Trial · NCT02421601
A Study of SI-6603 in Patients With Lumbar Disc Herniation
NCT02421601, Phase 3, Completed, Seikagaku Corporation; results first posted 2021-11-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of SI-6603 in Patients With Lumbar Disc Herniation. Trials, record NCT02421601. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02421601
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of SI-6603 in Patients With Lumbar Disc Herniation
- NCT number
- NCT02421601
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,011 participants, actual
- Lead sponsor
- Seikagaku Corporation
- Conditions
- Intervertebral Disc Disease, Lumbar Disc Disease
- Interventions
- Condoliase
- First posted
- 2015-04-20
- Last updated
- 2023-03-23
- Results first posted
- 2021-11-11
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAE) | 26 weeks | A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that began or that worsened in severity after the investigational drug had been administered. All AEs, including intercurrent illnesses and regardless of the relationship to investigational drug, occurring during the study were documented from the signing of the informed consent form until completion of final visit. Concomitant illnesses, which existed before entry into the study, were not considered AEs unless they worsened during the treatment period. All AEs, regardless of the source of identification (e.g., physical examination, laboratory assessment, or reported by patient), had to be documented. |
| Secondary | Worst Leg Pain as Assessed by Visual Analog Scale (VAS) | 26 weeks | Worst leg pain intensity during the past 24 hours assessed by Visual Analog Scale (VAS). Scores are recorded by making a handwritten mark on a 100 mm line that represents a continuum between "no pain" (0 mm) and "extreme pain" (100 mm). |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Events (TEAE) | 26 weeks | Number of Patients with at Least 1 Treatment-Emergent Adverse Event N (%) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Worst Leg Pain as Assessed by Visual Analog Scale (VAS) | 26 weeks | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAE) | SI-6603 | 615 | Participants | ||
| Worst Leg Pain as Assessed by Visual Analog Scale (VAS) | SI-6603 | 28.6 | Standard Deviation 29.61 | units on a scale |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SI-6603 | 991 | |
| Overall Study | COMPLETED | SI-6603 | 909 | |
| Overall Study | NOT COMPLETED | SI-6603 | 82 |
Source ClinicalTrials.gov
Adverse events57
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 | Events |
|---|---|---|---|---|---|---|
| other | Nuclear magnetic resonance imaging spinal abnormal | Investigations | SI-6603 | 206 | 991 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | SI-6603 | 158 | 991 | |
| other | Spinal X-ray abnormal | Investigations | SI-6603 | 76 | 991 | |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | SI-6603 | 54 | 991 | |
| other | C-reactive protein increased | Investigations | SI-6603 | 40 | 991 | |
| other | Sciatica | Nervous system disorders | SI-6603 | 27 | 991 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | SI-6603 | 25 | 991 | |
| other | Nasopharyngitis | Infections and infestations | SI-6603 | 20 | 991 | |
| other | Muscle spasms | Musculoskeletal and connective tissue disorders | SI-6603 | 17 | 991 | |
| other | Nausea | Gastrointestinal disorders | SI-6603 | 15 | 991 |
1 to 10 of 57Source ClinicalTrials.gov
See all 57 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SI-6603 | 4 | 991 |
| Total, other adverse events | SI-6603 | 615 | 991 |
| Total, serious adverse events | SI-6603 | 36 | 991 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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/NCT02421601
GET https://conductscience.org/api/trials/v1/NCT02421601/events?page=2