Asimadoline for the Treatment of Subjects With Irritable Bowel Syndrome

PHASE2CompletedINTERVENTIONAL
Enrollment

596

Participants

Timeline

Start Date

August 31, 2006

Primary Completion Date

November 30, 2007

Study Completion Date

December 31, 2007

Conditions
Irritable Bowel Syndrome
Interventions
DRUG

Asimadoline

Asimadoline was provided in coated tablets of three dosages (0.15 mg, 0.5 mg, and 1.0 mg). All asimadoline tablets used in this trial were synthesized from the same batch of drug substance (Batch EF418492). Asimadoline was administered orally, BID for 12 weeks

DRUG

Placebo

Placebo was provided in coated tablets identical in appearance to asimadoline tablets.

Trial Locations (112)

10021

Cornell Weill Medical College, New York

11021

Long Island Clinical Research Associates, Great Neck

15212

Allegheny Center for Digestive Health, Pittsburgh

18840

Guthrie Clinical Research, Sayre

20815

Chevy Chase Clinical Research MGG, Chevy Chase

21136

Clinical Associates Research, Reisterstown

21208

Woodholme Gastroenterology Associates, PA, Baltimore

21229

Digestive Diseases Associates, PA, Baltimore

21401

Digestive Disorders Associate, Annapolis

22911

Charlottesville Medical Research, Charlottesville

23294

National Clinical Research Inc, Richmond

24073

New River Valley Research Institute, Christiansburg

27103

Piedmont Medical Research Associates, Winston-Salem

27403

LeBauer research Associates, PA, Greensboro

27511

Cary Medical Research Associates, Cary

27599

UNC Chapel Hill, Chapel Hill

27609

Triangle Medical Research Associates, Raleigh

28144

Crescent Medical Research, Salisbury

28207

Charlotte Gastroenterology and Hepatology, Charlotte

28209

Metrolina Medical Research, Charlotte

28304

Cumberland Research Associates, Fayetteville

28401

Hanover Medical Specialists, PA, Wilmington

28412

New Hannover Medical Research, Wilmington

28601

Unifour Medical Research Associates, Hickory

28801

Asheville Gastroenterology Associates, PA, Asheville

29464

Coastal Carolina Research Center, Mt. Pleasant

Palmetto Medical Research, Mt. Pleasant

29681

Hillcrest Clinical Research, Simpsonville

30067

Michael S. Levine, MD, Marietta

30281

Clinical Research Atlanta, Stockbridge

30318

Mount Vernon Clinical Research, Sandy Springs

32174

Penninsula Research, Inc, Ormond Beach

32607

Florida Medical Research Institute, Gainesville

32833

Universal Clinical Research & Technology, Orlando

33010

Research Consultants Group, Hialeah

33606

Meridien Research, Tampa

33709

Meridien Research, St. Petersburg

33781

Radiant Research - St. Petersburg, Pinellas Park

34233

Lovelace Scientific Resources, Sarasota

34613

Meridian Research, Brooksville

34652

Suncoast Clinical Research, New Port Richey

35801

Medical Affiliated Research Center, Huntsville

37043

Alpha Clinical Research,LLC, Clarksville

37205

Dial Research Associates, Inc, Nashville

37404

ClinSearch, Chattanooga

37660

Gastroenterology Associates, Kingsport

38138

Memphis Gastroenterology Group, Germantown

38654

Olive Branch Family Medical Center, Olive Branch

39202

Gastrointestinal Associates, PA, Jackson

40202

University of Louisville GI Research, Louisville

42431

Commonwealth Biomedical Research, LLC, Madisonville

43212

Radiant Research, Columbus

44260

Radiant Research - Akron, Mogadore

44302

Akron Gastroenterology Assoc, Inc., Akron

45220

Digestive Health Network, Cincinnati

45249

Radiant Research, Cincinnati

45429

Wells Institute for Health Awareness, Kettering

46237

Indianapolis Gastroenterology Research Foundation, Indianapolis

50325

Heartland Medical Research, Inc, Clive

53215

Wisconsin Center for Advanced Research, Milwaukee

55318

Ridgeview Research, Chaska

59102

Montana Health Research Institute, Billings

60005

Northwest Gastroenterologists S.C., Arlington Heights

60452

University Digestive Health Center, Oak Forest

60546

BHS Digestive Disease Associates, Riverside

60622

Illinois Center for Clinical Research, Chicago

61107

Rockford Gastroenterology Associates Ltd, Rockford

63128

St. Louis Center for Clinical Research, St Louis

67203

Professional Research Network of Kansas, Wichita

67207

Heartland Research Associates, LLC, Wichita

68144

Dr. Meera Dewan, PC, Omaha

68198

University of Nebraska Medical Center, Omaha

68503

Gastroenterology Specialties, PC, Lincoln

70809

Digestive Health Center of Louisianna, Baton Rouge

72117

Arkansas Gastroenterology, North Little Rock

73104

Oklahoma Foundation for Digestive Research, Oklahoma City

73701

Lion Research, Norman

74104

Options Health Research, LLC, Tulsa

74136

Castlerock Clinical Research Consultants, LLC, Tulsa

77004

Discovery Alliance, Houston

77036

NationsMed Clinical Research, Houston

77074

Clinical Trials Network, Houston

77304

Sadler Clinic, Conroe

78205

Sun Research Institute, San Antonio

78752

Covance CRU-Austin, Austin

79430

Texas Tech University Health Sciences Center, Lubbock

79905

Texas Tech University Health Sciences Center, El Paso

80033

Western States Clinical Research Inc, Wheat Ridge

80501

Longmont Medical Research Network, Longmont

80909

Lynn Institute of the Rockies, Colorado Springs

84109

J. Lewis Research Inc., Foothills Family Clinic, Salt Lake City

84405

Advanced Research Institute, Ogden

85016

Lovelace Scientific Resources, Pheonix

Lovelace Scientific Resources, Phoenix

85029

Redpoint Research, Phoenix

85259

Mayo Clinic Scottsdale - Division of Gastroenterology, Scottsdale

85741

Genova Clinical Research, Tucson

87106

New Mexico Clinical Research & Osteoporosis Center, Albuquerque

91361

Westlake Medical Research, Westlake Village

92618

Irvine Center for Clinical Research Inc., Irvine

92840

Digestive & Liver Disease Specialists, Garden Grove

92868

Community Clinical Trials, Orange

95758

Sutter Institute for Medical Research, Elk Grove

95816

Sutter Institute for Medical Research, Sacramento

95831

Nothern California Research, Sacramento

97210

NW Gastroenterology Clinic, Portland

97225

West Hills Gastroenterology Associates, PC, Portland

06615

Clinical Research Consultants, LLC, Stratford

06708

Phoenix Internal Medicine Associates, LLC, Waterbury

02215

Beth Israel Deaconess Medical Center, Boston

02747

Northeast Medical Research Associates, North Dartmouth

02917

Safe Harbor Clinical Research, East Providence

Sponsors
All Listed Sponsors
collaborator

RTI Health Solutions

OTHER

lead

Tioga Pharmaceuticals

INDUSTRY

NCT00454688 - Asimadoline for the Treatment of Subjects With Irritable Bowel Syndrome | Biotech Hunter | Biotech Hunter