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NCT01934218 · ClinicalTrials.gov registry record · NA

Gel-One Treatment in Knee Osteoarthritis

A NA study, sponsored by Seikagaku Corporation.

Completed
Registry status
NA
Development phase
814
Enrollment target

NCT01934218: Completed NA study, sponsored by Seikagaku Corporation.

NCT01934218 is a NA study that has completed, run by Seikagaku Corporation. The registered enrollment target is 814 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01934218, a NA study, has completed, sponsored by Seikagaku Corporation.

COMPLETED
Registry status
NA
Development phase
814 participants
Enrollment target

Study Summary

The purpose of this study is to determine whether Gel-One demonstrates a superior effectiveness in osteoarthritis (OA) knee pain compared with phosphate buffered saline (PBS) injections.

Primary Outcome

Observed VAS of 100 mm; 0 mm meaning no pain; 100 mm meaning extreme pain following 50-foot walk test. Change in score from baseline through week 26 was estimated using a longitudinal model.

Interventions

  • DEVICE Gel-One
  • DEVICE PBS

Trial Details

FieldValue
Enrollment Target 814 participants
Start Date 2013-08
Est. Completion 2016-03
Phase NA
Seikagaku Corporation

12 total trials

What the finished NCT01934218 record still lists

NCT01934218 is an interventional study that assigns participants to a tested intervention. The registered 814 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (42% lower).

The record links to 0 conditions, and to 2 interventions - of which Gel-One is the first listed.

NCT01934218 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01934218 about?

NCT01934218 is a clinical study titled "Gel-One Treatment in Knee Osteoarthritis". The purpose of this study is to determine whether Gel-One demonstrates a superior effectiveness in osteoarthritis (OA) knee pain compared with phosphate buffered saline (PBS) injections.

What is the current status of trial NCT01934218?

This trial is currently completed. It is a NA study. The enrollment target is 814 participants. The study started on 2013-08. Estimated completion is 2016-03.

What interventions are being tested in trial NCT01934218?

The interventions under investigation include: Gel-One (DEVICE), PBS (DEVICE).

Who is sponsoring clinical trial NCT01934218?

This trial is sponsored by Seikagaku Corporation, which has 12 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01934218's enrollment target sits among peer trials

814 134th of 2000 higher than 1,867 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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 NCT01934218, the US trial registry maintained by the National Library of Medicine. NCT01934218 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.