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Enzyme

SI-6603 for Slipped Disc

Phase 3
Waitlist Available
Research Sponsored by Seikagaku Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks
Awards & highlights

Study Summary

This trial will test whether a single injection of SI-6603 into the discs of people with lumbar disc herniation is effective.

Eligible Conditions
  • Slipped Disc

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Average worst leg pain score during the past 24 hours over the previous 7 days
Herniation volume assessed by MRI
Oswestry Disability Index (ODI) score

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SI-6603Experimental Treatment1 Intervention
Group II: Sham injectionPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SI-6603
2007
Completed Phase 3
~570

Find a Location

Who is running the clinical trial?

Seikagaku CorporationLead Sponsor
13 Previous Clinical Trials
4,160 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other studies has SI-6603 been involved in?

"As of now, there is only 1 clinical trial underway for SI-6603. That 1 trial is currently in Phase 3. Even though most studies for SI-6603 are conducted in Sheffield, Alabama, there are a total of 93 locations running trials for this medication."

Answered by AI

Are new patients being registered for this experiment?

"The clinical trial, which was originally posted on May 30th, 2018, is not currently seeking patients according to information on clinicaltrials.gov. Although this study is not looking for candidates, there are 203 other studies that are."

Answered by AI

Do we have a solid presence of this trial in Canada?

"There are a total of 61 running clinical trials for this study. These trials are being conducted at locations like the Clinical Inquest Center Ltd in Beavercreek, St. Louis Pain Consultants in Chesterfield, Tulane University School of Medicine in New Orleans, and 58 other sites."

Answered by AI

Does this type of research exist?

"As of now, only one trial for SI-6603 is ongoing, covering 85 cities in a single nation. The first trial for SI-6603 occurred in 2018. That year, Seikagaku Corporation ran the 320-person Phase 3 clinical trial which completed the drug approval process. In the years since 2018, 39 more trials have taken place."

Answered by AI

Can middle-aged individuals participate in this research?

"Eligibility requirements for this particular trial state that patients must be between 30 and 70 years old. If the patient does not meet this age requirement, there are 16 other trials that might be a better fit. If the patient is over 65, there are 172 other potential trials."

Answered by AI

Who else is applying?

What state do they live in?
New Hampshire
Florida
How old are they?
65+
18 - 65
What site did they apply to?
Holy Cross Medical Group
Interventional Spine Medicine
AMPM Research Clinic
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+

How responsive is this trial?

Typically responds via
Email
~52 spots leftby Apr 2025