ClinicalTrials.gov
skipnavHome|Search|Browse|Resources|Help|What's New|About

Efficacy and Tolerability of ELMIRON

This study is currently recruiting patients.

Sponsored by: ALZA
Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
Information provided by: Johnson & Johnson Pharmaceutical Research and Development, L.L.C.

Purpose

The purpose of this research study is to test two doses of a drug called ELMIRON (pentosan polysulfate sodium). ELMIRON has been approved by the U.S. FDA for the relief of bladder pain or discomfort associated with interstitial cystitis (IC). You may not be on other medications that could affect your IC symptoms such as antihistamines, antidepressants, anticholingergics, or antispasmodics.

Condition Treatment or Intervention Phase
Interstitial Cystitis
  Drug: ELMIRON
 Drug: Placebo
 Phase III

MedlinePlus related topics:  Interstitial Cystitis

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

Official Title: Multi-center, Randomized, Double-blind, PBO-controlled Parallel Evaluation of the Efficacy and Tolerability of ELMIRON

Further Study Details: 

Primary Outcomes: Proportion of responders based on the reduction in the ICSI

Study start: August 2003;  Expected completion: December 2006
Last follow-up: July 2006;  Data entry closure: September 2006

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

Exclusion Criteria:


Location and Contact Information


Alabama
      University of Alabama, Birmingham,  Alabama,  35294,  United States; Recruiting
Wilma Childs-Irwin  205-975-9448 
Keith Lloyd,  Principal Investigator

      Millenium Therapeutic and Research, Birmingham,  Alabama,  35205,  United States; Recruiting
Linda Crumbley  205-930-8442 
Simon Mirelman,  Principal Investigator

      Urology Center of Alabama, PC, Homewood,  Alabama,  35209,  United States; Recruiting
Judy McMillian  205-445-0125 
Walter G Pittman,  Principal Investigator

Alaska
      Alaska Clinical Research, Anchorage,  Alaska,  99508,  United States; Recruiting
Krista Ramgitsch  907-276-1455 
Kevin Tomera,  Principal Investigator

California
      San Bernardino Urological Association, San Bernardino,  California,  92404,  United States; Recruiting
Charity Hernandez  909-882-2973 
Franklin Chu,  Principal Investigator
Daniel Lama,  Principal Investigator

      Scripps Clinic and Research Institute, LaJolla,  California,  92037,  United States; Recruiting
Deborah Coye  858-554-9040 
Bruce S Kahn,  Principal Investigator

      San Diego Uro-Research, San Diego,  California,  92101,  United States; Recruiting
Patti Sanchez-Emery  619-236-0045 
Marianne Rochester,  Principal Investigator

      Western Clinical Research Inc, Torrance,  California,  90505,  United States; Recruiting
Shadi Javadifar  310-378-5003  Ext. 142 
Norman Zinner,  Principal Investigator

Colorado
      Urogynecology Associates of Colorado, Denver,  Colorado,  80220,  United States; Recruiting
Sally Jobe  303-322-0500 
Oscar Aguirre,  Principal Investigator

      Longmont Medical Research Network, Longmont,  Colorado,  80501,  United States; Recruiting
Julia Natvig  303-776-8718 
Sean Manion,  Principal Investigator

Florida
      Urology Consultants, Longwood,  Florida,  32750,  United States; Recruiting
Chris Ray  407-596-1119 
Elias Jake Jacobo,  Principal Investigator

      Private Practice, Plantation,  Florida,  33317,  United States; Recruiting
Kathleen Dimeglio  954-587-7010 
Jeffrey Marks,  Principal Investigator

      Advanced Research Institute, New Port Richey,  Florida,  34652,  United States; Recruiting
Susan Randall  727-842-9561 
Ramon Perez-Marrero,  Principal Investigator

      Cleveland Clinic Florida, Fort Lauderdale,  Florida,  33331,  United States; Recruiting
Kim Thomas  954-659-5199 
Daniel Shoskes,  Principal Investigator

Georgia
      Shepard Center, Atlanta,  Georgia,  30309,  United States; Recruiting
Nancy Gilvin  404-367-1392 
Jenelle Foote,  Principal Investigator

Illinois
      Urological Associates, Peoria,  Illinois,  61614,  United States; Recruiting
Diane Koch  309-683-1125 
Jose Hernandez-Graulau,  Principal Investigator

      Evanston Continence Center, Evanston,  Illinois,  60201,  United States; Recruiting
Karen Sasso  847-570-2750 
Peter Sand,  Principal Investigator

      St. Marys Good Samaritan Hospital, Centralia,  Illinois,  62801,  United States; Recruiting
Sonya Mick  618-532-5522 
Edward Stanford,  Principal Investigator

Indiana
      Metropolitan Urology, Jeffersonville,  Indiana,  47130,  United States; Recruiting
Debbie Johnson  812-288-2611 
James Bailen,  Principal Investigator

Michigan
      Wayne State University Urologists, Detroit,  Michigan,  48201,  United States; Recruiting
Claudia Sobieski  313-966-7101 
Ajay Singla,  Principal Investigator

Missouri
      Urological Research Center, St. Louis,  Missouri,  63141,  United States; Recruiting
Stacey Dudkowski  314-996-8507 
Carl Klutke,  Principal Investigator

Nevada
      Private Practice, Henderson,  Nevada,  89014,  United States; Recruiting
Luanna Cunnally  702-454-6226 
Michael Kaplan,  Principal Investigator

New Jersey
      Associates in Urology, West Orange,  New Jersey,  07052,  United States; Recruiting
Kit Murtha  973-325-6100 
Yitzhak Berger,  Principal Investigator

New York
      Upstate Urology, Albany,  New York,  12206,  United States; Recruiting
Linda Abriel  518-446-9838 
Jamie Barada,  Principal Investigator

North Carolina
      McKay Urology, Charlotte,  North Carolina,  28204,  United States; Recruiting
Robbin Clark  704-355-7466 
Michael Kennelly,  Principal Investigator

      Northeast Urology Research, Concord,  North Carolina,  28025,  United States; Recruiting
Wendy Neustrup  704-467-1286 
David Lipsitz,  Principal Investigator

      Women's Health Alliance of the Piedmont, Winston Salem,  North Carolina,  27103,  United States; Recruiting
Donna Miller  336-765-9350 
Robert Lamar Parker,  Principal Investigator

Ohio
      OB-GYN Physicians Inc., Lima,  Ohio,  45805,  United States; Recruiting
Jacqueline Shriver  419-222-1000 
Maurice Chung,  Principal Investigator

Oklahoma
      Private Practice, Tulsa,  Oklahoma,  74104,  United States; Recruiting
Lisa Vaugh  918-878-8431 
John Forrest,  Principal Investigator

      Private Practice, Ponca City,  Oklahoma,  74601,  United States; Recruiting
Leigh Stone  580-765-1969 
Paul Hagood,  Principal Investigator

Oregon
      The Urology Clinic, Portland,  Oregon,  97214,  United States; Recruiting
Anna Swilhart  503-279-8602 
Michael Kaempf,  Principal Investigator

      Private Practice, Medford,  Oregon,  97504,  United States; Recruiting
Debbie Robbins  541-773-5500 
Daniel Laury,  Principal Investigator

Pennsylvania
      Philadelphia Urosurgical Associates, Philadelphia,  Pennsylvania,  19146,  United States; Recruiting
Susan Mauro  215-893-6508 
Kristene Whitmore,  Principal Investigator

Tennessee
      Urology Associates, Nashville,  Tennessee,  37209,  United States; Recruiting
Rick Trotter  615-250-9268 
David Bilhartz,  Principal Investigator

Texas
      Research Across America, Dallas,  Texas,  75234,  United States; Recruiting
Simona Marin  972-241-1222 
Raul Diaz,  Principal Investigator

      Urology San Antonio PA, San Antonio,  Texas,  78229,  United States; Recruiting
Dianna Strange  210-617-4116 
Joan Meaney,  Principal Investigator

      Benchmark Research, Austin,  Texas,  78705,  United States; Recruiting
Ann Rutledge  512-478-5416 
John Horan,  Principal Investigator

