Efficacy of PENNSAID® for Pain Management in the Emergency Department

December 19, 2016 updated by: University of Utah
The primary objective of this study is to compare the pain relieving effect and speed of onset of PENNSAID to that of standard oral diclofenac under double blind conditions using a growth curve approach to pain measurement. The investigators will test the hypothesis that PENNSAID will provide more rapid pain relief than oral diclofenac during the ED visit. The secondary goal of the proposed work is to discover and model the onset and course of pain relief during the emergency department (ED) visit.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion:

-We will include ED patients presenting with an acutely painful ankle sprain for which NSAIDs constitute standard of care pain management.

The following will be excluded:

  • Those with lacerations, bites, burns
  • any head trauma
  • pregnant
  • anyone with a pre-existing chronic pain condition
  • inflammatory intestinal disorders such as Crohn's disease or ulcerative colitis
  • anyone regularly using another NSAID or anti-coagulation medication
  • anyone who has experienced asthma after NSAID use
  • compromised cognitive abilities
  • a significant co-morbidity that will compromise participation
  • had joint replacements
  • known hypersensitivity to diclofenac or allergic responses to NSAIDs as a class
  • active stomach and/or duodenal ulceration or gastrointestinal bleeding
  • anyone admitted with severe active bleeding
  • recent heart surgery
  • severe liver or renal insufficiency
  • prisoner
  • mentally disabled patients
  • wards of the state
  • cognitive or decisional impairment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pennsaid
Active Pennsaid and oral placebo
Drug: PENNSAID
active treatment with PENNSAID and oral placebo. Subjects will apply 40 drops of Pennsaid to the affected ankle joint once, and will take a single placebo pill.
Active Comparator: Oral Diclofenac
Oral diclofenac and placebo lotion (2.3% DMSO solution)
Drug: Diclofenac hydroxyethylpyrrolidine
active treatment oral Diclofenac and PENNSAID placebo. Patients will take a single 50mg dose of oral diclofenac and will apply 40 drops of placebo lotion (2.3% DMSO) to the affected ankle once.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain score
Time Frame: Measure at 5 minute intervals for the duration of the ER visit
Compare the pain relieving effect and speed of onset of PENNSAID to that of standard oral diclofenac.
Measure at 5 minute intervals for the duration of the ER visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain trajectory model
Time Frame: nine months
The secondary goal of the proposed work is to discover and model the onset and course of pain relief during the ED visit
nine months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Collaborators

Medtronic - MITG

Investigators

  • Study Director: Richard Chapman, PhD, University of Utah
  • Principal Investigator: Virgil Davis, MD, University of Utah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

April 29, 2011

First Submitted That Met QC Criteria

May 9, 2011

First Posted (Estimate)

May 10, 2011

Study Record Updates

Last Update Posted (Estimate)

December 21, 2016

Last Update Submitted That Met QC Criteria

December 19, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 49065

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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