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NCT00813813 · ClinicalTrials.gov registry record · Phase 1

Intradiscal rhGDF-5 Phase I/II Clinical Trial

A Phase 1 study, sponsored by DePuy Spine.

Completed
Registry status
Phase 1
Development phase
32
Enrollment target

NCT00813813: Completed Phase 1 study, sponsored by DePuy Spine.

NCT00813813 is a Phase 1 study that has completed, run by DePuy Spine. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00813813, a Phase 1 study, has completed, sponsored by DePuy Spine.

COMPLETED
Registry status
Phase 1
Development phase
32 participants
Enrollment target

Study Summary

Study to show the effectiveness and safety of a single injection of rhGDF5 into a degenerating single spinal disc in treating lumbar level degenerative disc disease

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

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2008-06
Est. Completion 2013-06
Phase Phase 1
DePuy Spine

5 total trials

What the finished NCT00813813 record still lists

NCT00813813 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).

The record links to 0 conditions, and to 1 intervention - of which Intradiscal rhGDF-5 is the first listed.

NCT00813813 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00813813 about?

NCT00813813 is a clinical study titled "Intradiscal rhGDF-5 Phase I/II Clinical Trial". Study to show the effectiveness and safety of a single injection of rhGDF5 into a degenerating single spinal disc in treating lumbar level degenerative disc disease

What is the current status of trial NCT00813813?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2008-06. Estimated completion is 2013-06.

What interventions are being tested in trial NCT00813813?

The interventions under investigation include: Intradiscal rhGDF-5 (DRUG).

Who is sponsoring clinical trial NCT00813813?

This trial is sponsored by DePuy Spine, which has 5 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00813813's enrollment target sits among peer trials

32 1296th of 2000 higher than 679 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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

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Source: ClinicalTrials.gov NCT00813813, the US trial registry maintained by the National Library of Medicine. NCT00813813 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.