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NCT03591146 · ClinicalTrials.gov registry record · Phase 1

Phase I/II Dose-escalation Study to Evaluate Safety, PK and Efficacy of TLC590 for Postsurgical Pain Management

A Phase 1 study, sponsored by Taiwan Liposome Company.

Completed
Registry status
Phase 1
Development phase
65
Enrollment target

NCT03591146: Completed Phase 1 study, sponsored by Taiwan Liposome Company.

NCT03591146 is a Phase 1 study that has completed, run by Taiwan Liposome Company. The registered enrollment target is 65 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03591146, a Phase 1 study, has completed, sponsored by Taiwan Liposome Company.

COMPLETED
Registry status
Phase 1
Development phase
65 participants
Enrollment target

Study Summary

Phase I/II, randomized, double-blind, comparator-controlled, dose-escalation study to assess the safety, PK, and efficacy of single postsurgical application of TLC590 compared with Naropin®

Primary Outcome

Event of serious adverse event (SAE) and treatment-related severe adverse event (TRAE)

Interventions

  • DRUG TLC590
  • DRUG Naropin

Trial Details

FieldValue
Enrollment Target 65 participants
Start Date 2018-07-31
Est. Completion 2019-01-14
Phase Phase 1
Taiwan Liposome Company

7 total trials

What the finished NCT03591146 record still lists

NCT03591146 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.

The record links to 0 conditions, and to 2 interventions - of which TLC590 is the first listed.

NCT03591146 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03591146 about?

NCT03591146 is a clinical study titled "Phase I/II Dose-escalation Study to Evaluate Safety, PK and Efficacy of TLC590 for Postsurgical Pain Management". Phase I/II, randomized, double-blind, comparator-controlled, dose-escalation study to assess the safety, PK, and efficacy of single postsurgical application of TLC590 compared with Naropin®

What is the current status of trial NCT03591146?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 65 participants. The study started on 2018-07-31. Estimated completion is 2019-01-14.

What interventions are being tested in trial NCT03591146?

The interventions under investigation include: TLC590 (DRUG), Naropin (DRUG).

Who is sponsoring clinical trial NCT03591146?

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 NCT03591146's enrollment target sits among peer trials

65 798th of 2000 higher than 1,193 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT03591146, the US trial registry maintained by the National Library of Medicine. NCT03591146 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.