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Asimadoline for the Treatment of Subjects With Irritable Bowel Syndrome

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Asimadoline
Placebo
Sponsored by
Tioga Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Irritable Bowel Syndrome, Asimadoline

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Males and females aged 18-79
  • Must sign an ICF
  • Females of childbearing potential must have a negative pregnancy test at screening and must adhere to contraception throughout the trial
  • Must have been diagnosed with IBS as a result of having at least 6 months, not necessarily consecutive, in the preceding 12 months of recurrent symptoms of abdominal discomfort or pain associated with at least 2 of the following: 1)relieved with defecation; 2)onset associated with a change in stool frequency; 3)onset associated with a change in stool form
  • Must demonstrate a willingness to comply with daily telephone diary entry

Exclusion Criteria:

  • Any subject with evidence of a biochemical or structural abnormality of the digestive tract or other co-morbid illness that might impact the ability to interpret the safety and efficacy data
  • Pregnant or breastfeeding females
  • Refusal to discontinue prohibited concomitant medications
  • Use of an investigational drug or participation in an investigational study within 30 days of screening
  • Inability or unwillingness to use the touch-tone telephone data entry system

Sites / Locations

  • Medical Affiliated Research Center
  • Lovelace Scientific Resources
  • Lovelace Scientific Resources
  • Redpoint Research
  • Mayo Clinic Scottsdale - Division of Gastroenterology
  • Genova Clinical Research
  • Arkansas Gastroenterology
  • Sutter Institute for Medical Research
  • Digestive & Liver Disease Specialists
  • Irvine Center for Clinical Research Inc.
  • Community Clinical Trials
  • Sutter Institute for Medical Research
  • Nothern California Research
  • Westlake Medical Research
  • Lynn Institute of the Rockies
  • Longmont Medical Research Network
  • Western States Clinical Research Inc
  • Clinical Research Consultants, LLC
  • Phoenix Internal Medicine Associates, LLC
  • Meridian Research
  • Florida Medical Research Institute
  • Research Consultants Group
  • Suncoast Clinical Research
  • Universal Clinical Research & Technology
  • Penninsula Research, Inc
  • Radiant Research - St. Petersburg
  • Lovelace Scientific Resources
  • Meridien Research
  • Meridien Research
  • Michael S. Levine, MD
  • Mount Vernon Clinical Research
  • Clinical Research Atlanta
  • Northwest Gastroenterologists S.C.
  • Illinois Center for Clinical Research
  • University Digestive Health Center
  • BHS Digestive Disease Associates
  • Rockford Gastroenterology Associates Ltd
  • Indianapolis Gastroenterology Research Foundation
  • Heartland Medical Research, Inc
  • Professional Research Network of Kansas
  • Heartland Research Associates, LLC
  • University of Louisville GI Research
  • Commonwealth Biomedical Research, LLC
  • Digestive Health Center of Louisianna
  • Digestive Disorders Associate
  • Woodholme Gastroenterology Associates, PA
  • Digestive Diseases Associates, PA
  • Chevy Chase Clinical Research MGG
  • Clinical Associates Research
  • Beth Israel Deaconess Medical Center
  • Northeast Medical Research Associates
  • Ridgeview Research
  • Gastrointestinal Associates, PA
  • Olive Branch Family Medical Center
  • St. Louis Center for Clinical Research
  • Montana Health Research Institute
  • Gastroenterology Specialties, PC
  • Dr. Meera Dewan, PC
  • University of Nebraska Medical Center
  • New Mexico Clinical Research & Osteoporosis Center
  • Long Island Clinical Research Associates
  • Cornell Weill Medical College
  • Asheville Gastroenterology Associates, PA
  • Cary Medical Research Associates
  • UNC Chapel Hill
  • Charlotte Gastroenterology and Hepatology
  • Metrolina Medical Research
  • Cumberland Research Associates
  • LeBauer research Associates, PA
  • Unifour Medical Research Associates
  • Triangle Medical Research Associates
  • Crescent Medical Research
  • Hanover Medical Specialists, PA
  • New Hannover Medical Research
  • Piedmont Medical Research Associates
  • Akron Gastroenterology Assoc, Inc.
  • Digestive Health Network
  • Radiant Research
  • Radiant Research
  • Wells Institute for Health Awareness
  • Radiant Research - Akron
  • Lion Research
  • Oklahoma Foundation for Digestive Research
  • Options Health Research, LLC
  • Castlerock Clinical Research Consultants, LLC
  • NW Gastroenterology Clinic
  • West Hills Gastroenterology Associates, PC
  • Allegheny Center for Digestive Health
  • Guthrie Clinical Research
  • Safe Harbor Clinical Research
  • Coastal Carolina Research Center
  • Palmetto Medical Research
  • Hillcrest Clinical Research
  • ClinSearch
  • Alpha Clinical Research,LLC
  • Memphis Gastroenterology Group
  • Gastroenterology Associates
  • Dial Research Associates, Inc
  • Covance CRU-Austin
  • Sadler Clinic
  • Texas Tech University Health Sciences Center
  • Discovery Alliance
  • NationsMed Clinical Research
  • Clinical Trials Network
  • Texas Tech University Health Sciences Center
  • Sun Research Institute
  • Advanced Research Institute
  • J. Lewis Research Inc., Foothills Family Clinic
  • Charlottesville Medical Research
  • New River Valley Research Institute
  • National Clinical Research Inc
  • Wisconsin Center for Advanced Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo

