The purpose of this study is to compare the safety and effectiveness of different doses of an investigational medication in women with severe diarrhea-predominant Irritable Bowel Syndrome (IBS) who have failed conventional therapy.

Condition	Treatment or Intervention	Phase
Irritable Bowel Syndrome	Drug: Investigational IBS Drug	Phase III

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

Criteria

Inclusion Criteria

• women 18 years or older
• diagnosed with severe diarrhea-predominant Irritable Bowel Syndrome (IBS)
• failed conventional therapy
• willing to make daily calls on a touch-tone telephone

Alabama
      Calera,  Alabama,  35040,  United States; Recruiting
      Birmingham,  Alabama,  35235,  United States; Recruiting
      Tuscaloosa,  Alabama,  35406,  United States; Recruiting
Arizona
      Phoenix,  Arizona,  85006,  United States; Recruiting
      Tucson,  Arizona,  85723,  United States; Recruiting
Arkansas
      Fayetteville,  Arkansas,  72701,  United States; Recruiting
California
      Los Angeles,  California,  90045,  United States; Recruiting
      Rancho Cucamonga,  California,  91730,  United States; Recruiting
      Upland,  California,  91786,  United States; Recruiting
      Chula Vista,  California,  91910,  United States; Recruiting
      Vista,  California,  92084,  United States; Recruiting
      San Diego,  California,  92103,  United States; Recruiting
      San Diego,  California,  92123,  United States; Recruiting
      Redlands,  California,  92373,  United States; Recruiting
      Newport Beach,  California,  92663,  United States; Recruiting
      Santa Ana,  California,  92704,  United States; Recruiting
      Santa Ana,  California,  92705,  United States; Recruiting
      Fountain Valley,  California,  92708,  United States; Recruiting
      Garden Grove,  California,  92840,  United States; Recruiting
      Lancaster,  California,  93534,  United States; Recruiting
      San Rafael,  California,  94901,  United States; Recruiting
      Carmichael,  California,  95608,  United States; Recruiting
      Yuba City,  California,  95991,  United States; Recruiting
Colorado
      Wheat Ridge,  Colorado,  80033,  United States; Recruiting
      Englewood,  Colorado,  80113,  United States; Recruiting
      Boulder,  Colorado,  80304,  United States; Recruiting
      Colorado Springs,  Colorado,  80907,  United States; Recruiting
Connecticut
      Manchester,  Connecticut,  06040,  United States; Recruiting
      Stamford,  Connecticut,  06905,  United States; Recruiting
Florida
      Port Orange,  Florida,  32129,  United States; Recruiting
      Tallahassee,  Florida,  32308,  United States; Recruiting
      Panama City,  Florida,  32405,  United States; Recruiting
      Longwood,  Florida,  32779,  United States; Recruiting
      Hialeah,  Florida,  33013,  United States; Recruiting
      Hollywood,  Florida,  33021,  United States; Recruiting
      Coral Gables,  Florida,  33134,  United States; Recruiting
      Miami Beach,  Florida,  33140,  United States; No longer recruiting
      Miami,  Florida,  33156,  United States; No longer recruiting
      Miami,  Florida,  33186,  United States; Recruiting
      West Palm Beach,  Florida,  33407,  United States; Recruiting
      Boynton Beach,  Florida,  33426,  United States; Recruiting
      Boynton Beach,  Florida,  33437,  United States; No longer recruiting
      Lake Worth,  Florida,  33461,  United States; Recruiting
      Boca Raton,  Florida,  33486,  United States; Recruiting
      Boca Raton,  Florida,  33486,  United States; No longer recruiting
      Zephyrhills,  Florida,  33540,  United States; Recruiting
      Tampa,  Florida,  33614,  United States; Recruiting
      St. Petersburg,  Florida,  33702,  United States; No longer recruiting
      Fort Myers,  Florida,  33907,  United States; Recruiting
      Fort Myers,  Florida,  33907,  United States; No longer recruiting
      Fort Myers,  Florida,  33916,  United States; Recruiting
      Naples,  Florida,  34102,  United States; Recruiting
      Sarasota,  Florida,  34232,  United States; Recruiting
      Ocala,  Florida,  34471,  United States; Recruiting
      New Port Richey,  Florida,  34652,  United States; Recruiting
      New Port Richey,  Florida,  34652,  United States; Not yet recruiting
      Stuart,  Florida,  34996,  United States; Not yet recruiting
Georgia
      Decatur,  Georgia,  30033,  United States; Recruiting
      Austell,  Georgia,  30106,  United States; Recruiting
      Stockbridge,  Georgia,  30281,  United States; Recruiting
      Atlanta,  Georgia,  30309,  United States; Recruiting
      Atlanta,  Georgia,  30328,  United States; Recruiting
