 2 study testing SI-6603 in people with Lumbar Vertebra Hernia, run by Seikagaku Corporation at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety of SI-6603 in lumbar disc herniation patients. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Lumbar Vertebra Hernia
- What is being tested?
- SI-6603
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Aug 2012
- Phase
- Phase 2
- 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 lower leg.
- Patients with no improvement from pharmacotherapy or concomitant treatment with drug and nerve block.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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)
The purpose of this study is to evaluate the safety of SI-6603 in lumbar disc herniation patients.
- Conditions
- Lumbar Vertebra Hernia
- Being tested
- SI-6603
- Keywords
- Chemonucleolysis, Lumbar Vertebrae, Hernia
- Medical subject headings
- Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SI-6603Drug
SI-6603 is administrated into the nucleus pulposus of an intervertebral disc.
| Study group | Role | What they receive |
|---|---|---|
| Drug I: SI-6603 (Low) | Experimental | Not described Receives: Drug: SI-6603 |
| Drug II: SI-6603 (Middle) | Experimental | Not described Receives: Drug: SI-6603 |
| Drug III: SI-6603 (High) | Experimental | Not described Receives: Drug: SI-6603 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Measured: 52 weeks
Secondary outcomes (1)
The leg pain
Measured: At each assessment time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2011 (estimated)
- Study startDec 2007
- Primary completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Vertebra HerniaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 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
- NCT01282606
- Sponsor's protocol ID
- 6603/1121
- Status last verified
- Mar 2023
- First submitted
- 24 Jan 2011
- 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
- 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)
- ClinicalTrials.gov ID
- NCT01282606
- Acronym / sponsor ID
- 6603/1121
- Conditions
- Lumbar Vertebra Hernia
- Keywords
- Chemonucleolysis, Lumbar Vertebrae, Hernia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Seikagaku CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Aug 2012 (actual)
- First posted
- 25 Jan 2011 (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 safety of SI-6603 in lumbar disc herniation patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Drug I: SI-6603 (Low) | Experimental | Drug: SI-6603 |
| Drug II: SI-6603 (Middle) | Experimental | Drug: SI-6603 |
| Drug III: SI-6603 (High) | Experimental | Drug: SI-6603 |
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 lower leg.
- Patients with no improvement from pharmacotherapy or concomitant treatment with drug and nerve block.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| SI-6603SI-6603 is administrated into the nucleus pulposus of an intervertebral disc. | Drug | Drug I: SI-6603 (Low), Drug II: SI-6603 (Middle), Drug III: SI-6603 (High) |
Primary outcome
Adverse events
Time frame: 52 weeks
1 secondary outcome
The leg pain
Time frame: At each assessment time point
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SI-6603 in people with Lumbar Vertebra Hernia, run by Seikagaku Corporation at 1 site 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 1 site 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Adverse events (time frame: 52 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.