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NCT00225732 · ClinicalTrials.gov registry record · Phase 3

Trial of Caldolor for Treatment of Pain in Post-Operative Adult Patients

A Phase 3 study, sponsored by Cumberland Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
319
Enrollment target

NCT00225732: Completed Phase 3 study, sponsored by Cumberland Pharmaceuticals.

NCT00225732 is a Phase 3 study that has completed, run by Cumberland Pharmaceuticals. The registered enrollment target is 319 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00225732, a Phase 3 study, has completed, sponsored by Cumberland Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
319 participants
Enrollment target

Study Summary

The primary objective of this study of Caldolor (IV ibuprofen) administered to post-operative hospitalized adult patients every 6 hours for 48 hours is to determine the efficacy of Caldolor compared to placebo for the treatment of post-operative pain as measured by reduction in the requirement for the narcotic analgesic, morphine, post surgery

Primary Outcome

Change in the amount of morphine use (in milligrams) by subjects in each treatment group for a 24 hour period post-surgery

Interventions

  • DRUG Intravenous ibuprofen
  • OTHER Normal saline as placebo comparator

Trial Details

FieldValue
Enrollment Target 319 participants
Start Date 2005-01
Est. Completion 2008-01
Phase Phase 3
Cumberland Pharmaceuticals

43 total trials

What the finished NCT00225732 record still lists

NCT00225732 is an interventional study that assigns participants to a tested intervention. The registered 319 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% lower).

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

NCT00225732 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00225732 about?

NCT00225732 is a clinical study titled "Trial of Caldolor for Treatment of Pain in Post-Operative Adult Patients". The primary objective of this study of Caldolor (IV ibuprofen) administered to post-operative hospitalized adult patients every 6 hours for 48 hours is to determine the efficacy of Caldolor compared to placebo for the treatment of post-operative pain as measured by reduction in the requirement for t...

What is the current status of trial NCT00225732?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 319 participants. The study started on 2005-01. Estimated completion is 2008-01.

What interventions are being tested in trial NCT00225732?

The interventions under investigation include: Intravenous ibuprofen (DRUG), Normal saline as placebo comparator (OTHER).

Who is sponsoring clinical trial NCT00225732?

This trial is sponsored by Cumberland Pharmaceuticals, which has 43 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00225732's enrollment target sits among peer trials

319 1087th of 2000 higher than 914 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT00225732, the US trial registry maintained by the National Library of Medicine. NCT00225732 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.