This study will evaluate the effectiveness and safety of the investigational drug talnetant in treating subjects with IBS.

Condition	Treatment or Intervention	Phase
Irritable Bowel Syndrome	Drug: talnetant	Phase II

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

Criteria

Inclusion criteria:

• Subjects will be required to conduct self-assessments of their IBS symptoms using a touch-tone telephone system for the duration of the study (15 weeks).
• Must be diagnosed with IBS consistent with the Rome II criteria.
• Must have normal results from a colonic procedure within 2 years of randomization.
• Must have conducted self-assessments on at least 12 days and have a documented average IBS pain or discomfort score of greater than or equal to 1.5 during the two-week screening phase.

Exclusion criteria:

• Self-assessment of no stool for 7 days during the two-week screening phase.
• Clinically significant abnormal laboratory tests.
• Current evidence or history of various conditions, comorbidities, or surgies such as Irritable Bowel Disease (IBD), gastrointestinal surgeries, and diverticulitis.
• Inability to use the touch-tone telephone system.
• Hypersensitivity to quinolone antibiotics or quinolone derivatives.
• Diagnosis of a psychiatric disorder within the past 2 years and not on a stable dose of medication for at least 6 months.
• Women who are pregnant, breast feeding, or planning to become pregnant during the study.

Permitted medications: The subject is allowed to take any of the following medications, provided they maintain a stable dose for at least 30 days prior to the Screening visit and throughout the remainder of the study:

• Antidepressants, except Remeron
• Antihypercholesterolemics
• Iron supplements
• Bulking agents
• Fiber supplement
• Thyroid replacement therapy (levothyroxine)
• Antipsychotics
• Cox-2 inhibitors (Celebrex)

Prohibited medications: Subjects must stop taking any medications they are taking to treat their IBS symptoms and must not have taken any of the prohibited medications at least 7 days prior to the Screening visit and must remain off these medications for the duration of the study.

• Anticholinergics (dicyclomine, hyoscyamine, propantheline)
• Cholinomimetic (bethanechol, pyridostigmine, tacrine, physostigmine)
• All narcotics (morphine, codeine, tylenol #3, propoxphene, either alone or in combination)
• Tramadol hydrochloride (Ultram)
• Colchicine
• Orlistat (Xenical)
• Misoprostol, alone or in combination (Arthrotec, Cytotec)
• 5-HT3 receptor antagonists (ondansetron, tripisetron, dolasetron, granisetron, mertaxapione, cilansetron, alosetron)
• Tegaserod (Zelnorm)
• Gabapentin
• Lupron
• Antacids containing magnesium or aluminium
• Antidiarrheal agents
• Bismuth compounds
• Prokinetic agents (cisapride, metoclopramide)
• Sulfasalazine
• Laxatives
• Cholestyramine

