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NCT03838133 · ClinicalTrials.gov registry record · Phase 2

A Study to Evaluate Safety, PK, Efficacy of TLC590 for Postsurgical Pain Management Following Bunionectomy

A Phase 2 study, sponsored by Taiwan Liposome Company.

Completed
Registry status
Phase 2
Development phase
150
Enrollment target

NCT03838133: Completed Phase 2 study, sponsored by Taiwan Liposome Company.

NCT03838133 is a Phase 2 study that has completed, run by Taiwan Liposome Company. The registered enrollment target is 150 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (13% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03838133, a Phase 2 study, has completed, sponsored by Taiwan Liposome Company.

COMPLETED
Registry status
Phase 2
Development phase
150 participants
Enrollment target

Study Summary

This is a Phase 2, randomized, double-blind, 2-part comparator- and placebo-controlled study to evaluate the safety, PK, and efficacy of TLC590 via a single infiltrative local administration in adult subjects following bunionectomy.

Primary Outcome

AUC of numerical pain rating scale (NPRS-R) following bunionectomy surgery

Interventions

  • DRUG Bupivacaine
  • DRUG TLC590
  • DRUG Normal Saline
  • DRUG Naropin®

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2019-03-05
Est. Completion 2020-03-31
Phase Phase 2
Taiwan Liposome Company

7 total trials

What the finished NCT03838133 record still lists

NCT03838133 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (13% higher).

The record links to 0 conditions, and to 4 interventions - of which Bupivacaine is the first listed.

NCT03838133 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03838133 about?

NCT03838133 is a clinical study titled "A Study to Evaluate Safety, PK, Efficacy of TLC590 for Postsurgical Pain Management Following Bunionectomy". This is a Phase 2, randomized, double-blind, 2-part comparator- and placebo-controlled study to evaluate the safety, PK, and efficacy of TLC590 via a single infiltrative local administration in adult subjects following bunionectomy.

What is the current status of trial NCT03838133?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2019-03-05. Estimated completion is 2020-03-31.

What interventions are being tested in trial NCT03838133?

The interventions under investigation include: Bupivacaine (DRUG), TLC590 (DRUG), Normal Saline (DRUG), Naropin® (DRUG).

Who is sponsoring clinical trial NCT03838133?

This trial is sponsored by Taiwan Liposome Company, which has 7 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03838133's enrollment target sits among peer trials

150 455th of 2000 higher than 1,510 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT03838133, the US trial registry maintained by the National Library of Medicine. NCT03838133 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.