This is a phase IIb, prospective, multi-country, multicenter, randomized, double-blind, placebo-controlled, parallel group study to investigate the efficacy, safety and transformation of NP following single intradiscal injection of STA363 (lactic acid) into one or two IVDs compared to placebo for the treatment of discogenic low back pain. This study will be conducted in Russia, Spain and the Netherlands.
This is a phase IIb, prospective, multi-country, multicenter, randomized, double-blind, placebo-controlled, parallel group study to investigate the efficacy, safety and transformation of NP following single intradiscal injection of STA363 (lactic acid) into one or two IVDs compared to placebo for the treatment of discogenic low back pain. This study will be conducted in Russia, Spain and the Netherlands. The primary objective is to demonstrate superiority of STA363 over placebo in reducing low back pain as measured by the NRS. A total of 168 patients will be screened in the study with the aim to recruit 126 patients to be randomly allocated to one of the three treatment groups: Group 1 - 42 patients will receive STA363 containing 90 mg (60 mg/mL) lactic acid Group 2 - 42 patients will receive STA363 containing 180 mg (120 mg/mL) lactic acid Group 3 - 42 patients will receive placebo The investigational medical product (IMP) will be injected into the center of up to two IVDs. Patients with two discs appropriate for treatment will be treated at both affected levels by two separate injections. Each patient will have 5 visits to study site and 1 telephone call. The patient's total time in the study will be approximately 61 weeks (\~15 months) including an 8-week screening period. Each patient will perform a screening visit (Visit 1) maximum 60 days before planned treatment. Randomization and treatment will be performed at Visit 2 (Day 1) after confirmation of patient's eligibility for the study. The IMP will be administered, monitored by fluoroscopy or other available method of real-time x-ray imaging to ensure that an injection is correctly placed in the IVD nucleus and that no leakage occurs. Immediately after treatment the patients should remain supine for as long as possible (at least 1 hour). For safety reasons, patients will be allowed to leave the clinic not earlier than 2 hours after the last injection. After leaving the clinic, patients will be offered analgesics and/or other measures according to standard clinical practice. They will also be given advice on restricted physical activity during the first two weeks after injection. Patients should not drive or operate machinery for 12 hours following the treatment procedure. Patients will be followed up at 1 month (Visit 3/Day 30±7, visit to study site), 3 months (Visit 4/Day 90±7, telephone call), 6 months (Visit 5/Day 180±7, visit to study site) and 12 months (Visit 6/Day 360±7, visit to study site) after treatment. Follow-up MRI will be conducted as part of Visit 5 and Visit 6, to assess the transformation of the NP into connective tissue and other disc characteristics.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
110
STA363 (90 mg) will be injected into maximally two pain-generating degenerated intervertebral discs
STA363 (180 mg) will be injected into maximally two pain-generating degenerated intervertebral discs
Placebo will be injected into maximally two pain-generating degenerated intervertebral discs
Alrijne Ziekenhuis Leiderdorp
Leiderdorp, Netherlands
Rijnstate Hospital Anesthesiology and Pain
Velp, Netherlands
Pain intensity at 6 months on a Numerical rating scale
Change from baseline at Month 6 in mean pain intensity measured on a Numerical rating scale (minimum value: 0; maximum value: 10) for 7 consecutive days. Lower scores means a better outcome.
Time frame: 6 months
Pain intensity at Month 1, Month 3 and Month 12 on a Numerical rating scale
Change from baseline at Month 1, 3 and 12 in mean pain intensity measured on a Numerical rating scale (minimum value: 0; maximum value: 10) for 7 consecutive days. Lower scores means a better outcome.
Time frame: 1 month, 3 months and 12 months
Oswestry Disability Index
Change from baseline in Oswestry Disability Index score (minimal-maximal values: 0-100 where a lower number means better outcome) at Month 1, Month 3, Month 6 and Month 12. Lower scores means a better outcome.
Time frame: 1 month, 3 months, 6 months and 12 months
EuroQoL 5-dimension 5-level
Change from baseline in EuroQoL 5-dimension 5-level-index at Month 1, Month 3, Month 6 and Month 12. Higher scores means a better outcome.
Time frame: 1 month, 3 months, 6 months and 12 months
Nucleus pulposus transformation
Quantitative changes in nucleus pulposus (NP) water content (reflecting transformation of NP into connective tissue) at Month 6 and Month 12 (T2-weighted magnetic resonance imaging \[MRI\] and quantification of T2). Lower scores means a better outcome.
Time frame: 6 and 12 months
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