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Study Investigating STA363 Compared to Placebo in Patients With Chronic Discogenic Low Back Pain

NCT04673461 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2025-12-10

No results posted yet for this study

Summary

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.

Conditions

  • Discogenic Pain

Interventions

DRUG

STA363 containing 90 mg (60 mg/mL) lactic acid

STA363 (90 mg) will be injected into maximally two pain-generating degenerated intervertebral discs

DRUG

STA363 containing 180 mg (120 mg/mL) lactic acid

STA363 (180 mg) will be injected into maximally two pain-generating degenerated intervertebral discs

DRUG

Placebo

Placebo will be injected into maximally two pain-generating degenerated intervertebral discs

Sponsors & Collaborators

  • Stayble Therapeutics

    lead INDUSTRY

Principal Investigators

  • Jan Willem Kallewaard, MD, PhD · Rijnstate Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-31
Primary Completion
2023-09-01
Completion
2023-10-31

Countries

  • Netherlands
  • Russia
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04673461 on ClinicalTrials.gov