deltatrials
Completed PHASE1/PHASE2 INTERVENTIONAL 1-arm NCT01158924

A Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Effectiveness of Single Administration Intradiscal rhGDF-5 for the Treatment of Early Stage Lumbar Disc Degeneration

A Phase I/IIa, Multicenter, Open-label, Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Effectiveness of Single Administration Intradiscal rhGDF-5 for the Treatment of Early Stage Lumbar Disc Degeneration

Sponsor: DePuy Spine

Conditions Early Lumbar Disc Degeneration
Interventions Intradiscal rhGDF-5
Updated 5 times since 2017 Last updated: Jan 26, 2016 Started: Mar 31, 2010 Primary completion: Mar 31, 2014 Completion: Mar 31, 2014
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1/PHASE2 trial investigates Early Lumbar Disc Degeneration and is currently completed. DePuy Spine leads this study, which shows 5 recorded versions since 2010 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 23 months · monthly snapshotCompleted

Change History

5 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed PHASE1/PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1/PHASE2

    Phase: PHASE1_PHASE2 → PHASE1/PHASE2

  3. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE1_PHASE2

  4. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE1_PHASE2

  5. Jan 2017 — Jun 2018 [monthly]

    Completed PHASE1_PHASE2

    First recorded

Mar 2010

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • DePuy Spine
  • Janssen-Cilag Pty Ltd
Data source: DePuy Spine

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations