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NCT04636229 · ClinicalTrials.gov registry record · Phase 3

Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee

A Phase 3 study of Knee Osteoarthritis, sponsored by Organogenesis.

Completed
Registry status
Phase 3
Development phase
516
Enrollment target
20
Study locations

NCT04636229 is a Phase 3 study of Knee Osteoarthritis that has completed, run by Organogenesis. The registered enrollment target is 516 participants, above the 299-participant average among 101 other Knee Osteoarthritis trials with a reported enrollment target (73% higher). The trial reports 20 study locations across 8 states.

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The verdict

NCT04636229, a Phase 3 study of Knee Osteoarthritis, has completed, sponsored by Organogenesis.

COMPLETED
Registry status
Phase 3
Development phase
516 participants
Enrollment target
20
Study locations

Study Summary

This study is being conducted to evaluate the efficacy and safety of ASA compared to placebo in the management of osteoarthritis (OA) symptoms of the knee.

Conditions Studied

Interventions

  • DRUG Placebo
  • BIOLOGICAL Amniotic Suspension Allograft

Study Locations (20)

California

  • Tri West Research Associates - El Cajon
  • Horizon Clinical Research Center - La Mesa
  • Actca, A Member of the Allliance Inc. - Los Angeles
  • University of California at Los Angeles - Los Angeles
  • Stanford Medicine - Redwood City
  • University of California at Davis - Sacramento

Alabama

  • Central Research Associates - Birmingham
  • Alabama Clinical Therapeutics - Birmingham
  • AMR Mobile - Mobile

Arizona

  • Arizona Arthritis & Rheumatology Research - Glendale
  • Fiel Family & Sports Medicine/ CCT Research - Tempe
  • Arizona Arthritis & Rheumatology Research - Tucson

Illinois

  • Chicago Clinical Research Institute Inc - Chicago
  • Rush University Medical Center - Chicago
  • Affinity Health - Oak Brook

Florida

  • AARDS Research, Inc. - Aventura
  • Gulfcoast Research Institute - Sarasota

Georgia

  • Pinnacle Trials, Inc. - Stockbridge

Idaho

  • Injury Care Research - Boise

Maryland

  • Sinai Hospital of Baltimore - Baltimore

Trial Details

FieldValue
Enrollment Target 516 participants
Start Date 2020-12-14
Est. Completion 2025-08-19
Phase Phase 3

Sponsor

Organogenesis

20 total trials

What the Registry Record Tells You About NCT04636229

The ClinicalTrials.gov registry entry for NCT04636229 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 516 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 299-participant average among 101 other Knee Osteoarthritis trials with a reported enrollment target (73% higher). The listed sponsor is Organogenesis, which has 20 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Knee Osteoarthritis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT04636229 reports 20 study locations spanning 8 distinct geographic areas - top geographies include California, Alabama, Arizona.

Frequently Asked Questions

What is clinical trial NCT04636229 about?

NCT04636229 is a clinical study titled "Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee". This study is being conducted to evaluate the efficacy and safety of ASA compared to placebo in the management of osteoarthritis (OA) symptoms of the knee.

What is the current status of trial NCT04636229?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 516 participants. The study started on 2020-12-14. Estimated completion is 2025-08-19.

What conditions does trial NCT04636229 study?

This clinical trial studies the following conditions: Knee Osteoarthritis.

What interventions are being tested in trial NCT04636229?

The interventions under investigation include: Placebo (DRUG), Amniotic Suspension Allograft (BIOLOGICAL).

Who is sponsoring clinical trial NCT04636229?

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

Where is trial NCT04636229 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.