Intervertebral Disc Disease, Lumbar Disc Disease
Conditions
Brief summary
The purpose of this study is to evaluate the safety and efficacy of SI-6603(Condoliase) in patients with lumbar disc herniation.
Interventions
DRUGCondoliase
1.25 U, intradiscal injection, one time
Sponsors
Seikagaku Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients with lumbar disc herniation (L1-L2, L2-L3, L3-L4, 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 Femoral Nerve Stretching (FNS) test for L1-L2, L2-L3, or L3-L4 and Straight Leg Raising (SLR) test. * Patients with sciatica in either leg. * Patients with no improvement from conservative treatment
Exclusion criteria
* Patients who have 2 or more lumbar disc herniations as assessed by MRI. * Patients in whom a rupture into the posterior longitudinal ligament is identified by MRI. * Patients who have undergone lumbar operation, or lumbar percutaneous nucleotomy or lumbar intradiscal therapies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Germany, Romania, Spain, United States
Participant flow
Pre-assignment details
Patients are enrolled in the study once eligibility is determined, but after enrollment, injection to the intervertebral disc may not be feasible due to anatomical reasons and patient condition during injection procedure. Therefore, Enrollment number in the Protocol Section (1011) and patients who Started the study (991) are not necessarily the same.
Participants by arm
| Arm | Count |
|---|---|
| SI-6603 Patients received a single-dose injection of SI-6603 1.25 U into an intervertebral disc. | 991 |
| Total | 991 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 4 |
| Overall Study | Lack of Efficacy | 5 |
| Overall Study | Others | 41 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 31 |
Baseline characteristics
| Characteristic | SI-6603 |
|---|---|
| Age, Customized | 49.1 years STANDARD_DEVIATION 9.69 |
| Body Mass Index (BMI) | 29.44 kg/m^2 STANDARD_DEVIATION 6.172 |
| Leg Pain (VAS) | 67.9 mm STANDARD_DEVIATION 18.48 |
| Race/Ethnicity, Customized Race Asian | 4 Participants |
| Race/Ethnicity, Customized Race Black | 103 Participants |
| Race/Ethnicity, Customized Race Other | 22 Participants |
| Race/Ethnicity, Customized Race White | 862 Participants |
| Region of Enrollment Germany | 70 participants |
| Region of Enrollment Romania | 22 participants |
| Region of Enrollment Spain | 75 participants |
| Region of Enrollment United States | 824 participants |
| Sex: Female, Male Female | 539 Participants |
| Sex: Female, Male Male | 452 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 4 / 991 |
| other Total, other adverse events | 615 / 991 |
| serious Total, serious adverse events | 36 / 991 |
Outcome results
Primary
Number of Participants With Treatment-Emergent Adverse Events (TEAE)
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.
Time frame: 26 weeks
Population: Number of Patients with at Least 1 Treatment-Emergent Adverse Event N (%)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SI-6603 | Number of Participants With Treatment-Emergent Adverse Events (TEAE) | 615 Participants |
Secondary
Worst Leg Pain as Assessed by Visual Analog Scale (VAS)
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).
Time frame: 26 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SI-6603 | Worst Leg Pain as Assessed by Visual Analog Scale (VAS) | 28.6 units on a scale | Standard Deviation 29.61 |