Efficacy of PENNSAID® for Pain Management in the Emergency Department
NCT ID: NCT01350622
Last Updated: 2016-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2011-12-31
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Pennsaid
Active Pennsaid and oral placebo
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.
Oral Diclofenac
Oral diclofenac and placebo lotion (2.3% DMSO solution)
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.
Interventions
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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.
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 Criteria
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Inclusion Criteria
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
18 Years
ALL
No
Sponsors
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Medtronic - MITG
INDUSTRY
University of Utah
OTHER
Responsible Party
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Principal Investigators
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Richard Chapman, PhD
Role: STUDY_DIRECTOR
University of Utah
Virgil Davis, MD
Role: PRINCIPAL_INVESTIGATOR
University of Utah
Locations
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University of Utah
Salt Lake City, Utah, United States
Countries
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References
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Baer PA, Thomas LM, Shainhouse Z. Treatment of osteoarthritis of the knee with a topical diclofenac solution: a randomised controlled, 6-week trial [ISRCTN53366886]. BMC Musculoskelet Disord. 2005 Aug 8;6:44. doi: 10.1186/1471-2474-6-44.
Chapman CR, Donaldson GW, Davis JJ, Bradshaw DH. Improving individual measurement of postoperative pain: the pain trajectory. J Pain. 2011 Feb;12(2):257-62. doi: 10.1016/j.jpain.2010.08.005. Epub 2011 Jan 15.
Moen MD. Topical diclofenac solution. Drugs. 2009;69(18):2621-32. doi: 10.2165/11202850-000000000-00000.
Pritchard PH, Brindley DN. Studies on the ethanol-induced changes in glycerolipid synthesis in rats and their partial reversal by N-(2-benzoyloxyethyl)norfenfluramine (benfluorex). J Pharm Pharmacol. 1977 Jun;29(6):343-9. doi: 10.1111/j.2042-7158.1977.tb11332.x. No abstract available.
Galer BS. A comparative subjective assessment study of PENNSAID(R) and Voltaren Gel(R), two topical formulations of diclofenac sodium. Pain Pract. 2011 May-Jun;11(3):252-60. doi: 10.1111/j.1533-2500.2010.00420.x. Epub 2010 Sep 20.
Roth SH, Shainhouse JZ. Efficacy and safety of a topical diclofenac solution (pennsaid) in the treatment of primary osteoarthritis of the knee: a randomized, double-blind, vehicle-controlled clinical trial. Arch Intern Med. 2004 Oct 11;164(18):2017-23. doi: 10.1001/archinte.164.18.2017.
Rupp T, Delaney KA. Inadequate analgesia in emergency medicine. Ann Emerg Med. 2004 Apr;43(4):494-503. doi: 10.1016/j.annemergmed.2003.11.019.
Todd KH, Ducharme J, Choiniere M, Crandall CS, Fosnocht DE, Homel P, Tanabe P; PEMI Study Group. Pain in the emergency department: results of the pain and emergency medicine initiative (PEMI) multicenter study. J Pain. 2007 Jun;8(6):460-6. doi: 10.1016/j.jpain.2006.12.005. Epub 2007 Feb 15.
Towheed TE. Pennsaid therapy for osteoarthritis of the knee: a systematic review and metaanalysis of randomized controlled trials. J Rheumatol. 2006 Mar;33(3):567-73.
Tugwell PS, Wells GA, Shainhouse JZ. Equivalence study of a topical diclofenac solution (pennsaid) compared with oral diclofenac in symptomatic treatment of osteoarthritis of the knee: a randomized controlled trial. J Rheumatol. 2004 Oct;31(10):2002-12.
Hui X, Hewitt PG, Poblete N, Maibach HI, Shainhouse JZ, Wester RC. In vivo bioavailability and metabolism of topical diclofenac lotion in human volunteers. Pharm Res. 1998 Oct;15(10):1589-95. doi: 10.1023/a:1011911302005.
Other Identifiers
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49065
Identifier Type: -
Identifier Source: org_study_id