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NCT01925261 · ClinicalTrials.gov registry record · Phase 2

A Study Evaluating the Safety and Efficacy of Intra-articular Injections of TPX-100 in Subjects With Mild to Moderate Patello-Femoral Osteoarthritis Involving Both Knees

A Phase 2 study of Knee Osteoarthritis, sponsored by OrthoTrophix.

Completed
Registry status
Phase 2
Development phase
120
Enrollment target
1
Study location

NCT01925261 is a Phase 2 study of Knee Osteoarthritis that has completed, run by OrthoTrophix. The registered enrollment target is 120 participants, below the 303-participant average among 101 other Knee Osteoarthritis trials with a reported enrollment target (60% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01925261, a Phase 2 study of Knee Osteoarthritis, has completed, sponsored by OrthoTrophix.

COMPLETED
Registry status
Phase 2
Development phase
120 participants
Enrollment target
1
Study location

Study Summary

This one-year study is designed to investigate the safety and efficacy of TPX-100, a 23-amino acid chondrogenic peptide, delivered by intra-articular injection, in regeneration of knee cartilage in subjects with bilateral osteoarthritis of the knee.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG TPX-100 50mg
  • DRUG TPX-100 100mg
  • DRUG TPX-100 200mg
  • DRUG TPX-100 20mg

Study Locations (1)

Washington

  • C3 Clinical Research Associates - Seattle

Trial Details

FieldValue
Enrollment Target 120 participants
Start Date 2014-01
Est. Completion 2016-09
Phase Phase 2

Sponsor

OrthoTrophix

3 total trials

What the Registry Record Tells You About NCT01925261

The ClinicalTrials.gov registry entry for NCT01925261 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 303-participant average among 101 other Knee Osteoarthritis trials with a reported enrollment target (60% lower). The listed sponsor is OrthoTrophix, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Knee Osteoarthritis appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.

NCT01925261 reports 1 study location spanning 1 distinct geographic area - top geographies include Washington.

Frequently Asked Questions

What is clinical trial NCT01925261 about?

NCT01925261 is a clinical study titled "A Study Evaluating the Safety and Efficacy of Intra-articular Injections of TPX-100 in Subjects With Mild to Moderate Patello-Femoral Osteoarthritis Involving Both Knees". This one-year study is designed to investigate the safety and efficacy of TPX-100, a 23-amino acid chondrogenic peptide, delivered by intra-articular injection, in regeneration of knee cartilage in subjects with bilateral osteoarthritis of the knee.

What is the current status of trial NCT01925261?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2014-01. Estimated completion is 2016-09.

What conditions does trial NCT01925261 study?

This clinical trial studies the following conditions: Knee Osteoarthritis.

What interventions are being tested in trial NCT01925261?

The interventions under investigation include: Placebo (DRUG), TPX-100 50mg (DRUG), TPX-100 100mg (DRUG), TPX-100 200mg (DRUG), TPX-100 20mg (DRUG).

Who is sponsoring clinical trial NCT01925261?

This trial is sponsored by OrthoTrophix, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01925261 being conducted?

This trial has 1 study location across Washington. 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

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