Safety and Efficacy of SX600 Administered by Lumbosacral... | NCT03952377

Label	Type	Description	Intervention Names
0.9% Sodium Chloride for Injection	Placebo Comparator		Drug: Placebo
12.5 mg SX600	Experimental	Low Dose	Drug: SX600
25.0 mg SX600	Experimental	High Dose	Drug: SX600

Name	Type	Description	Arm Group Labels	Other Names
SX600	Drug	Transforaminal Epidural Injection	12.5 mg SX600 25.0 mg SX600

Measure	Description	Time Frame
The Proportion of Subjects With a 50% or Greater Improvement in Mean Worst Daily Leg Pain (Responders).		Baseline to 60 days

Measure	Description	Time Frame
The Proportion of Subjects Who Are Responders (Defined as Having a 50% or Greater Improvement in Mean Worst Daily Leg Pain)		Baseline to 14, 30, 60, 90, 120, 150, and 180 days
Change in Functional Outcomes as Measured by Patient's Global Impression of Change

Measure	Description	Time Frame
Proportion of Subjects Who Reduce Utilization of Supportive Health Services From Baseline, as Reported in Patient Diary		From baseline through 180 days

Eligibility Module

Eligibility Criteria

Main Inclusion Criteria:

Adult aged 18 to 65 years, capable of providing informed consent, capable of complying with the outcome instruments, and meeting the attendance requirements for review as defined in the study
Presenting with a history of radicular pain of duration of 4 weeks to 6 months, having failed conservative therapy.
Mean Worst Daily Leg Pain score of ≥5.0 and ≤9.0
Women of child-bearing potential must use a medically accepted method of contraception for the duration of the study plus 30 days and register a negative pregnancy test prior to dosing

Main Exclusion Criteria:

Documented history of allergy or intolerance to components of the Investigational Medicinal Product, relevant radiologic contrast media, or local anaesthetics
Is pregnant or lactating
Has been taking corticosteroid medications routinely in the past 6 months or has received an epidural corticosteroid injection within 12 weeks of screening
Has a BMI greater than 40 kg/m2
Has radiological evidence of clinically significant foraminal stenosis at L4-L5 or L5-S1 or of clinically significant spinal stenosis, or spondylolisthesis (Grade 2 or higher). (Note, asymptomatic foraminal stenosis at other spinal levels is not excluded).
Has Diabetes Mellitus (Type 1 or Type 2)- prior confirmed HbA1c or OGTT
Has a history of significant leg pain unrelated to disc herniation that would significantly compromise assessment of back or leg radicular pain
Has had lumbar back surgery
Has received an implantable device for pain management

Name	Affiliation	Role
Willem Volschenk	Genesis Research Services	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Research Site 03		Adelaide			Australia
Research Site 12

ID	Title	Description
FG000	0.9% Sodium Chloride for Injection	Placebo: Transforaminal Epidural Injection
FG001	12.5 mg SX600	Low Dose SX600: Transforaminal Epidural Injection

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 17, 2020	Dec 7, 2023

ID	Title	Description
BG000	0.9% Sodium Chloride for Injection	Placebo: Transforaminal Epidural Injection
BG001	12.5 mg SX600	Low Dose SX600: Transforaminal Epidural Injection
BG002	25.0 mg SX600	High Dose SX600: Transforaminal Epidural Injection
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG00018 BG00121 BG00217 BG00356

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

The Proportion of Subjects With a 50% or Greater Improvement in Mean Worst Daily Leg Pain (Responders).

mITT population, denominator (# of participants analyzed) is number of non-missing values at 60 days

Posted

Count of Participants

Participants

Baseline to 60 days

ID	Title	Description
OG000	0.9% Sodium Chloride for Injection	Placebo: Transforaminal Epidural Injection
OG001	12.5 mg SX600	Low Dose SX600: Transforaminal Epidural Injection
OG002	25.0 mg SX600	High Dose SX600: Transforaminal Epidural Injection

Units	Counts
Participants	OG00016 OG00119 OG00214

Title

Denominators

Categories

Title	Measurements
	OG0002 OG00110 OG00210

Secondary

The Proportion of Subjects Who Are Responders (Defined as Having a 50% or Greater Improvement in Mean Worst Daily Leg Pain)

