Efficacy of PENNSAID® for Pain Management in the Emergency Department
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|ClinicalTrials.gov Identifier: NCT01350622|
Recruitment Status : Withdrawn (Study never initiated)
First Posted : May 10, 2011
Last Update Posted : December 21, 2016
|Condition or disease||Intervention/treatment||Phase|
|Pain Ankle Sprain||Drug: PENNSAID Drug: Diclofenac hydroxyethylpyrrolidine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Efficacy of PENNSAID® for Pain Management in the Emergency Department|
|Study Start Date :||December 2011|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||December 2012|
Active Pennsaid and oral placebo
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.
- 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.
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT01350622
|United States, Utah|
|University of Utah|
|Salt Lake City, Utah, United States, 84132|
|Study Director:||Richard Chapman, PhD||University of Utah|
|Principal Investigator:||Virgil Davis, MD||University of Utah|