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NCT02951026 · ClinicalTrials.gov registry record

An Observational Study Evaluating the Safety, Tolerability, and Efficacy of Treatment of SM04690 or Placebo Previously Injected in the Target Knee Joint of Subjects With Moderately to Severely Symptomatic Osteoarthritis

A clinical trial, sponsored by Biosplice Therapeutics.

Completed
Registry status
703
Enrollment target

NCT02951026: Completed study, sponsored by Biosplice Therapeutics.

NCT02951026 is a clinical trial that has completed, run by Biosplice Therapeutics. The registered enrollment target is 703 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02951026 has completed, sponsored by Biosplice Therapeutics.

COMPLETED
Registry status
703 participants
Enrollment target

Study Summary

This long-term extension study is designed to monitor the long-term safety, tolerability, and efficacy of treatment of SM04690 or placebo previously injected in the target knee joints of subjects with moderately to severely symptomatic osteoarthritis (OA) from a Samumed-sponsored SM04690-OA phase 2 or phase 3 study. No additional SM04690 or placebo therapy will be administered in this study.

Primary Outcome

Compare the incidence rate of SAEs occurring in the (previously injected) SM04690 treatment arms to the (previously injected) placebo treatment arm by Month 60

Interventions

  • OTHER Not applicable (no therapy is administered as part of this study)

Trial Details

FieldValue
Enrollment Target 703 participants
Start Date 2016-09-19
Est. Completion 2019-10-31
Biosplice Therapeutics

20 total trials

What the finished NCT02951026 record still lists

NCT02951026 is an observational study that tracks outcomes without assigning an intervention. The registered 703 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 1 intervention - of which Not applicable (no therapy is administered as part of this study) is the first listed.

NCT02951026 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02951026 about?

NCT02951026 is a clinical study titled "An Observational Study Evaluating the Safety, Tolerability, and Efficacy of Treatment of SM04690 or Placebo Previously Injected in the Target Knee Joint of Subjects With Moderately to Severely Symptomatic Osteoarthritis". This long-term extension study is designed to monitor the long-term safety, tolerability, and efficacy of treatment of SM04690 or placebo previously injected in the target knee joints of subjects with moderately to severely symptomatic osteoarthritis (OA) from a Samumed-sponsored SM04690-OA phase 2 ...

What is the current status of trial NCT02951026?

This trial is currently completed. The enrollment target is 703 participants. The study started on 2016-09-19. Estimated completion is 2019-10-31.

What interventions are being tested in trial NCT02951026?

The interventions under investigation include: Not applicable (no therapy is administered as part of this study) (OTHER).

Who is sponsoring clinical trial NCT02951026?

This trial is sponsored by Biosplice Therapeutics, which has 20 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT02951026, the US trial registry maintained by the National Library of Medicine. NCT02951026 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.