Denominator for % is the number of non-missing values for each treatment group at the visit of interest for the mITT population

Posted

Number

percentage of participants

Baseline to 14, 30, 60, 90, 120, 150, and 180 days

ID	Title	Description
OG000	0.9% Sodium Chloride for Injection	Placebo: Transforaminal Epidural Injection
OG001	12.5 mg SX600	Low Dose SX600: Transforaminal Epidural Injection
OG002	25.0 mg SX600	High Dose SX600: Transforaminal Epidural Injection

Units	Counts
Participants	OG000

Secondary

Change in Functional Outcomes as Measured by Patient's Global Impression of Change

Very much improved, or much improved from baseline

% based on number of non-missing values at the time of visit in mITT population

Posted

Number

percentage of participants

Baseline, 14, 30, 60, 90, 120, 150, and 180 days

ID	Title	Description
OG000	0.9% Sodium Chloride for Injection	Placebo: Transforaminal Epidural Injection
OG001	12.5 mg SX600	Low Dose SX600: Transforaminal Epidural Injection
OG002	25.0 mg SX600	High Dose SX600: Transforaminal Epidural Injection

Units	Counts
Participants	OG000

Secondary

Change in Functional Outcomes as Measured by the Oswestry Disability Index

0 - 20%: Minimal disability 21% - 40%: Moderate disability 41% - 60%: Severe disability 61% - 80%: Crippling back pain 81% - 100%: Bed-bound or exaggerating their symptoms

% based on number of non-missing values at the time of the visit for the mITT population

Posted

Mean

Standard Deviation

score on scale of 0% to 100%

Baseline, 14, 30, 60, 90, 120, 150, and 180 days

ID	Title	Description
OG000	0.9% Sodium Chloride for Injection	Placebo: Transforaminal Epidural Injection
OG001	12.5 mg SX600	Low Dose SX600: Transforaminal Epidural Injection
OG002	25.0 mg SX600	High Dose SX600: Transforaminal Epidural Injection

Units	Counts
Participants

Secondary

Change From Baseline in Short Form 36 Questionnaire (SF-36)

SF-36 is a self-administered, generic health status questionnaire consisting of 36 questions that measure 8 health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Each health concept has a range of possible total scores from 0 to 100. A high score defines a more favorable health state. The mean overall total score will be reported.

mITT population

Posted

Mean

Full Range

score on a scale

Baseline, 14, 30, 60, 90, 120, 150, and 180 days

ID	Title	Description
OG000	0.9% Sodium Chloride for Injection	Placebo: Transforaminal Epidural Injection
OG001	12.5 mg SX600	Low Dose SX600: Transforaminal Epidural Injection
OG002	25.0 mg SX600	High Dose SX600: Transforaminal Epidural Injection

Secondary

The Proportion of Subjects Who Are Responders (Defined as Having a 30% or Greater Improvement in Mean Worst Daily Leg Pain)

mITT population

Posted

Number

percentage of participants

Baseline to 14, 30, 60, 90, 120, 150, and 180 days

ID	Title	Description
OG000	0.9% Sodium Chloride for Injection	Placebo: Transforaminal Epidural Injection
OG001	12.5 mg SX600	Low Dose SX600: Transforaminal Epidural Injection
OG002	25.0 mg SX600	High Dose SX600: Transforaminal Epidural Injection

Units	Counts
Participants	OG000

Secondary

Proportion of Subjects Who Required Rescue Medication, as Reported in Patient Diary

ITT population

Posted

Count of Participants

Participants

Baseline through 180 days

ID	Title	Description
OG000	0.9% Sodium Chloride for Injection	Placebo: Transforaminal Epidural Injection
OG001	12.5 mg SX600	Low Dose SX600: Transforaminal Epidural Injection
OG002	25.0 mg SX600	High Dose SX600: Transforaminal Epidural Injection

Units	Counts
Participants	OG000

Secondary

Time to Loss of Response in the Subset of Patients Who Are Responders at Day 14 (50% or Greater Improvement in Mean Worst Daily Leg Pain)

Time to loss of response was analyzed in the subset of patients who had a 50% or greater improvement in mean WDLP score (i.e., 50% Responders) at Day 14 compared to Baseline.

