Trial Outcomes & Findings for A Study of SI-6603 in Patients With Lumbar Disc Herniation (NCT NCT02421601)
NCT ID: NCT02421601
Last Updated: 2023-03-23
Results Overview
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.
COMPLETED
PHASE3
1011 participants
26 weeks
2023-03-23
Participant Flow
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.
Participant milestones
| Measure |
SI-6603
Patients received a single-dose injection of SI-6603 1.25 U into an intervertebral disc.
|
|---|---|
|
Overall Study
STARTED
|
991
|
|
Overall Study
COMPLETED
|
909
|
|
Overall Study
NOT COMPLETED
|
82
|
Reasons for withdrawal
| Measure |
SI-6603
Patients received a single-dose injection of SI-6603 1.25 U into an intervertebral disc.
|
|---|---|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Lack of Efficacy
|
5
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Withdrawal by Subject
|
31
|
|
Overall Study
Others
|
41
|
Baseline Characteristics
Number analyzed differs from overall population, due to data availability for analysis.
Baseline characteristics by cohort
| Measure |
SI-6603
n=991 Participants
Patients received a single-dose injection of SI-6603 1.25 U into an intervertebral disc.
|
|---|---|
|
Age, Customized
|
49.1 years
STANDARD_DEVIATION 9.69 • n=991 Participants
|
|
Sex: Female, Male
Female
|
539 Participants
n=991 Participants
|
|
Sex: Female, Male
Male
|
452 Participants
n=991 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
4 Participants
n=991 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
862 Participants
n=991 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
103 Participants
n=991 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
22 Participants
n=991 Participants
|
|
Region of Enrollment
United States
|
824 participants
n=991 Participants
|
|
Region of Enrollment
Germany
|
70 participants
n=991 Participants
|
|
Region of Enrollment
Spain
|
75 participants
n=991 Participants
|
|
Region of Enrollment
Romania
|
22 participants
n=991 Participants
|
|
Body Mass Index (BMI)
|
29.44 kg/m^2
STANDARD_DEVIATION 6.172 • n=989 Participants • Number analyzed differs from overall population, due to data availability for analysis.
|
|
Leg Pain (VAS)
|
67.9 mm
STANDARD_DEVIATION 18.48 • n=990 Participants • Number analyzed differs from overall population, due to data availability for analysis.
|
PRIMARY outcome
Timeframe: 26 weeksPopulation: Number of Patients with at Least 1 Treatment-Emergent Adverse Event N (%)
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.
Outcome measures
| Measure |
SI-6603
n=991 Participants
Patients received a single-dose injection of SI-6603 1.25 U into an intervertebral disc.
|
|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAE)
|
615 Participants
|
SECONDARY outcome
Timeframe: 26 weeksWorst 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).
Outcome measures
| Measure |
SI-6603
n=900 Participants
Patients received a single-dose injection of SI-6603 1.25 U into an intervertebral disc.
|
|---|---|
|
Worst Leg Pain as Assessed by Visual Analog Scale (VAS)
|
28.6 units on a scale
Standard Deviation 29.61
|
Adverse Events
SI-6603
Serious adverse events
| Measure |
SI-6603
n=991 participants at risk
Patients received a single-dose injection of SI-6603 1.25 U into an intervertebral disc.