Arizona
      Study Site 011403, Phoenix,  Arizona,  85016,  United States; Not yet recruiting
      Study Site 011793, Chandler,  Arizona,  85224,  United States; Not yet recruiting
      Study Site 009499, Chandler,  Arizona,  85225,  United States; Recruiting
      Study Site 009637, Scottsdale,  Arizona,  85249,  United States; Not yet recruiting
Arkansas
      Study Site 009579, N. Little Rock,  Arkansas,  72117,  United States; Recruiting
California
      Study Site 009513, Torrance,  California,  90505,  United States; Recruiting
      Study Site 009510, Spring Valley,  California,  91978,  United States; Recruiting
      Study Site 009511, Orange,  California,  92626,  United States; Recruiting
      Study Site 009633, Garden Grove,  California,  92840,  United States; Recruiting
      Study Site 009582, Concord,  California,  94520,  United States; Recruiting
      Study Site 009509, Carmichael,  California,  95608,  United States; Recruiting
      Study Site 009608, Roseville,  California,  95661,  United States; Recruiting
Colorado
      Study Site 009611, Wheat Ridge,  Colorado,  80033,  United States; Recruiting
      Study Site 010918, Centennial,  Colorado,  80112,  United States; Not yet recruiting
      Study Site 009512, Boulder,  Colorado,  80304,  United States; Recruiting
Connecticut
      Study Site 012473, Bristol,  Connecticut,  06010,  United States; Not yet recruiting
      Study Site 009625, Torrington,  Connecticut,  06790,  United States; Recruiting
      Study Site 012167, Stamford,  Connecticut,  06905,  United States; Not yet recruiting
Delaware
      Study Site 009495, Newark,  Delaware,  19713,  United States; Not yet recruiting
Florida
      Study Site 010953, Deland,  Florida,  32720,  United States; Not yet recruiting
      Study Site 009498, Miami,  Florida,  33173,  United States; Recruiting
      Study Site 009492, St. Petersburg,  Florida,  33707,  United States; Recruiting
      Study Site 009589, St. Petersburg,  Florida,  33709,  United States; Recruiting
Georgia
      Study Site 009614, Atlanta,  Georgia,  30328,  United States; Recruiting
Illinois
      Study Site 009502, Berwyn,  Illinois,  60402,  United States; Not yet recruiting
      Study Site 009620, Rockford,  Illinois,  61107,  United States; Recruiting
Indiana
      Study Site 009587, Indianapolis,  Indiana,  46237,  United States; Recruiting
Kentucky
      Study Site 009630, Louisville,  Kentucky,  40202,  United States; Not yet recruiting
Louisiana
      Study Site 009619, Slidell,  Louisiana,  70458,  United States; Not yet recruiting
Maryland
      Study Site 011659, Silver Spring,  Maryland,  20901,  United States; Not yet recruiting
Massachusetts
      Study Site 009825, Springfield,  Massachusetts,  01107,  United States; Recruiting
      Study Site 010628, Salisbury,  Massachusetts,  01915,  United States; Recruiting
      Study Site 009634, Boston,  Massachusetts,  02118,  United States; Not yet recruiting
Michigan
      Study Site 009641, Chesterfield,  Michigan,  48047,  United States; Not yet recruiting
      Study Site 012457, St. Joseph,  Michigan,  49085,  United States; Not yet recruiting
Minnesota
      Study Site 009831, Chaska,  Minnesota,  55318,  United States; Recruiting
Missouri
      Study Site 009607, St. Louis,  Missouri,  63376,  United States; Recruiting
Nebraska
      Study Site 009584, Omaha,  Nebraska,  68144,  United States; Recruiting
      Study Site 009514, Lincoln,  Nebraska,  68503,  United States; Not yet recruiting
New Jersey
      Study Site 009638, Blackwood,  New Jersey,  08012,  United States; Recruiting
New York
      Study Site 009636, Bronx,  New York,  10461,  United States; Not yet recruiting
      Study Site 009621, Great Neck,  New York,  11021,  United States; Recruiting
      Study Site 012470, East Syracuse,  New York,  13057,  United States; Not yet recruiting
      Study Site 009516, Rochester,  New York,  14607,  United States; Recruiting
      Study Site 009931, Rochester,  New York,  14609,  United States; Recruiting
North Carolina
      Study Site 011789, Winston Salem,  North Carolina,  27103,  United States; Not yet recruiting
      Study Site 009826, Greensboro,  North Carolina,  27403,  United States; Recruiting
      Study Site 009586, Chapel Hill,  North Carolina,  27599,  United States; Not yet recruiting
      Study Site 009578, Raleigh,  North Carolina,  27612,  United States; Recruiting
      Study Site 009386, Wilmington,  North Carolina,  28401,  United States; Recruiting
Ohio
      Study Site 009627, Akron,  Ohio,  44302,  United States; Recruiting
      Study Site 0012491, Cincinnati,  Ohio,  45242,  United States; Not yet recruiting
      Study Site 009493, Kettering,  Ohio,  45429,  United States; Recruiting
Oklahoma
      Study Site 009612, Oklahoma City,  Oklahoma,  73112,  United States; Recruiting
Oregon
      Study Site 009623, Portland,  Oregon,  97225,  United States; Not yet recruiting
      Study Site 009628, Eugene,  Oregon,  97401,  United States; Not yet recruiting
      Study Site 009613, Medford,  Oregon,  97504,  United States; Not yet recruiting
Pennsylvania
      Study Site 009830, Hershey,  Pennsylvania,  17033,  United States; No longer recruiting
South Carolina
      Study Site 009515, Greer,  South Carolina,  29651,  United States; Recruiting
Tennessee
      Study Site 009639, Chattanooga,  Tennessee,  37404,  United States; Recruiting
      Study Site 009384, Bristol,  Tennessee,  37620,  United States; Recruiting
      Study Site 009629, Memphis,  Tennessee,  38119,  United States; Recruiting
      Study Site 009508, Memphis,  Tennessee,  38120,  United States; Recruiting
Texas
      Study Site 009517, San Antonio,  Texas,  78209,  United States; Recruiting
      Study Site 009617, Austin,  Texas,  78745,  United States; Recruiting
      Study Site 009631, El Paso,  Texas,  79905,  United States; Not yet recruiting
Virginia
      Study Site 009491, Charlottesville,  Virginia,  22911,  United States; Recruiting
      Study Site 009497, Christiansburg,  Virginia,  24073,  United States; Not yet recruiting
Canada, Alberta
      Edmonton,  Alberta,  T5G 2C8,  Canada; Not yet recruiting
Canada, Nova Scotia
      Truro,  Nova Scotia,  B2N 1L2,  Canada; Not yet recruiting
      Halifax,  Nova Scotia,  B3H1V7,  Canada; Recruiting
Canada, Ontario
      Mississauga,  Ontario,  L5B 1N1,  Canada; Recruiting
      Toronto,  Ontario,  M3J 1N2,  Canada; Recruiting
      Toronto,  Ontario,  M3N 2V7,  Canada; Recruiting
      Toronto,  Ontario,  M9W 4L6,  Canada; Recruiting
      Sudbury,  Ontario,  P3E 6B4,  Canada; Recruiting
Canada, Quebec
      Quebec City,  Quebec,  G1S 4L8,  Canada; Not yet recruiting
      Montreal,  Quebec,  H2X 3J4,  Canada; Not yet recruiting
      Point Claire,  Quebec,  H9R 4S3,  Canada; Recruiting
      Sherbrooke,  Quebec,  J1H 1Z1,  Canada; Recruiting
      Sherbrooke,  Quebec,  J1H 5N4,  Canada; Not yet recruiting
      Saint-Jerome,  Quebec,  J7Z 5T3,  Canada; Recruiting
Canada, Saskatchewan
      Saskatoon,  Saskatchewan,  S7K 1J5,  Canada; Recruiting

Study ID Numbers:  223412/068
Record last reviewed:  January 2005
Last Updated:  January 18, 2005
Record first received:  January 18, 2005
ClinicalTrials.gov Identifier:  NCT00101985
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08