Posted

Mean

Standard Error

days

Day 14 through 180 days

ID	Title	Description
OG000	0.9% Sodium Chloride for Injection	Placebo: Transforaminal Epidural Injection
OG001	12.5 mg SX600	Low Dose SX600: Transforaminal Epidural Injection
OG002	25.0 mg SX600	High Dose SX600: Transforaminal Epidural Injection

Units	Counts
Participants	OG000

Other Pre-specified

Proportion of Subjects Who Reduce Utilization of Supportive Health Services From Baseline, as Reported in Patient Diary

This endpoint was not included in the final SAP, thus this analysis was not conducted.

Posted

From baseline through 180 days

ID	Title	Description
OG000	0.9% Sodium Chloride for Injection	Placebo: Transforaminal Epidural Injection
OG001	12.5 mg SX600	Low Dose SX600: Transforaminal Epidural Injection
OG002	25.0 mg SX600	High Dose SX600: Transforaminal Epidural Injection

Units	Counts
Participants	OG000

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Alanine aminotransferase increased	Investigations	Non-systematic Assessment	EG0000 affected18 at risk EG0014 affected21 at risk EG0022 affected16 at risk
Blood cholesterol increased	Investigations	Non-systematic Assessment	EG0002 affected18 at risk EG0012 affected21 at risk EG0022 affected16 at risk
Blood creatine phosphokinase increased	Investigations	Non-systematic Assessment	EG0002 affected18 at risk EG0011 affected21 at risk EG0023 affected16 at risk
Blood lactate dehydrogenase increased	Investigations	Non-systematic Assessment	EG0002 affected18 at risk EG0011 affected21 at risk EG0022 affected16 at risk
Low density lipoprotein increased	Investigations	Non-systematic Assessment	EG0002 affected18 at risk EG0012 affected21 at risk EG0021 affected16 at risk
Aspartate aminotransferase increased	Investigations	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected21 at risk EG0022 affected16 at risk
Bilirubin conjugated increased	Investigations	Non-systematic Assessment	EG0002 affected18 at risk EG0010 affected21 at risk EG0020 affected16 at risk
Blood bilirubin increased	Investigations	Non-systematic Assessment	EG0002 affected18 at risk EG0010 affected21 at risk EG0020 affected16 at risk
Blood uric acid increased	Investigations	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected21 at risk EG0021 affected16 at risk
Gamma-glutamyltransferase increased	Investigations	Non-systematic Assessment	EG0000 affected18 at risk EG0012 affected21 at risk EG0020 affected16 at risk
White blood cell count increased	Investigations	Non-systematic Assessment	EG0000 affected18 at risk EG0011 affected21 at risk EG0021 affected16 at risk
Blood fibrinogen increased	Investigations	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected21 at risk EG0021 affected16 at risk
Blood glucose decreased	Investigations	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected21 at risk EG0020 affected16 at risk
Blood pressure increased	Investigations	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected21 at risk EG0021 affected16 at risk
Blood triglycerides increased	Investigations	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected21 at risk EG0020 affected16 at risk
Blood urine present	Investigations	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected21 at risk EG0021 affected16 at risk
Eosinophil count increased	Investigations	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected21 at risk EG0020 affected16 at risk
Glomerular filtration rate decreased	Investigations	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected21 at risk EG0020 affected16 at risk
Hepatic enzyme increased	Investigations	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected21 at risk EG0021 affected16 at risk
Neutrophil count decreased	Investigations	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected21 at risk EG0021 affected16 at risk
White blood cell count decreased	Investigations	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected21 at risk EG0021 affected16 at risk
Back pain	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0005 affected18 at risk EG0012 affected21 at risk EG0022 affected16 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected21 at risk EG0021 affected16 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 affected18 at risk EG0011 affected21 at risk EG0021 affected16 at risk
Muscle weakness	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected21 at risk EG0020 affected16 at risk
Neck pain	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected21 at risk EG0021 affected16 at risk
Hypoesthesia	Nervous system disorders	Non-systematic Assessment	EG0003 affected18 at risk EG0012 affected21 at risk EG0020 affected16 at risk
Sciatica	Nervous system disorders	Non-systematic Assessment	EG0002 affected18 at risk EG0010 affected21 at risk EG0021 affected16 at risk
Headache	Nervous system disorders	Non-systematic Assessment	EG0002 affected18 at risk EG0010 affected21 at risk EG0020 affected16 at risk
