NCT01350622

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2011

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2011

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 10, 2011

Completed
7 months until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

December 21, 2016

Status Verified

December 1, 2016

Enrollment Period

1 year

First QC Date

April 29, 2011

Last Update Submit

December 19, 2016

Conditions

PainAnkle Sprain

Keywords

pain management

Outcome Measures

Primary Outcomes (1)

  • Change in pain score

    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 Outcomes (1)

  • pain trajectory model

    nine months

Study Arms (2)

Pennsaid

EXPERIMENTAL

Active Pennsaid and oral placebo

Drug: PENNSAID

Oral Diclofenac

ACTIVE COMPARATOR

Oral diclofenac and placebo lotion (2.3% DMSO solution)

Drug: Diclofenac hydroxyethylpyrrolidine

Interventions

PENNSAIDDRUG

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.

Pennsaid
Diclofenac hydroxyethylpyrrolidineDRUG

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.

Oral Diclofenac

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Related Publications (11)

  • 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.

    PMID: 16086839BACKGROUND

  • 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.

    PMID: 21237721BACKGROUND

  • Moen MD. Topical diclofenac solution. Drugs. 2009;69(18):2621-32. doi: 10.2165/11202850-000000000-00000.

    PMID: 19943711BACKGROUND

  • 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.

    PMID: 18570BACKGROUND

  • 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.

    PMID: 20854305BACKGROUND

  • 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.

    PMID: 15477437BACKGROUND

  • 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.

    PMID: 15039693BACKGROUND

  • 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.

    PMID: 17306626BACKGROUND

  • 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.

    PMID: 16511925BACKGROUND

  • 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.

    PMID: 15468367BACKGROUND

  • 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.

    PMID: 9794502BACKGROUND

MeSH Terms

Conditions

PainAnkle InjuriesAgnosia

Interventions

Diclofenacdiclofenac hydroxyethylpyrrolidine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsLeg InjuriesWounds and InjuriesPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Richard Chapman, PhD

    University of Utah

    STUDY DIRECTOR

  • Virgil Davis, MD

    University of Utah

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2011

First Posted

May 10, 2011

Study Start

December 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

December 21, 2016

Record last verified: 2016-12

Locations

US(1)