A Single Ascending Dose Study of Safety and Tolerability of STA363 Compared to Placebo in 15 Patients With Chronic Discogenic Low Back Pain

Low Back Pain Clinical Trial

Official title:

A Prospective, Randomised, Double-blinded, Placebo-controlled, Single Ascending Dose Study Investigating the Safety and Local Tolerability of STA363 Compared to Placebo in 15 Patients With Chronic Discogenic Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03055845
• Other study ID #: STA-01
• Secondary ID: 2015-004812-39
• Status: Completed
• Phase: Phase 1
• Start date: March 27, 2017
• Est. completion date: August 29, 2019

Study information

• Verified date: February 2020
• Source: Stayble Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A phase I, randomized, double-blinded, placebo-controlled, single ascending dose study to investigate the safety, local tolerability and transformation of nucleus pulposus following intradiscal injection of STA363 or placebo in patients with discogenic low back pain.

15 patients will participate in either of 3 dose groups, each comprising 5 patients:

• Group 1: STA363 dose 1 (3 patients) or placebo (2 patients)

• Group 2: STA363 dose 2 (3 patients) or placebo (2 patients)

• Group 3: STA363 dose 3 (3 patients) or placebo (2 patients)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 29, 2019
• Est. primary completion date: August 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• Signed informed consent prior to any study-related procedures

• Chronic discogenic low back pain present for more than 6 months prior to the screening visit

• 20 to 60 years of age at the screening visit

• Insufficient response to at least 6 months of non-operative treatment (analgesics and/or antiinflammatory medication, physiotherapy etc.)

• A single lumbar disc appropriate for treatment at L3/4 to L5/S1, based on clinical evaluation by the investigator

• Pfirrmann grade II-III

• Ability to understand the written and verbal information about the study

Exclusion Criteria:

• Treatment with any investigational product within 3 months prior to the screening visit

• More than one painful intervertebral disc

• A painful intervertebral disc above L3/4 level

• Current infection or prior history of spinal infection (e.g., discitis, septic arthritis, epidural abscess) or an active systemic infection

• Previous lumbar spine surgery

• Previous disc invasive treatment procedures at the affected level(s) (e.g., intradiscal electrothermal therapy, intradiscal radiofrequency thermocoagulation)

• Pfirrmann grade I, IV and V

• Evidence of prior lumbar vertebral body fracture or trauma

• Need for spinal decompression assessed by the investigator

• Presence of disc extrusion or sequestration

• Patients previously included in the study

• Patients suffering from psychosomatic pain in the opinion of the investigator

• Referred leg pain of compressive origin

• Known alcohol and/or drug abuse

• Severe intercurrent illness (e.g. rheumatic disease or chronic pain syndrome) or concomitant treatment (e.g. immunosuppressive drugs), which, in the opinion of the investigator, may put the patient at risk when participating in the study, or affect the patient's ability to take part in the study

• Clinically significant abnormalities in clinical chemistry or haematology parameters as assessed by the investigator

• Pregnant or lactating females or intention to become pregnant within the study period

• Known allergy to any of the components of the drug product or placebo

• Known opioid allergy or intolerance

• Patients requiring treatment with warfarin or other anticoagulant therapy

• Unwillingness to refrain from treatment with non-steroidal anti-inflammatory drugs (NSAIDs) within 5 days before the planned study treatment

• Body weight less than 50 kg

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Drug:
• STA363
STA363, containing 3 different doses of active ingredient, in a volume of 1.5 mL. Administered as intradiscal injection.
• Placebo
Matching placebo solution with identical appearance to the test product, used as reference treatment. Administered as intradiscal injection.

Locations

Country	Name	City	State
Sweden	Stockholm Spine Center, Löwenströmska Sjukhuset	Upplands Väsby

Sponsors (1)

Lead Sponsor	Collaborator
Stayble Therapeutics

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	VAS pain (leg and back)		1, 4 and 12 weeks after injection
Other	Oswestry disability index (ODI) score		12 weeks after injection
Primary	Local injection site reactions		Up to 4 weeks after injection
Primary	Frequency and severity of adverse events		Up to 12 weeks after injection
Primary	Changes in routine safety laboratory parameters		Up to 12 weeks after injection
Primary	Visual analogue scale (VAS) pain (injection site)		Up to 15 minutes after injection
Primary	Changes in vital signs		Up to 12 weeks after injection
Primary	Changes in electrocardiogram (ECG)		1 day after injection
Primary	Changes in physical examination findings		1 and 12 weeks after injection
Primary	Changes in body weight		12 weeks after injection
Secondary	Transformation of nucleus pulposus into connective tissue by magnetic resonance imaging (MRI)		12 weeks after injection
Secondary	Disc height by MRI		12 weeks after injection