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NCT00485433 · ClinicalTrials.gov registry record · Phase 2

Dose-ranging Study for Postoperative Analgesia in Subjects Undergoing Primary Unilateral Inguinal Hernia Repair

A Phase 2 study, sponsored by Pacira Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
98
Enrollment target

NCT00485433: Completed Phase 2 study, sponsored by Pacira Pharmaceuticals.

NCT00485433 is a Phase 2 study that has completed, run by Pacira Pharmaceuticals. The registered enrollment target is 98 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00485433, a Phase 2 study, has completed, sponsored by Pacira Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
98 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate three dose levels of SKY0402 compared with 105 mg of bupivacaine HCl.

Primary Outcome

The subject's pain intensity was to be assessed with activity (NRS-A), after the subject had moved himself from a supine position in bed to a sitting up position at the edge of the bed. The subject was to respond to the following question: "On a scale of 0 to 10, where 0=no pain and 10=worst possible pain, how much pain did you have while sitting up?"

Interventions

  • DRUG Bupivacaine HCl
  • DRUG SKY0402

Trial Details

FieldValue
Enrollment Target 98 participants
Start Date 2007-06
Est. Completion 2008-08
Phase Phase 2
Pacira Pharmaceuticals

88 total trials

What the finished NCT00485433 record still lists

NCT00485433 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% lower).

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

NCT00485433 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00485433 about?

NCT00485433 is a clinical study titled "Dose-ranging Study for Postoperative Analgesia in Subjects Undergoing Primary Unilateral Inguinal Hernia Repair". The purpose of this study is to evaluate three dose levels of SKY0402 compared with 105 mg of bupivacaine HCl.

What is the current status of trial NCT00485433?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 98 participants. The study started on 2007-06. Estimated completion is 2008-08.

What interventions are being tested in trial NCT00485433?

The interventions under investigation include: Bupivacaine HCl (DRUG), SKY0402 (DRUG).

Who is sponsoring clinical trial NCT00485433?

This trial is sponsored by Pacira Pharmaceuticals, which has 88 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00485433's enrollment target sits among peer trials

98 743rd of 2000 higher than 1,255 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 NCT00485433, the US trial registry maintained by the National Library of Medicine. NCT00485433 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.