Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01124006 · ClinicalTrials.gov registry record · Phase 2
A Multicenter, Randomized, Double-blind, Placebo Controlled, Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Effectiveness of 2 Doses of Intradiscal rhGDF-5 (Single Administration) for the Treatment of Early Stage Lumbar Disc Degeneration
A Phase 2 study, sponsored by DePuy Spine.
- Completed
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
NCT01124006: Completed Phase 2 study, sponsored by DePuy Spine.
NCT01124006 is a Phase 2 study that has completed, run by DePuy Spine. The registered enrollment target is 24 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01124006, a Phase 2 study, has completed, sponsored by DePuy Spine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
Study Summary
Study to show the safety and tolerability of Intradiscal rhGDF-5 in subjects with early lumbar disc degeneration
Primary Outcome
Neurological Assessment for Motor Function and Reflexes/Sensory- Number of patients with Clinically Significant Abnormal results at 12 months. For Motor Function, Clinically Significant Abnormal results are determined by the surgeon investigator and are further classified by grade: 0= No Movement, 1= Flicker/trace of contraction, 2=Active movement when gravity removed, 3= Active movement against gravity, 4= Active Movement against gravity and resistance. For Reflexes/Sensory, Clinically Signif
Interventions
- DRUG Intradiscal rhGDF-5
- OTHER Water for injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2010-01 |
| Est. Completion | 2014-09 |
| Phase | Phase 2 |
What the finished NCT01124006 record still lists
NCT01124006 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 2 interventions - of which Intradiscal rhGDF-5 is the first listed.
NCT01124006 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01124006 about?
NCT01124006 is a clinical study titled "A Multicenter, Randomized, Double-blind, Placebo Controlled, Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Effectiveness of 2 Doses of Intradiscal rhGDF-5 (Single Administration) for the Treatment of Early Stage Lumbar Disc Degeneration". Study to show the safety and tolerability of Intradiscal rhGDF-5 in subjects with early lumbar disc degeneration
What is the current status of trial NCT01124006?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2010-01. Estimated completion is 2014-09.
What interventions are being tested in trial NCT01124006?
The interventions under investigation include: Intradiscal rhGDF-5 (DRUG), Water for injection (OTHER).
Who is sponsoring clinical trial NCT01124006?
This trial is sponsored by DePuy Spine, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01124006's enrollment target sits among peer trials
24 1756th of 2000 higher than 217 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02331979 · 24 participants · NA
Improving Bladder Function in SCI by Neuromodulation
- NCT03096197 · 24 participants · NA
Exoskeleton and Spinal Cord Stimulation for SCI
- NCT03223922 · 24 participants · NA
Neurocognitive Functioning With Genu-Sparing Whole Brain Radiation Therapy for Brain Metastases
- NCT03326921 · 24 participants · Phase 1
HA-1 T TCR T Cell Immunotherapy for the Treatment of Patients With Relapsed or Refractory Acute Leukemia After Donor Stem Cell Transplant
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia