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Safety and Efficacy of Dextromethorphan and Quinidine in the Treatment of the Pain of Diabetic Neuropathy - Article


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General Topics A-Z

Quinidine

Cardioquin; Quinora

Clinical Trial: Safety and Efficacy of Dextromethorphan and Quinidine in the Treatment of the Pain of Diabetic Neuropathy

This study is currently recruiting patients.

Sponsored by: Avanir Pharmaceuticals
Information provided by: Avanir Pharmaceuticals

Purpose

The purpose of this study is to determine whether dextromethorphan (Neurodex) and quinidine are effective in the treatment of pain of diabetic neuropathy.
Condition Intervention Phase
Pain
Diabetic Neuropathies
  Drug: Neurodex
 Phase III

MedlinePlus related topics:  Diabetic Nerve Problems;   Pain

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title: A Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy of Dextromethorphan and Quinidine at Two Dose Levels in the Treatment of the Pain of Diabetic Neuropathy

Further Study Details: 
Primary Outcomes: Pain rating scale obtained from patient diaries
Secondary Outcomes: Additional diary rating scales and scores obtained from clinic visits
Expected Total Enrollment:  450

Study start: July 2005;  Expected completion: September 2006

Eligibility

Ages Eligible for Study:  18 Years   -   80 Years,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

  • Diagnosis of diabetes mellitus
  • Established diabetic therapy for at least 3 months
  • Lab-supported diagnosis of painful diabetic distal symmetric sensory/motor polyneuropathy
  • Pain the previous three months
  • Not pregnant

Exclusion Criteria:

  • Patient failed adequate trial of 3 or more medications or has required narcotics for pain
  • History of torsades de pointes
  • Sensitivity to quinidine or opiate drugs (codeine, etc)
  • Severe pain that could confound the assessment
  • Patient has had any amputations
  • Patient has participated in the past 30 days or is currently participating in another trial
  • Patient has previously received treatment with dextromethorphan and quinidine

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00113620


Alabama
      Medical Affiliated Research Center, Inc., Huntsville,  Alabama,  35801,  United States; Recruiting
Tanya Thompson  256-533-6603    jgm@marcresearch.com 
Timothy M Howard, MD,  Principal Investigator

      Radiant Research, Birmingham,  Alabama,  35209,  United States; Recruiting
Sharon Harrington  205-870-8803    danalevering@radiantresearch.com 
Robert L Pearlman, MD,  Principal Investigator

Arizona
      Pivotal Research Centers, Peoria,  Arizona,  85381,  United States; Recruiting
Diane Parker  623-815-9714 
Louis C Kirby, MD,  Principal Investigator

      Pivotal Research Centers, Mesa,  Arizona,  85210,  United States; Recruiting
Donna Bunton  480-615-3200 
Craig M McCarthy, MD,  Principal Investigator

Arkansas
      NEA Clinic, Jonesboro,  Arkansas,  72401,  United States; Recruiting
Todd Carr, LPN  501-221-5018 
Kevin Ganong, MD,  Principal Investigator

California
      PSMS Research, Palm Springs,  California,  92262,  United States; Recruiting
Glenna Knotts  760-416-3505    gknotts@pacificsleepmedicine.com 
Stuart Menn, MD,  Principal Investigator

      South Bay Clinical Research Inc., Inglewood,  California,  90301,  United States; Recruiting
Emilia Reorizo  310-419-4303 
Michael Robinson, MD,  Principal Investigator

      Diablo Clinical Research, Inc., Walnut Creek,  California,  94598,  United States; Recruiting
Lana Norman, CRC  925-930-7267  Ext. 247 
Richard L Weinstein, MD,  Principal Investigator

      Northern California Research Group, Carmichael,  California,  95628,  United States; Recruiting
Nav Nagra, RN, CRC  916-484-0500 
Douglas Young, MD,  Principal Investigator

Florida
      FPA Clinical Research, Kissimmee,  Florida,  34741,  United States; Recruiting
Jose Perez, MD  407-846-6625    fpaclinresearch@aol.com 
Christopher M Chappel, MD,  Principal Investigator

      Tampa Bay Medical Research, Clearwater,  Florida,  33761,  United States; Recruiting
Anna Tener  727-724-3361    tbmr1@gte.net 
Jerry Drucker, MD,  Principal Investigator

      The Center for Diabetes and Endocrine Care, Hollywood,  Florida,  33021,  United States; Recruiting
Simona Civica  954-963-7191  Ext. 234 
Sam S Lerman, MD,  Principal Investigator

      Renstar Medical Research, Ocala,  Florida,  34471,  United States; Recruiting
Debra Brown  352-629-5800    renstar@atlantic.net 
John Nardondrea, MD,  Principal Investigator

      University Clinical Research - DeLand, Deland,  Florida,  32720,  United States; Recruiting
Crystal Paligraf  386-740-0770 
Albert T Razetti, MD,  Principal Investigator

      Suncoast Neuroscience Associates, Inc., St. Petersburg,  Florida,  33701,  United States; Recruiting
Michele Richardson  727-824-7135 
Alberto B Vasquez, MD,  Principal Investigator

Hawaii
      East-West Medical Research Institute, Honolulu,  Hawaii,  96814,  United States; Recruiting
Tracy Kam  808-440-4413 
David Fitz-Patrick, MD,  Principal Investigator

Illinois
      Paryam and Kroll Healthcare, Arlington,  Illinois,  60004,  United States; Recruiting
Erin Tibo  773-774-3100    tiboe@pk-research.com 
Steven M Malkin, MD,  Principal Investigator

