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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03055845
Recruitment Status : Completed
First Posted : February 16, 2017
Last Update Posted : February 18, 2020
Sponsor:
Information provided by (Responsible Party):
Stayble Therapeutics

Brief 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)

Condition or disease Intervention/treatment Phase
Low Back Pain Drug: STA363 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Following treatment of 2 patients in each dose group (injections with active drug and placebo, respectively), safety data will be reviewed. If no safety or tolerability concerns are identified, the next 3 patients in each dose group will be treated (active treatment or placebo [2:1]).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : March 27, 2017
Actual Primary Completion Date : August 29, 2019
Actual Study Completion Date : August 29, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: STA363 dose 1 Drug: STA363
STA363, containing 3 different doses of active ingredient, in a volume of 1.5 mL. Administered as intradiscal injection.

Experimental: STA363 dose 2 Drug: STA363
STA363, containing 3 different doses of active ingredient, in a volume of 1.5 mL. Administered as intradiscal injection.

Experimental: STA363 dose 3 Drug: STA363
STA363, containing 3 different doses of active ingredient, in a volume of 1.5 mL. Administered as intradiscal injection.

Placebo Comparator: Placebo Drug: Placebo
Matching placebo solution with identical appearance to the test product, used as reference treatment. Administered as intradiscal injection.




Primary Outcome Measures :
  1. Local injection site reactions [ Time Frame: Up to 4 weeks after injection ]
  2. Frequency and severity of adverse events [ Time Frame: Up to 12 weeks after injection ]
  3. Changes in routine safety laboratory parameters [ Time Frame: Up to 12 weeks after injection ]
  4. Visual analogue scale (VAS) pain (injection site) [ Time Frame: Up to 15 minutes after injection ]
  5. Changes in vital signs [ Time Frame: Up to 12 weeks after injection ]
  6. Changes in electrocardiogram (ECG) [ Time Frame: 1 day after injection ]
  7. Changes in physical examination findings [ Time Frame: 1 and 12 weeks after injection ]
  8. Changes in body weight [ Time Frame: 12 weeks after injection ]

Secondary Outcome Measures :
  1. Transformation of nucleus pulposus into connective tissue by magnetic resonance imaging (MRI) [ Time Frame: 12 weeks after injection ]
  2. Disc height by MRI [ Time Frame: 12 weeks after injection ]

Other Outcome Measures:
  1. VAS pain (leg and back) [ Time Frame: 1, 4 and 12 weeks after injection ]
  2. Oswestry disability index (ODI) score [ Time Frame: 12 weeks after injection ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03055845


Locations
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Sweden
Stockholm Spine Center, Löwenströmska Sjukhuset
Upplands Väsby, Sweden, 19489
Sponsors and Collaborators
Stayble Therapeutics
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Responsible Party: Stayble Therapeutics
ClinicalTrials.gov Identifier: NCT03055845    
Other Study ID Numbers: STA-01
2015-004812-39 ( EudraCT Number )
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: February 18, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations