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Sponsored by: |
Cumberland Pharmaceuticals |
Information provided by: | Cumberland Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00606489 |
The primary objective of this study of Amelior administered to hospitalized adult and pediatric burn patients is to determine the efficacy of Amelior on reducing fever when compared to placebo when administered every 6 hours for at least 24 hours.
Condition | Intervention | Phase |
Burns |
Drug: Amelior Drug: Placebo |
Phase III |
MedlinePlus related topics: | Burns Fever |
Drug Information available for: | Ibuprofen Dexibuprofen |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Ibuprofen Injection (IVIb) for Treatment of Fever and Pain in Burn Patients |
Estimated Enrollment: | 60 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Placebo Comparator |
Drug: Placebo
Placebo
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2: Experimental |
Drug: Amelior
800 mg of IVIb (patients > 12 years of age) or 10 mg/kg (patients < 12 years; maximum of 400 mg) q 6 hrs
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Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |||||
Orlando Regional Medical Center | Recruiting | ||||
Orlando, Florida, United States | |||||
Contact: Karen Safcsak, RN, BSN 321-841-8596 Toby.Safcsak@orhs.org | |||||
Principal Investigator: John T Promes, M.D. | |||||
United States, North Carolina | |||||
Wake Forest University Health Sciences | Recruiting | ||||
Winston-Salem, North Carolina, United States, 27157 | |||||
Contact: Kim East, TN 336-716-4155 kieast@wfubmc.edu | |||||
Principal Investigator: Peter Morris, M.D. | |||||
India | |||||
Surya Hospitals Pvt. Ltd | Recruiting | ||||
Pune, India, 411 011 | |||||
Contact: Naresh Jain, M.D. 020-24450050 | |||||
Contact: Sudhakar R Madhukar, M.D. 99220-63514 | |||||
Principal Investigator: Sudhakar R Madhukar, M.D. | |||||
Principal Investigator: Jaisingh K Shinde, M.D. | |||||
India, Kothi | |||||
Naik's Hospital | Recruiting | ||||
Baroda, Kothi, India, 390001 | |||||
Contact: Ankita Shah, M.D. 91-982434788 | |||||
Principal Investigator: Himanshu Naik, M.D. | |||||
Principal Investigator: Vibha Naik, M.D. | |||||
India, Sion | |||||
Lokmanya Tilak Municipal Medical College | Not yet recruiting | ||||
Mumbai, Sion, India, 400022 | |||||
Contact: Madhuri Gore, M.D. 022-24076381 | |||||
Principal Investigator: Madhuri Gore, M.D. |
Cumberland Pharmaceuticals |
Responsible Party: | Cumberland Pharmaceuticals Inc. ( Amy Rock, Ph.D., Senior Manager, Regulatory Affairs ) |
Study ID Numbers: | CPI-CL-010 |
First Received: | January 22, 2008 |
Last Updated: | September 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00606489 |
Health Authority: | United States: Food and Drug Administration |
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