Efficacy of PENNSAID® for Pain Management in the Emergency Department

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Covidien
Information provided by (Responsible Party):
Virgil Davis, University of Utah
ClinicalTrials.gov Identifier:
NCT01350622
First received: April 29, 2011
Last updated: April 11, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Pain
Ankle Sprain
Drug: PENNSAID
Drug: Diclofenac hydroxyethylpyrrolidine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of PENNSAID® for Pain Management in the Emergency Department

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Change in pain score [ Time Frame: Measure at 5 minute intervals for the duration of the ER visit ] [ Designated as safety issue: No ]
    Compare the pain relieving effect and speed of onset of PENNSAID to that of standard oral diclofenac.


Secondary Outcome Measures:
  • pain trajectory model [ Time Frame: nine months ] [ Designated as safety issue: No ]
    The secondary goal of the proposed work is to discover and model the onset and course of pain relief during the ED visit


Enrollment: 0
Study Start Date: December 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01350622

Locations
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
Virgil Davis
Covidien
Investigators
Study Director: Richard Chapman, PhD University of Utah
Principal Investigator: Virgil Davis, MD University of Utah
  More Information

Publications:

Responsible Party: Virgil Davis, M.D., University of Utah
ClinicalTrials.gov Identifier: NCT01350622     History of Changes
Other Study ID Numbers: 49065
Study First Received: April 29, 2011
Last Updated: April 11, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
pain management

Additional relevant MeSH terms:
Emergencies
Sprains and Strains
Ankle Injuries
Disease Attributes
Pathologic Processes
Wounds and Injuries
Leg Injuries
Diclofenac
Diclofenac hydroxyethylpyrrolidine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 29, 2014