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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

NCT03055845 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2020-02-18

No results posted yet for this study

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)

Conditions

  • Low Back Pain

Interventions

DRUG

STA363

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Stayble Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-27
Primary Completion
2019-08-29
Completion
2019-08-29

Countries

  • Sweden

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 NCT03055845 on ClinicalTrials.gov