      Marietta,  Georgia,  30342,  United States; Recruiting
      Atlanta,  Georgia,  30342,  United States; Recruiting
      Martinez,  Georgia,  30907,  United States; Recruiting
      Savannah,  Georgia,  31405,  United States; Recruiting
Illinois
      Riverside,  Illinois,  60546,  United States; Recruiting
      Peoria,  Illinois,  61602,  United States; Recruiting
Indiana
      Indianapolis,  Indiana,  46250,  United States; Recruiting
      Indianapolis,  Indiana,  46254,  United States; Recruiting
      South Bend,  Indiana,  46601,  United States; Recruiting
Iowa
      Davenport,  Iowa,  52807,  United States; Recruiting
Kansas
      Overland Park,  Kansas,  66211,  United States; Recruiting
Kentucky
      Lebanon,  Kentucky,  40033,  United States; Recruiting
      Louisville,  Kentucky,  40202,  United States; Recruiting
      Louisville,  Kentucky,  40291,  United States; Recruiting
      Bowling Green,  Kentucky,  42101,  United States; Recruiting
      Madisonville,  Kentucky,  42431,  United States; Recruiting
Maryland
      Laurel,  Maryland,  20707,  United States; Recruiting
      Silver Spring,  Maryland,  20901,  United States; Recruiting
      Towson,  Maryland,  21204,  United States; Recruiting
      Baltimore,  Maryland,  21215,  United States; No longer recruiting
      Baltimore,  Maryland,  21215,  United States; Recruiting
Massachusetts
      Boston,  Massachusetts,  02114,  United States; Recruiting
      Boston,  Massachusetts,  02215,  United States; Recruiting
      Attleboro,  Massachusetts,  02703,  United States; Recruiting
Michigan
      Warren,  Michigan,  48089,  United States; No longer recruiting
      Ann Arbor,  Michigan,  48109,  United States; Recruiting
      Detroit,  Michigan,  48202,  United States; Recruiting
      Oak Park,  Michigan,  48237,  United States; Recruiting
      Grand Rapids,  Michigan,  49546,  United States; Recruiting
Minnesota
      Chaska,  Minnesota,  55318,  United States; Recruiting
      Plymouth,  Minnesota,  55446,  United States; Recruiting
Mississippi
      Jackson,  Mississippi,  39202,  United States; Recruiting
Missouri
      Wentzville,  Missouri,  63385,  United States; Recruiting
      Kansas City,  Missouri,  64131,  United States; Recruiting
      Jefferson City,  Missouri,  65101,  United States; Recruiting
      Jefferson City,  Missouri,  65109,  United States; Recruiting
Montana
      Missoula,  Montana,  59802,  United States; Recruiting
New Hampshire
      Lebanon,  New Hampshire,  03756,  United States; Recruiting
New Jersey
      Bloomfield,  New Jersey,  07003,  United States; Recruiting
      West Caldwell,  New Jersey,  07006,  United States; Recruiting
      Ocean,  New Jersey,  07712,  United States; Recruiting
      Egg Harbor Township,  New Jersey,  08234,  United States; Recruiting
      Vineland,  New Jersey,  08360,  United States; Recruiting
New Mexico
      Farmington,  New Mexico,  87401,  United States; No longer recruiting
New York
      Great Neck,  New York,  11023,  United States; Recruiting
      Merrick,  New York,  11566,  United States; Recruiting
      Bay Shore,  New York,  11706,  United States; Recruiting
      Stony Brook,  New York,  11794,  United States; Recruiting
      Syracuse,  New York,  13210,  United States; Recruiting
      Rochester,  New York,  14607,  United States; Recruiting
North Carolina
      Winston Salem,  North Carolina,  27103,  United States; Recruiting
      Winston Salem,  North Carolina,  27103,  United States; Recruiting
      Winston Salem,  North Carolina,  27103,  United States; Recruiting
      Winston Salem,  North Carolina,  27103,  United States; Recruiting
      Winston Salem,  North Carolina,  27103,  United States; Recruiting
      High Point,  North Carolina,  27262,  United States; Recruiting
      Greensboro,  North Carolina,  27408,  United States; Recruiting
      Cary,  North Carolina,  27511,  United States; Recruiting
      Morehead City,  North Carolina,  27511,  United States; Recruiting
      Chapel Hill,  North Carolina,  27514,  United States; Recruiting
      Raleigh,  North Carolina,  27609,  United States; Recruiting
      Greenville,  North Carolina,  27834,  United States; Recruiting
      Greenville,  North Carolina,  27858,  United States; Recruiting
      Charlotte,  North Carolina,  28262,  United States; Recruiting
      Fayetteville,  North Carolina,  28304,  United States; Recruiting
      Hickory,  North Carolina,  28601,  United States; Recruiting
      Asheville,  North Carolina,  28801,  United States; Recruiting
North Dakota
      Bismarck,  North Dakota,  58501,  United States; Recruiting
Ohio
      Thornville,  Ohio,  43076,  United States; No longer recruiting
