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Tablet vs. Liquid Suspension Ibuprofen in the Relief of Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01681667
Recruitment Status : Unknown
Verified March 2014 by Wayne Triner, Albany Medical College.
Recruitment status was:  Recruiting
First Posted : September 10, 2012
Last Update Posted : March 12, 2014
Information provided by (Responsible Party):
Wayne Triner, Albany Medical College

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.

Condition or disease Intervention/treatment Phase
Pharyngitis Drug: Ibuprofen Phase 4

Detailed Description:
Pain is a common emergency and urgent care complaint. Ibuprofen is known to be an effective treatment for many forms of pain. Sore throat has been established to be an acceptable model of analgesic effect, and ibuprofen has been found to offer relief in studies of sore throat. Several studies have demonstrated that ibuprofen in suspension is absorbed into the system more quickly and results in earlier maximum blood concentrations. To date, no study has evaluated onset to analgesia as reported by the patient for suspension versus tablet formation of ibuprofen in an emergency department population presenting with complaints of sore throat. This is a double blinded randomized placebo controlled trial to compare suspension versus tablet ibuprofen in an emergency department population presenting with sore throat. The purpose of this study is to assess whether ibuprofen in suspension form results in relief of pain more quickly than the tablet form of an equivalent dose of ibuprofen. We will also determine if there is an interval difference from time of analgesia administration to perception of analgesia that is clinically significant.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Tablet vs. Liquid Suspension Ibuprofen in the Relief of Pain
Study Start Date : September 2013
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sore Throat

Arm Intervention/treatment
Active Comparator: ibuprofen
liquid ibuprofen 400mg compared to tablet ibuprofen 400mg
Drug: Ibuprofen
ibuprofen liquid 400mg vs. ibuprofen tablet 400mg

Placebo Comparator: sugar pill or liquid

Primary Outcome Measures :
  1. Time of pain relief [ Time Frame: 1 hour ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   12 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01681667

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Contact: Nancy Robak, RN, MPH 518-262-3773

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United States, New York
Albany Medical Center Emergency Department Recruiting
Albany, New York, United States, 12204
Principal Investigator: Wayne Triner, DO, MPH         
Sponsors and Collaborators
Albany Medical College
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Principal Investigator: Wayne R Triner, DO, MPH Albany Medical College Department of Emergency Medicine
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Responsible Party: Wayne Triner, Professor and Research Director Dept.of Emergency Medicine, Albany Medical College Identifier: NCT01681667    
Other Study ID Numbers: 3003
First Posted: September 10, 2012    Key Record Dates
Last Update Posted: March 12, 2014
Last Verified: March 2014
Additional relevant MeSH terms:
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Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action