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COMPLETED 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

NCT01925261 · View on ClinicalTrials.gov ↗

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

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01925261

The ClinicalTrials.gov registry entry for NCT01925261 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is OrthoTrophix, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01925261 reports 1 study location spanning 1 distinct geographic area — top geographies include Washington. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01925261?

This trial is sponsored by OrthoTrophix, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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