      Columbus,  Ohio,  43212,  United States; Recruiting
      Sylvania,  Ohio,  43560,  United States; Recruiting
      Cleveland,  Ohio,  44106,  United States; Recruiting
      Cleveland,  Ohio,  44113,  United States; Recruiting
      Lyndhurst,  Ohio,  44124,  United States; Recruiting
      Akron,  Ohio,  44302,  United States; Recruiting
      Cincinnati,  Ohio,  45219,  United States; Recruiting
      Cincinnati,  Ohio,  45220,  United States; Recruiting
      Cincinnati,  Ohio,  45224,  United States; Recruiting
      Kettering,  Ohio,  45429,  United States; Recruiting
      Beavercreek,  Ohio,  45431,  United States; Recruiting
      Dayton,  Ohio,  45440,  United States; Recruiting
      Centerville,  Ohio,  45459,  United States; Recruiting
Oklahoma
      Oklahoma City,  Oklahoma,  73104,  United States; Recruiting
      Oklahoma City,  Oklahoma,  73112,  United States; Recruiting
      Oklahoma City,  Oklahoma,  73112,  United States; Recruiting
      Tulsa,  Oklahoma,  74136,  United States; Recruiting
Oregon
      Medford,  Oregon,  97504,  United States; Recruiting
Pennsylvania
      Pittsburgh,  Pennsylvania,  15212,  United States; Recruiting
      Altoona,  Pennsylvania,  16602,  United States; Recruiting
      Hershey,  Pennsylvania,  17033,  United States; Not yet recruiting
      Newtown,  Pennsylvania,  18940,  United States; Recruiting
      Wynnewood,  Pennsylvania,  19096,  United States; Recruiting
      Fleetwood,  Pennsylvania,  19522,  United States; Recruiting
      Wyomissing,  Pennsylvania,  19610,  United States; Recruiting
Rhode Island
      East Providence,  Rhode Island,  02914,  United States; Recruiting
South Carolina
      Columbia,  South Carolina,  29203,  United States; Recruiting
      Greenville,  South Carolina,  29615,  United States; Recruiting
      Simpsonville,  South Carolina,  29681,  United States; Recruiting
Tennessee
      Murfreesboro,  Tennessee,  37130,  United States; Recruiting
      Nashville,  Tennessee,  37203,  United States; Recruiting
      Chattanooga,  Tennessee,  37404,  United States; Recruiting
      Kingsport,  Tennessee,  37660,  United States; Recruiting
      Memphis,  Tennessee,  38119,  United States; Recruiting
      Memphis,  Tennessee,  38120,  United States; Recruiting
Texas
      Irving,  Texas,  75061,  United States; Recruiting
      Corsicana,  Texas,  75110,  United States; Recruiting
      Dallas,  Texas,  75246,  United States; Recruiting
      Arlington,  Texas,  76012,  United States; Recruiting
      Houston,  Texas,  77002,  United States; Recruiting
      Houston,  Texas,  77024,  United States; Recruiting
      Houston,  Texas,  77025,  United States; Recruiting
      Houston,  Texas,  77030,  United States; Recruiting
      Houston,  Texas,  77030,  United States; Recruiting
      Tomball,  Texas,  77375,  United States; Recruiting
      Conroe,  Texas,  77384,  United States; Recruiting
      Spring,  Texas,  77386,  United States; Recruiting
      San Antonio,  Texas,  78205,  United States; Recruiting
      San Antonio,  Texas,  78229,  United States; Recruiting
      Corpus Christi,  Texas,  78411,  United States; Recruiting
      Austin,  Texas,  78745,  United States; Recruiting
Utah
      Bountiful,  Utah,  84010,  United States; Recruiting
      West Jordan,  Utah,  84088,  United States; Recruiting
      Ogden,  Utah,  84405,  United States; Recruiting
Virginia
      Alexandria,  Virginia,  22304,  United States; Recruiting
      Charlottesville,  Virginia,  22908,  United States; Recruiting
      Charlottesville,  Virginia,  22911,  United States; Recruiting
      Chesapeake,  Virginia,  23320,  United States; Recruiting
Washington
      Renton,  Washington,  98055,  United States; No longer recruiting
      Lacey,  Washington,  98516,  United States; Recruiting
      Wenatchee,  Washington,  98801,  United States; Recruiting
      Yakima,  Washington,  98902,  United States; Recruiting
      Spokane,  Washington,  99207,  United States; Recruiting
      Spokane,  Washington,  99208,  United States; Recruiting
      Walla Walla,  Washington,  99362,  United States; Recruiting
Wisconsin
      Milwaukee,  Wisconsin,  53207,  United States; Recruiting
      Milwaukee,  Wisconsin,  53209,  United States; Recruiting
      Milwaukee,  Wisconsin,  53212,  United States; Recruiting
      Milwaukee,  Wisconsin,  53215,  United States; Recruiting
      Milwaukee,  Wisconsin,  53226,  United States; Recruiting

Study ID Numbers:  S3B30040
Record last reviewed:  July 2004
Record first received:  August 21, 2003
ClinicalTrials.gov Identifier:  NCT00067561
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10