CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 185 enrolled
Drug / intervention
Caldolor +1 moredrug
Likely dose
Caldolor 800 milligramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00470600
NCT00470600Phase 3Completed
CompareCT.gov

A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF IBUPROFEN INJECTION (IVIb) FOR TREATMENT OF PAIN IN POST-OPERATIVE ORTHOPEDIC ADULT PATIENTS

Cumberland Pharmaceuticals·interventional·Posted May 8, 2007·Updated Aug 21, 2015

In Brief

A Phase 3 clinical trial evaluating Caldolor and Normal Saline for Pain. Completed, enrolled 185 participants across 9 sites in 2 countries.

Detailed Summary

The primary objective of this study of Caldolor (IV ibuprofen) administered to post-operative hospitalized adult orthopedic patients every 6 hours for at least 24 hours is to determine the efficacy of Caldolor (IV ibuprofen) compared to placebo for the treatment of post-operative pain by patients self-assessment of pain.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesSouth Africa, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 8, 2007
Enrollment StartMay 1, 2007
Primary CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 19.2 years ago

Interventions

Caldolordrug

800 milligrams intravenous

Normal Salineother

Placebo comparator