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NCT01618708 · ClinicalTrials.gov registry record · NA

A Study of the Safety and Effectiveness of Synvisc-One® (Hylan G-F 20) in Patients With Primary Osteoarthritis of the Hip

A NA study, sponsored by Genzyme, a Sanofi Company.

Completed
Registry status
NA
Development phase
357
Enrollment target

NCT01618708: Completed NA study, sponsored by Genzyme, a Sanofi Company.

NCT01618708 is a NA study that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 357 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01618708, a NA study, has completed, sponsored by Genzyme, a Sanofi Company.

COMPLETED
Registry status
NA
Development phase
357 participants
Enrollment target

Study Summary

The primary objective of this study was to demonstrate any changes in assessments of pain for participants receiving Synvisc-One compared to control.

Primary Outcome

WOMAC Numerical Rating Scale (NRS) 3.1 questionnaire is a health status measure questionnaire of 24 questions comprising 3 subscales (pain, stiffness and physical function). WOMAC A1 (measure of pain during walking on a flat surface) was measured on 11-point (NRS) ranging from 0 (none) to 10 (extreme), where lower score represents lower pain and higher score represents higher pain.

Interventions

  • DEVICE Placebo
  • DEVICE Synvisc-One (hylan G-F 20)

Trial Details

FieldValue
Enrollment Target 357 participants
Start Date 2012-09
Est. Completion 2015-06
Phase NA
Genzyme, a Sanofi Company

196 total trials

What the finished NCT01618708 record still lists

NCT01618708 is an interventional study that assigns participants to a tested intervention. The registered 357 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 (75% lower).

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

NCT01618708 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01618708 about?

NCT01618708 is a clinical study titled "A Study of the Safety and Effectiveness of Synvisc-One® (Hylan G-F 20) in Patients With Primary Osteoarthritis of the Hip". The primary objective of this study was to demonstrate any changes in assessments of pain for participants receiving Synvisc-One compared to control.

What is the current status of trial NCT01618708?

This trial is currently completed. It is a NA study. The enrollment target is 357 participants. The study started on 2012-09. Estimated completion is 2015-06.

What interventions are being tested in trial NCT01618708?

The interventions under investigation include: Placebo (DEVICE), Synvisc-One (hylan G-F 20) (DEVICE).

Who is sponsoring clinical trial NCT01618708?

This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01618708's enrollment target sits among peer trials

357 289th of 2000 higher than 1,710 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 NCT01618708, the US trial registry maintained by the National Library of Medicine. NCT01618708 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.