Trial · NCT03607838

SI-6603 (Condoliase) Study for Lumbar Disc Herniation (Discovery 6603 Study)

NCT03607838, Phase 3, Completed, Seikagaku Corporation; results first posted 2025-07-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. SI-6603 (Condoliase) Study for Lumbar Disc Herniation (Discovery 6603 Study). Trials, record NCT03607838. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03607838

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: SI-6603 (Condoliase) Study for Lumbar Disc Herniation (Discovery 6603 Study)
NCT number: NCT03607838
Status: Completed
Phases: Phase 3
Enrollment: 352 participants, actual
Lead sponsor: Seikagaku Corporation
Conditions: Lumbar Disc Herniation
Interventions: SI-6603, Sham injection
First posted: 2018-07-31
Last updated: 2025-07-24
Results first posted: 2025-07-11

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline to Week 13 in Average Worst Leg Pain Score During the Past 24 Hours Over the Previous 7 Days	baseline and 13 weeks	The primary endpoint was the change from baseline to Week 13 in average worst leg pain score during the past 24 hours over the previous 7 days, as assessed by 100 mm Visual Analog Scale (VAS). VAS is a pain assessment tool with 0 mm representing an absence of pain, and 100 mm representing the worst pain patients have ever experienced.
Secondary	Change From Baseline to Week 52 in Average Worst Leg Pain Score During the Past 24 Hours Over the Previous 7 Days	baseline and 52 weeks	One of the key secondary endpoints was the change from baseline to Week 52 in average worst leg pain score during the past 24 hours over the previous 7 days, as assessed by 100 mm Visual Analog Scale (VAS). VAS is a pain assessment tool with 0 mm representing an absence of pain, and 100 mm representing the worst pain patients have ever experienced.
Secondary	Change From Baseline to Week 13 in Herniation Volume	baseline and 13 weeks	One of the key secondary endpoints was change from baseline to Week 13 in herniation volume. Herniation volumes were assessed with MRI by a central imaging facility.
Secondary	Change From Baseline to Week 13 in Oswestry Disability Index (ODI) Score	baseline and 13 weeks	One of the key secondary endpioints was change from baseline to Week 13 in Oswestry Disability Index (ODI) score. The ODI questionnaire is designed to provide information as to how the patient's back (or leg) pain affects their ability to manage in everyday life. A higher score on the ODI indicates a more severe disability. The final index score is calculated as a percentage, with 0% indicating no disability and 100% indicating highest disability.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline to Week 13 in Average Worst Leg Pain Score During the Past 24 Hours Over the Previous 7 Days	baseline and 13 weeks	Modified intention-to-treat population	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to Week 52 in Average Worst Leg Pain Score During the Past 24 Hours Over the Previous 7 Days	baseline and 52 weeks	Modified intention-to-treat population	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to Week 13 in Herniation Volume	baseline and 13 weeks	Modified intention-to-treat population	mm^3	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to Week 13 in Oswestry Disability Index (ODI) Score	baseline and 13 weeks	Modified intention-to-treat population	percentage of disability	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline to Week 13 in Average Worst Leg Pain Score During the Past 24 Hours Over the Previous 7 Days	SI-6603	-41.7	Standard Error 2.38	units on a scale
Change From Baseline to Week 13 in Average Worst Leg Pain Score During the Past 24 Hours Over the Previous 7 Days	Sham	-34.2	Standard Error 2.36	units on a scale
Change From Baseline to Week 52 in Average Worst Leg Pain Score During the Past 24 Hours Over the Previous 7 Days	SI-6603	-51.2	Standard Error 2.40	units on a scale
Change From Baseline to Week 52 in Average Worst Leg Pain Score During the Past 24 Hours Over the Previous 7 Days	Sham	-44.7	Standard Error 2.41	units on a scale
Change From Baseline to Week 13 in Herniation Volume	SI-6603	-103.8	Standard Error 10.74	mm^3
Change From Baseline to Week 13 in Herniation Volume	Sham	-78.1	Standard Error 10.79	mm^3
Change From Baseline to Week 13 in Oswestry Disability Index (ODI) Score	SI-6603	-29.6	Standard Error 1.38	percentage of disability
Change From Baseline to Week 13 in Oswestry Disability Index (ODI) Score	Sham	-25.4	Standard Error 1.38	percentage of disability

Source ClinicalTrials.gov

Participant flow10

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	SI-6603	176
Overall Study	STARTED	Sham	176
Overall Study	Injected	SI-6603	169
Overall Study	Injected	Sham	172
Overall Study	Evaluated Week 13	SI-6603	156
Overall Study	Evaluated Week 13	Sham	155
Overall Study	COMPLETED	SI-6603	135
Overall Study	COMPLETED	Sham	130
Overall Study	NOT COMPLETED	SI-6603	41
Overall Study	NOT COMPLETED	Sham	46

Source ClinicalTrials.gov

Adverse events40

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Magnetic resonance imaging spinal abnormal	Investigations	SI-6603	47	167
other	Magnetic resonance imaging spinal abnormal	Investigations	Sham	16	174
other	Back pain	Musculoskeletal and connective tissue disorders	SI-6603	32	167
other	Back pain	Musculoskeletal and connective tissue disorders	Sham	22	174
other	Pain in extremity	Musculoskeletal and connective tissue disorders	SI-6603	18	167
other	Pain in extremity	Musculoskeletal and connective tissue disorders	Sham	13	174
other	Spinal X-ray abnormal	Investigations	SI-6603	13	167
other	Spinal X-ray abnormal	Investigations	Sham	3	174
other	COVID-19	Infections and infestations	SI-6603	11	167
other	COVID-19	Infections and infestations	Sham	17	174

1 to 10 of 40Source ClinicalTrials.gov

See all 40 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	SI-6603	1	167
Total, all-cause mortality	Sham	0	174
Total, other adverse events	SI-6603	91	167
Total, other adverse events	Sham	62	174
Total, serious adverse events	SI-6603	7	167
Total, serious adverse events	Sham	6	174

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
39168360	DERIVED	PubMed
40066868	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
SI-6603 vs Sham: deaths from any cause	Trial comparisons
SI-6603 vs Sham: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03607838

GET https://conductscience.org/api/trials/v1/NCT03607838/events?page=2

API reference For AI assistants