Utah
      Private Practice, Ogden,  Utah,  84403,  United States; Recruiting
Carrie Briscoe  801-525-8837 
Brian Heaton,  Principal Investigator

      Middleton Urological Associates, Salt Lake City,  Utah,  84107,  United States; Recruiting
Karen George  801-288-0607 
George Middleton,  Principal Investigator

Virginia
      Virginia Urology, Richmond,  Virginia,  23235,  United States; Recruiting
Janet Sorah  804-288-2785  Ext. 122 
David Glazier,  Principal Investigator

Washington
      Urology Northwest, P.S., Seattle,  Washington,  98133,  United States; Recruiting
Angel Felipa  206-985-8080 
Karny Jacoby,  Principal Investigator

      University of Washington Dept of Urology, Seattle,  Washington,  98195,  United States; Not yet recruiting
Jessica Giesler  206-616-7416 
John Kreiger,  Principal Investigator

Canada, Alberta
      Urogynecology Clinic Royal Alexandra Hospital, Edmonton,  Alberta,  T5H3V9,  Canada; Recruiting
Elizabeth Penttinen  780-491-5647 
Jane Schulz,  Principal Investigator

Canada, British Columbia
      Southern Interior Medical Research Corporation, Kelowna,  British Columbia,  V1Y2H4,  Canada; Recruiting
Joe Husch, RN  250-763-3842 
Thomas Kinahan,  Principal Investigator

      Can-Med Clinical Research Inc, Victoria,  British Columbia,  V8R6T9,  Canada; Recruiting
Chantal Vaillancourt  250-370-2606 
Peter J Pommerville,  Principal Investigator

Canada, New Brunswick
      Dr. Allan Patrick Professional Corp, Fredericton,  New Brunswick,  E3B5B8,  Canada; Recruiting
Rochelle Culley  506-444-9020 
Allan Patrick,  Principal Investigator

Canada, Nova Scotia
      Urology Inc. Valley Professional Center, Kentville,  Nova Scotia,  B4N4K9,  Canada; Recruiting
Liz Palmer  902-679-0536 
Bruce Palmer,  Principal Investigator

Canada, Ontario
      Toronto Urology Study Group/CMX, Toronto,  Ontario,  M6A3B5,  Canada; Recruiting
Shelley Burton  416-256-2737 
Jack Barkin,  Principal Investigator

      Mount Sinai Hospital, Toronto,  Ontario,  M5G1Z5,  Canada; Recruiting
Remiel Rozal  416-586-4617 
Harold Drutz,  Principal Investigator

      Probity Medical Research, Kitchener,  Ontario,  N2M5N4,  Canada; Recruiting
Jeanette Bomhof  519-576-0768 
Russell B Egerdie,  Principal Investigator

      Sunnybrook & Women's College HSC, Toronto,  Ontario,  M4N3M5,  Canada; Recruiting
Divina Buencamino  416-480-6100  Ext. 2309 
Sender Herschorn,  Principal Investigator

      Mor Urology Inc. Bayview Business Center, Newmarket,  Ontario,  L3X1W1,  Canada; Recruiting
Paula Clarke  905-836-4696 
Morrie S Liquornik,  Principal Investigator

      The Urology Resource Center, Burlington,  Ontario,  L7S1V2,  Canada; Recruiting
Jane Love  905-681-9300 
William R Love,  Principal Investigator

      Queen's University, Kingston,  Ontario,  K7L2V7,  Canada; Recruiting
Sylvia Robb  613-549-6666  Ext. 4778 
Curtis Nickel,  Principal Investigator

      The Royal Court Medical Center, Barrie,  Ontario,  L4M4S5,  Canada; Recruiting
Karen Hill  705-727-0551 
Joseph Zadra,  Principal Investigator

More Information

Study ID Numbers:  C-2002-036
Record last reviewed:  November 2004
Record first received:  July 7, 2004
ClinicalTrials.gov Identifier:  NCT00086684
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-16
line
U.S. National Library of Medicine, Contact NLM Customer Service
National Institutes of Health, Department of Health & Human Services
Copyright, Privacy, Accessibility, Freedom of Information Act