Trials / Completed
CompletedNCT00470600
Efficacy and Safety Study of Caldolor (IV Ibuprofen) in Hospitalized Adult Orthopedic Patients
A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF IBUPROFEN INJECTION (IVIb) FOR TREATMENT OF PAIN IN POST-OPERATIVE ORTHOPEDIC ADULT PATIENTS
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 185 (actual)
- Sponsor
- Cumberland Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Caldolor | 800 milligrams intravenous |
| OTHER | Normal Saline | Placebo comparator |
Timeline
- Start date
- 2007-05-01
- Primary completion
- 2008-09-01
- Completion
- 2008-09-01
- First posted
- 2007-05-08
- Last updated
- 2015-08-21
- Results posted
- 2011-12-08
Locations
9 sites across 2 countries: United States, South Africa
Source: ClinicalTrials.gov record NCT00470600. Inclusion in this directory is not an endorsement.