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NCT02412735 · ClinicalTrials.gov registry record · Phase 3
Placebo-controlled Study to Evaluate Rexlemestrocel-L Alone or Combined With Hyaluronic Acid in Participants With Chronic Low Back Pain
A Phase 3 study, sponsored by Mesoblast.
- Completed
- Registry status
- Phase 3
- Development phase
- 404
- Enrollment target
NCT02412735: Completed Phase 3 study, sponsored by Mesoblast.
NCT02412735 is a Phase 3 study that has completed, run by Mesoblast. The registered enrollment target is 404 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02412735, a Phase 3 study, has completed, sponsored by Mesoblast.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 404 participants
- Enrollment target
Study Summary
This is a prospective, multicenter, randomized, double-blind, placebo-controlled Phase 3 study designed to evaluate the safety and efficacy of Mesoblast's rexlemestrocel-L alone or combined with hyaluronic acid (HA) in participants with chronic low back pain (\> 6 months) associated with moderate radiographic degenerative changes of a disc.
Primary Outcome
Overall treatment success was determined based on number of responders who had composite response at both months 12 and 24 evaluated per specified criteria. A treatment responder with treatment success was defined as a participant who met the 3 criteria of a composite responder analysis as: 50% or greater reduction in the lower-back pain visual analogue scale (VAS) score; 15-point or greater reduction in the Oswestry Disability Index (ODI) score; and lack of post-treatment interventions at the t
Interventions
- DRUG Placebo
- DRUG Rexlemestrocel-L
- DRUG Rexlemestrocel-L + HA Mixture
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 404 participants |
| Start Date | 2015-03-06 |
| Est. Completion | 2021-06-15 |
| Phase | Phase 3 |
What the finished NCT02412735 record still lists
NCT02412735 is an interventional study that assigns participants to a tested intervention. The registered 404 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02412735 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02412735 about?
NCT02412735 is a clinical study titled "Placebo-controlled Study to Evaluate Rexlemestrocel-L Alone or Combined With Hyaluronic Acid in Participants With Chronic Low Back Pain". This is a prospective, multicenter, randomized, double-blind, placebo-controlled Phase 3 study designed to evaluate the safety and efficacy of Mesoblast's rexlemestrocel-L alone or combined with hyaluronic acid (HA) in participants with chronic low back pain (\> 6 months) associated with moderate ra...
What is the current status of trial NCT02412735?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 404 participants. The study started on 2015-03-06. Estimated completion is 2021-06-15.
What interventions are being tested in trial NCT02412735?
The interventions under investigation include: Placebo (DRUG), Rexlemestrocel-L (DRUG), Rexlemestrocel-L + HA Mixture (DRUG).
Who is sponsoring clinical trial NCT02412735?
This trial is sponsored by Mesoblast, which has 25 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02412735's enrollment target sits among peer trials
404 914th of 2000 higher than 1,084 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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