|
|---|---|
|
Infections and infestations
Pneumonia
|
0.10%
1/991 • 26 Weeks
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.10%
1/991 • 26 Weeks
|
|
Infections and infestations
Urosepsis
|
0.10%
1/991 • 26 Weeks
|
|
Infections and infestations
Wound infection
|
0.10%
1/991 • 26 Weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.10%
1/991 • 26 Weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.10%
1/991 • 26 Weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease recurrent
|
0.10%
1/991 • 26 Weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine adenocarcinoma
|
0.10%
1/991 • 26 Weeks
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.10%
1/991 • 26 Weeks
|
|
Psychiatric disorders
Drug dependence
|
0.10%
1/991 • 26 Weeks
|
|
Psychiatric disorders
Panic attack
|
0.10%
1/991 • 26 Weeks
|
|
Nervous system disorders
Transient ischaemic attack
|
0.20%
2/991 • 26 Weeks
|
|
Nervous system disorders
Cerebral ischaemia
|
0.10%
1/991 • 26 Weeks
|
|
Nervous system disorders
Sciatica
|
0.10%
1/991 • 26 Weeks
|
|
Nervous system disorders
Syncope
|
0.10%
1/991 • 26 Weeks
|
|
Cardiac disorders
Acute myocardial infarction
|
0.10%
1/991 • 26 Weeks
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.10%
1/991 • 26 Weeks
|
|
Vascular disorders
Hypertensive crisis
|
0.10%
1/991 • 26 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.20%
2/991 • 26 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.10%
1/991 • 26 Weeks
|
|
Gastrointestinal disorders
Ascites
|
0.10%
1/991 • 26 Weeks
|
|
Gastrointestinal disorders
Colitis
|
0.10%
1/991 • 26 Weeks
|
|
Hepatobiliary disorders
Cholecystitis
|
0.10%
1/991 • 26 Weeks
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.10%
1/991 • 26 Weeks
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.30%
3/991 • 26 Weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.10%
1/991 • 26 Weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.10%
1/991 • 26 Weeks
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.10%
1/991 • 26 Weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.10%
1/991 • 26 Weeks
|
|
Musculoskeletal and connective tissue disorders
Paraspinal abscess
|
0.10%
1/991 • 26 Weeks
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.10%
1/991 • 26 Weeks
|
|
General disorders
Non-cardiac chest pain
|
0.20%
2/991 • 26 Weeks
|
|
General disorders
Pain
|
0.10%
1/991 • 26 Weeks
|
|
Investigations
Nuclear magnetic resonance imaging abnormal
|
0.10%
1/991 • 26 Weeks
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.20%
2/991 • 26 Weeks
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.20%
2/991 • 26 Weeks
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.10%
1/991 • 26 Weeks
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.10%
1/991 • 26 Weeks
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.10%
1/991 • 26 Weeks
|
Other adverse events
| Measure |
SI-6603
n=991 participants at risk
Patients received a single-dose injection of SI-6603 1.25 U into an intervertebral disc.
|
|---|---|
|
Investigations
Nuclear magnetic resonance imaging spinal abnormal
|
20.8%
206/991 • 26 Weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.9%
158/991 • 26 Weeks
|
|
Investigations
Spinal X-ray abnormal
|
7.7%
76/991 • 26 Weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.4%
54/991 • 26 Weeks
|
|
Investigations
C-reactive protein increased
|
4.0%
40/991 • 26 Weeks
|
|
Nervous system disorders
Sciatica
|
2.7%
27/991 • 26 Weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.5%
25/991 • 26 Weeks
|
|
Infections and infestations
Nasopharyngitis
|
2.0%
20/991 • 26 Weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.7%
17/991 • 26 Weeks
|
|
Gastrointestinal disorders
Nausea
|
1.5%
15/991 • 26 Weeks
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
1.4%
14/991 • 26 Weeks
|
|
Nervous system disorders
Headache
|
1.4%
14/991 • 26 Weeks
|
|
Infections and infestations
Sinusitis
|
1.3%
13/991 • 26 Weeks
|
|
Investigations
White blood cell count increased
|
1.2%
12/991 • 26 Weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.1%
11/991 • 26 Weeks
|
|
Investigations
Blood triglycerides increased
|
1.0%
10/991 • 26 Weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
1.0%
10/991 • 26 Weeks
|
|
Infections and infestations
Influenza
|
1.0%
10/991 • 26 Weeks
|
Additional Information
Clinical Development Department
Seikagaku Corporation
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER