Moderate - Severe Degenerative Disc Disease Evaluation of the Lumbar Spine
Public ClinicalTrials.gov record NCT05516992. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Multi-center, Randomized, Double-blind, Placebo-controlled Study, to Evaluate the Safety and Efficacy of SB-01 For Injection for the Treatment of Lumbar Degenerative Disc Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05516992
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 417 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 19, 2022 (Actual)
- Primary completion
- Mar 21, 2025 (Actual)
- Completion
- Aug 27, 2025 (Estimated)
- Last update posted
- Jun 10, 2025
2022 – 2025
United States locations
- U.S. sites
- 30
- U.S. states
- 15
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Central Alabama Research | Birmingham | Alabama | 35209 | — |
| Evolve Clinical Research | Phoenix | Arizona | 85013 | — |
| Neurovations Research | Napa | California | 94558 | — |
| Source Healthcare | Santa Monica | California | 90403 | — |
| Science Connections, LLC | Doral | Florida | 33178 | — |
| Coastal Clinical Research | Jacksonville | Florida | 32205 | — |
| Conquest Research | Orlando | Florida | 32804 | — |
| Conquest Research | Orlando | Florida | 32832 | — |
| Pain Relief Centers | St. Petersburg | Florida | 33709 | — |
| Tampa Pain Relief Center | Tampa | Florida | 33603 | — |
| Florida Pain Relief Group | Tampa | Florida | 33614 | — |
| Conquest Research | Winter Park | Florida | 32789 | — |
| Vista Clinical Research, LLC | Newnan | Georgia | 30265 | — |
| Injury Care Research | Boise | Idaho | 83713 | — |
| The Orthopaedic Research Foundation, Inc (OrthoIndy) | Indianapolis | Indiana | 46278 | — |
| Abay Neuroscience Center | Wichita | Kansas | 67226 | — |
| OrthoNebraska | Omaha | Nebraska | 68144 | — |
| Pioneer Clinical Research | New York | New York | 10016 | — |
| Meta Medical Research Institute | Cincinnati | Ohio | 45069 | — |
| META Medical Research Institute | Dayton | Ohio | 45432 | — |
| The Orthopedic Center | Tulsa | Oklahoma | 74104 | — |
| HD Research | Bellaire | Texas | 77401 | — |
| NeuroCare Partners | Houston | Texas | 77008 | — |
| South Texas Spinal Clinic | San Antonio | Texas | 78240 | — |
| Precision Spine Care | Tyler | Texas | 75701 | — |
| Tranquil Clinical Research | Webster | Texas | 77598 | — |
| Wasatch Clinical Research | Salt Lake City | Utah | 84107 | — |
| University of Utah | Salt Lake City | Utah | 84108 | — |
| Virginia iSpine Physicians | Richmond | Virginia | 23235 | — |
| Gershon Pain Specialists | Virginia Beach | Virginia | 23454 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05516992, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 10, 2025 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05516992 live on ClinicalTrials.gov.