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NCT05516992 · ClinicalTrials.gov registry record · Phase 3
Moderate - Severe Degenerative Disc Disease Evaluation of the Lumbar Spine
A Phase 3 study of Lumbar Degenerative Disc Disease, sponsored by Spine BioPharma.
- Active
- Registry status
- Phase 3
- Development phase
- 417
- Enrollment target
- 20
- Study locations
NCT05516992 is a Phase 3 study of Lumbar Degenerative Disc Disease that is active but no longer recruiting, run by Spine BioPharma. The registered enrollment target is 417 participants. The trial reports 20 study locations across 11 states.
The verdict
NCT05516992, a Phase 3 study of Lumbar Degenerative Disc Disease, is active but no longer recruiting, sponsored by Spine BioPharma.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 417 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of the study is to confirm the safety and effectiveness of SB-01 For Injection in adult patients with chronic low back pain and related disability due to Lumbar Degenerative Disc Disease. The primary effectiveness hypothesis is superiority of the investigational product relative to control in terms of the percentage of subjects improving in pain-related disability.
Conditions Studied
Interventions
- DRUG SB-01 For Injection
- DRUG Sham Needle
Study Locations (20)
Florida
- Science Connections, LLC - Doral
- Coastal Clinical Research - Jacksonville
- Conquest Research - Orlando
- Conquest Research - Orlando
- Pain Relief Centers - St. Petersburg
- Tampa Pain Relief Center - Tampa
- Florida Pain Relief Group - Tampa
- Conquest Research - Winter Park
California
- Neurovations Research - Napa
- Source Healthcare - Santa Monica
Ohio
- Meta Medical Research Institute - Cincinnati
- META Medical Research Institute - Dayton
Alabama
- Central Alabama Research - Birmingham
Arizona
- Evolve Clinical Research - Phoenix
Georgia
- Vista Clinical Research, LLC - Newnan
Idaho
- Injury Care Research - Boise
Indiana
- The Orthopaedic Research Foundation, Inc (OrthoIndy) - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 417 participants |
| Start Date | 2022-08-19 |
| Est. Completion | 2025-08-27 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05516992
The ClinicalTrials.gov registry entry for NCT05516992 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 417 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Spine BioPharma, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Lumbar Degenerative Disc Disease appearing as the primary indexed condition, and to 2 interventions - of which SB-01 For Injection is the first listed.
NCT05516992 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Florida, California, Ohio.
Frequently Asked Questions
What is clinical trial NCT05516992 about?
NCT05516992 is a clinical study titled "Moderate - Severe Degenerative Disc Disease Evaluation of the Lumbar Spine". The purpose of the study is to confirm the safety and effectiveness of SB-01 For Injection in adult patients with chronic low back pain and related disability due to Lumbar Degenerative Disc Disease. The primary effectiveness hypothesis is superiority of the investigational product relative to contr...
What is the current status of trial NCT05516992?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 417 participants. The study started on 2022-08-19. Estimated completion is 2025-08-27.
What conditions does trial NCT05516992 study?
This clinical trial studies the following conditions: Lumbar Degenerative Disc Disease.
What interventions are being tested in trial NCT05516992?
The interventions under investigation include: SB-01 For Injection (DRUG), Sham Needle (DRUG).
Who is sponsoring clinical trial NCT05516992?
This trial is sponsored by Spine BioPharma, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05516992 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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