Lumbar Vertebra HerniaPhase 2/3NCT00634946

SI-6603 Versus Placebo in Patients With Lumbar Disc Herniation

A Phase 2/3 study testing SI-6603 in people with Lumbar Vertebra Hernia, run by Seikagaku Corporation at 8 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine whether SI-6603 is effective in the treatment of lumbar disc herniation. Read more about this study

Who is it for?: Ages 20 to 70 years
Conditions the study is for: Lumbar Vertebra Hernia
What is being tested?: SI-6603
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 195 participants
Where: 8 sitesJapan
Study dates: Jan 2008to Aug 2010
Phase: Phase 2/3
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 20 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

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

Japan8 sites

Chubu Area
Chūbu
Chugoku Area
Chugoku
Hokkaido Area
Hokkaido
Kansai Area
Kansai
Kanto Area
Kanto
Kyushu Area
Kyushu
Shikoku Area
Shikoku
Tohoku Area
Tōhoku

Other trials in Japan

About this study

Official title: A Multicenter, Randomized, Double-blind Recommended Dose-finding Study of SI-6603 in Patients With Lumbar Disc Herniation (Phase II/III Study)

The purpose of this study is to determine whether SI-6603 is effective in the treatment of lumbar disc herniation.

Conditions: Lumbar Vertebra Hernia
Being tested: SI-6603, Placebo
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.
PlaceboDrug
Placebo is administrated into the nucleus pulposus of an intervertebral disc.

Study groups in NCT00634946
Study group	Role	What they receive
I	Experimental	Not described Receives: Drug: SI-6603
II	Experimental	Not described Receives: Drug: SI-6603
III	Experimental	Not described Receives: Drug: SI-6603
IV	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in leg pain from baseline.
Measured: 13 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.

Jan 2008Aug 2010

First posted13 Mar 2008 (estimated)
Study startJan 2008
Primary completionNov 2009
Study completionAug 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 195 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00634946
Sponsor's protocol ID: 6603/1021
Other IDs: 6603/1021
Status last verified: Mar 2023
First submitted: 27 Feb 2008
Last updated: 23 Mar 2023
Results posted: No

Publications

Matsuyama Y, Chiba K, Iwata H, Seo T, Toyama Y. A multicenter, randomized, double-blind, dose-finding study of condoliase in patients with lumbar disc herniation. J Neurosurg Spine. 2018 May;28(5):499-511. doi: 10.3171/2017.7.SPINE161327. Epub 2018 Feb 9.
PubMed 29424676

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, Randomized, Double-blind Recommended Dose-finding Study of SI-6603 in Patients With Lumbar Disc Herniation (Phase II/III Study)
ClinicalTrials.gov ID: NCT00634946
Acronym / sponsor ID: 6603/1021
Conditions: Lumbar Vertebra Hernia
Keywords: Chemonucleolysis, Lumbar Vertebrae, Hernia
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 195 participants (actual)
Lead sponsor: Seikagaku CorporationIndustry (pharma, biotech, devices)
Study start: Jan 2008
Primary completion: Nov 2009 (actual)
Study completion: Aug 2010 (actual)
First posted: 13 Mar 2008 (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 determine whether SI-6603 is effective in the treatment of lumbar disc herniation.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
I	Experimental	Drug: SI-6603
II	Experimental	Drug: SI-6603
III	Experimental	Drug: SI-6603
IV	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 20 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	I, II, III
PlaceboPlacebo is administrated into the nucleus pulposus of an intervertebral disc.	Drug	IV

Primary outcome

Changes in leg pain from baseline.
Time frame: 13 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.
Derived from this study: PubMed 29424676Matsuyama Y, Chiba K, Iwata H, Seo T, Toyama Y. A multicenter, randomized, double-blind, dose-finding study of condoliase in patients with lumbar disc herniation. J Neurosurg Spine. 2018 May;28(5):499-511. doi: 10.3171/2017.7.SPINE161327. Epub 2018 Feb 9.

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.

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing SI-6603 in people with Lumbar Vertebra Hernia, run by Seikagaku Corporation at 8 sites in Japan.

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 8 sites in Japan. 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 combined 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.

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?

Changes in leg pain from baseline. (time frame: 13 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00634946, which also lists 1 linked publication.

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; AzTrials last refreshed its copy on 7 Nov 2026.