Areflexia	Nervous system disorders	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected21 at risk EG0021 affected16 at risk
Hyporeflexia	Nervous system disorders	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected21 at risk EG0021 affected16 at risk
Migraine	Nervous system disorders	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected21 at risk EG0021 affected16 at risk
Radiculopathy	Nervous system disorders	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected21 at risk EG0020 affected16 at risk
Sensory loss	Nervous system disorders	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected21 at risk EG0021 affected16 at risk
Upper respiratory tract infection	Infections and infestations	Non-systematic Assessment	EG0001 affected18 at risk EG0011 affected21 at risk EG0021 affected16 at risk
Urinary tract infection	Infections and infestations	Non-systematic Assessment	EG0000 affected18 at risk EG0011 affected21 at risk EG0022 affected16 at risk
COVID-19	Infections and infestations	Non-systematic Assessment	EG0002 affected18 at risk EG0010 affected21 at risk EG0020 affected16 at risk
Rhinitis	Infections and infestations	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected21 at risk EG0020 affected16 at risk
Pain	General disorders	Non-systematic Assessment	EG0005 affected18 at risk EG0010 affected21 at risk EG0021 affected16 at risk
Injection site pain	General disorders	Non-systematic Assessment	EG0002 affected18 at risk EG0011 affected21 at risk EG0020 affected16 at risk
Gait disturbance	General disorders	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected21 at risk EG0021 affected16 at risk
Malaise	General disorders	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected21 at risk EG0021 affected16 at risk
Anemia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0000 affected18 at risk EG0011 affected21 at risk EG0021 affected16 at risk
Leukopenia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected21 at risk EG0021 affected16 at risk
Neutropenia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected21 at risk EG0021 affected16 at risk
Increased tendency to bruise	Blood and lymphatic system disorders	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected21 at risk EG0020 affected16 at risk
Limb injury	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 affected18 at risk EG0011 affected21 at risk EG0020 affected16 at risk
Back injury	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected21 at risk EG0021 affected16 at risk
Rib fracture	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected21 at risk EG0021 affected16 at risk
Vaccination complication	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected21 at risk EG0020 affected16 at risk
Abdominal adhesions	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected21 at risk EG0020 affected16 at risk
Diarrhea	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected21 at risk EG0020 affected16 at risk
Nausea	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected21 at risk EG0021 affected16 at risk
Small intestinal obstruction	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected21 at risk EG0020 affected16 at risk
Anxiety	Psychiatric disorders	Non-systematic Assessment	EG0000 affected18 at risk EG0012 affected21 at risk EG0020 affected16 at risk
Abnormal dreams	Psychiatric disorders	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected21 at risk EG0020 affected16 at risk
Depression	Psychiatric disorders	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected21 at risk EG0021 affected16 at risk
Hypernatremia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected21 at risk EG0021 affected16 at risk
Iron deficiency	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected21 at risk EG0021 affected16 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected21 at risk EG0021 affected16 at risk
Erythema	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected21 at risk EG0021 affected16 at risk
Pruritis	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected21 at risk EG0020 affected16 at risk
Proteinuria	Renal and urinary disorders	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected21 at risk EG0021 affected16 at risk
Renal colic	Renal and urinary disorders	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected21 at risk EG0021 affected16 at risk
Menopausal symptoms	Reproductive system and breast disorders	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected21 at risk EG0021 affected16 at risk

ID	Term
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases
D020426	Sciatic Neuropathy
D020422	Mononeuropathies
D009437	Neuralgia
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D001416	Back Pain

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	0.9% Sodium Chloride for Injection	Placebo: Transforaminal Epidural Injection	18	3	18	15	18
EG001	12.5 mg SX600	Low Dose SX600: Transforaminal Epidural Injection	21	0	21	16	21
EG002	25.0 mg SX600	High Dose SX600: Transforaminal Epidural Injection	16	1	16	14	16