Tablet vs. Liquid Suspension Ibuprofen in the Relief of Pain
1 other identifier
interventional
100
1 country
1
Brief Summary
Ibuprofen (also known as Advil or Motrin) is a medication that is known to reduce pain. It is also known that ibuprofen levels in the blood rise higher and faster if the medication is taken in liquid suspension. This study will attempt to determine if ibuprofen suspended in a liquid works to relieve sore throat pain faster than pills of ibuprofen. It will also determine whether patients with sore throat prefer to take pill or liquid form of the medication.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Sep 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 6, 2012
CompletedFirst Posted
Study publicly available on registry
September 10, 2012
CompletedStudy Start
First participant enrolled
September 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedMarch 12, 2014
March 1, 2014
1.7 years
September 6, 2012
March 10, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Time of pain relief
Comparing liquid ibuprofen to tablet ibuprofen to determine which works faster to relieve sore throat pain. We will also determine whether patients with sore throat prefer to take pill or liquid form of medication.
1 hour
Study Arms (2)
ibuprofen
ACTIVE COMPARATORliquid ibuprofen 400mg compared to tablet ibuprofen 400mg
sugar pill or liquid
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Age greater than 12 years and less than 65 years
- Weight \> 40 kg
- a provider order for ibuprofen to address pharyngitis pain.
- Initial Numeric Pain Score \> 6
You may not qualify if:
- Known allergy or hypersensitivity to aspirin or NSAIDs
- Inability to swallow pills
- Inability to carry out informed consent in English
- Inability to complete a visual analog pain scale
- A concomitant order for another class of analgesic
- Use of analgesic within 8 hours
- Known 3rd trimester pregnancy
- Significant medical conditions where participation would pose an unnecessary barrier to ongoing care.
- Those taking opioid medications for more than 3 days
- Weight \< 40 kg
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Albany Medical Center Emergency Department
Albany, New York, 12204, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wayne R Triner, DO, MPH
Albany Medical College Department of Emergency Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor and Research Director Dept.of Emergency Medicine
Study Record Dates
First Submitted
September 6, 2012
First Posted
September 10, 2012
Study Start
September 1, 2013
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
March 12, 2014
Record last verified: 2014-03