Indiana
      Medisphere Medical Research Center, LLC, Evansville,  Indiana,  47714,  United States; Recruiting
Mindy Swanker, LPN  812-471-4110    mswanker@medisphereresearch.com 
Steven K Elliott, MD,  Principal Investigator

Louisiana
      Dolby Research LLC, New Orleans,  Louisiana,  70128,  United States; Recruiting
Sunil Talwar  504-244-4405    talwars@dolby22.com 
Jamie Olivo, MD,  Principal Investigator

Maryland
      HealthCore, Inc., Elkton,  Maryland,  21921,  United States; Recruiting
John Schumacher  410-392-3010 
Julie Poludniak, MD,  Principal Investigator

Missouri
      Radiant Research - St. Louis, St. Louis,  Missouri,  63141,  United States; Recruiting
Christine Kottman  314-692-2100 
Candice Grasse  314-692-2100    candacegrasse@radiantresearch.com 
Anthony Margherita, MD,  Principal Investigator

Nebraska
      Creighton University, Omaha,  Nebraska,  68131,  United States; Recruiting
Greg Wigington  402-280-4319 
Marc Rendell, MD,  Principal Investigator

New Mexico
      Lovelace Scientific Resources, Albuquerque,  New Mexico,  87108,  United States; Recruiting
Rebecca Sandall  505-348-9398    dharbour@lrri.org 
Sharyl Magnuson, MD,  Principal Investigator

New York
      Weill Medical College of Cornell University - Peripheral Neuropathy Center, New York,  New York,  10022,  United States; Recruiting
Corinna Cassillo  212-888-8516 
Thomas H Brannagan, III, MD,  Principal Investigator

      DiGiovanna Family Care Center, Great Neck,  New York,  11021,  United States; Recruiting
Shara Brull  516-470-6905 
Michael J DiGiovanna, MD,  Principal Investigator

      The Medical Reserach Network, LLC, New York,  New York,  10024,  United States; Recruiting
Guadalupe E Zuniga  212-595-5012    MRN.NYC@verizon.net 
Michael D Katz, MD,  Principal Investigator

Ohio
      Radiant Research - Akron, Mogadore,  Ohio,  44260,  United States; Recruiting
Annette Pangle  330-628-6001    monicajuran@radiantresearch.com 
Dennis C McCluskey, MD,  Principal Investigator

      Radiant Research, Cincinnati,  Ohio,  45236,  United States; Recruiting
Ann Brewer  513-984-6887    nancycipollone@radiantresearch.com 
Michael J Noss, MD,  Principal Investigator

      DataPharm, Inc., Canfield,  Ohio,  44406,  United States; Recruiting
Renee Vitullo  330-533-3646 
Donald J Tamulonis, MD,  Principal Investigator

Oklahoma
      Hillcrest Medical Group, Tulsa,  Oklahoma,  74104,  United States; Recruiting
Barbara Converse  501-221-5018 
Steven Landgarten, MD,  Principal Investigator

Pennsylvania
      Knights Road Medical, Bensalem,  Pennsylvania,  19020,  United States; Recruiting
Carol Brown  215-638-8500 
Stevan A Smallow, MD,  Principal Investigator

Rhode Island
      Omega Medical Research, Warwick,  Rhode Island,  02886,  United States; Recruiting
Joy Greer, RN  401-739-9350    omrtrials@aol.com 
David L Fried, MD,  Principal Investigator

South Carolina
      Radiant Research - Greer, Greer,  South Carolina,  29651,  United States; Recruiting
Karen Hill  864-877-9239    karenhill@radiantreasearch.com 
William T Ellison, MD,  Principal Investigator

Texas
      Radiant Research, Dallas,  Texas,  75231,  United States; Recruiting
Susan Sargent  214-987-1616    susansargent@radiantresearch.com 
Carlos Arauz-Pacheco, MD,  Principal Investigator

      Juno Research, Houston,  Texas,  77099,  United States; Recruiting
Gilma Martinez  713-882-6857    junoresearch@yahoo.com 
Cecilia McKeown-Biagas, MD,  Principal Investigator

      SAM Clinical Research, San Antonio,  Texas,  782229,  United States; Recruiting
Caroline Cooney  210-614-4800    carolinek@samcrc.com 
Sam S Miller, MD,  Principal Investigator

      Diabetes & Glandular Disease Research Assoc., San Antonio,  Texas,  78229,  United States; Recruiting
Tatiana Powell  210-615-5565 
Sherwyn L Schwartz, MD,  Principal Investigator

Utah
      Radiant Research, Salt Lake City,  Utah,  84107,  United States; Recruiting
Kim Beaulieu  801-261-8930    kimbeaulieu@radiantresearch.com 
Spencer B Jones, MD,  Principal Investigator

Virginia
      Tidewater Integrated Medical Research, Virginia Beach,  Virginia,  23451,  United States; Recruiting
Jean Clarke, RN  757-233-9280 
Stephen W Kayota, MD,  Principal Investigator

      Hampton Roads Center for Clinical Research, Norfolk,  Virginia,  23502,  United States; Recruiting
Ashley Hall  757-461-3633 
Barry Lubin, MD,  Principal Investigator

Wisconsin
      University of Wisconsin Medical School, Madison,  Wisconsin,  53792,  United States; Recruiting
Judy VanKirk  608-265-0612    jvk@clinicaltrials.wisc.edu 
Miroslav Backonja, MD,  Principal Investigator

More Information

Study ID Numbers:  04-AVR-109
Record last reviewed:  June 2005
Last Updated:  June 30, 2005
Record first received:  June 9, 2005
ClinicalTrials.gov Identifier:  NCT00113620
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-05


Source: ClinicalTrials.gov
Cache Date: July 6, 2005


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Page Updated: October 3, 2005
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