Asimadoline 0.15 mg

Asimadoline 0.5 mg

Asimadoline 1.0 mg

Arm Description

Outcomes

Primary Outcome Measures

Relief of IBS Pain - total months
The primary efficacy endpoint of the study was the total number of months with adequate relief of IBS pain or discomfort.

Secondary Outcome Measures

Relief of IBS Pain - percent of patients
Proportion of subjects with adequate relief of IBS pain or discomfort
Relief of IBS Symptoms
Adequate relief of IBS symptoms
Lower GI function - change from baseline
Change from baseline in assessments of lower gastrointestinal (GI) function (i.e., stool frequency, stool consistency, urgency, bloating, and straining)
Abdominal Pain Score - change from baseline
Change from baseline in abdominal pain score
Abdominal Discomfort Score - change from baseline
Change from baseline in abdominal discomfort score

Full Information

First Posted
March 29, 2007
Last Updated
October 17, 2011
Sponsor
Tioga Pharmaceuticals
Collaborators
RTI Health Solutions
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1. Study Identification

Unique Protocol Identification Number
NCT00454688
Brief Title
Asimadoline for the Treatment of Subjects With Irritable Bowel Syndrome
Official Title
A 12-Week, Randomized, Double-Blind, Dose-Ranging, Placebo-Controlled Study of Asimadoline in Subjects With Irritable Bowel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tioga Pharmaceuticals
Collaborators
RTI Health Solutions

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety and efficacy of different doses of asimadoline in the treatment of patients with irritable bowel syndrome.
Detailed Description
A randomized, dose-ranging, double-blind, placebo-controlled study designed to evaluate the efficacy and tolerability of three dose levels of asimadoline in subjects with IBS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
Irritable Bowel Syndrome, Asimadoline

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
596 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Asimadoline 0.15 mg
Arm Type
Experimental
Arm Title
Asimadoline 0.5 mg
Arm Type
Experimental
Arm Title
Asimadoline 1.0 mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Asimadoline
Other Intervention Name(s)
EMD 61753, EMR 63320
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo was provided in coated tablets identical in appearance to asimadoline tablets.
Primary Outcome Measure Information:
Title
Relief of IBS Pain - total months
Description
The primary efficacy endpoint of the study was the total number of months with adequate relief of IBS pain or discomfort.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Relief of IBS Pain - percent of patients
Description
Proportion of subjects with adequate relief of IBS pain or discomfort
Time Frame
12 weeks
Title
Relief of IBS Symptoms
Description
Adequate relief of IBS symptoms
Time Frame
12 weeks
Title
Lower GI function - change from baseline
Description
Change from baseline in assessments of lower gastrointestinal (GI) function (i.e., stool frequency, stool consistency, urgency, bloating, and straining)
Time Frame
12 weeks
Title
Abdominal Pain Score - change from baseline
Description
Change from baseline in abdominal pain score
Time Frame
12 weeks
Title
Abdominal Discomfort Score - change from baseline
Description
Change from baseline in abdominal discomfort score
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males and females aged 18-79 Must sign an ICF Females of childbearing potential must have a negative pregnancy test at screening and must adhere to contraception throughout the trial Must have been diagnosed with IBS as a result of having at least 6 months, not necessarily consecutive, in the preceding 12 months of recurrent symptoms of abdominal discomfort or pain associated with at least 2 of the following: 1)relieved with defecation; 2)onset associated with a change in stool frequency; 3)onset associated with a change in stool form Must demonstrate a willingness to comply with daily telephone diary entry Exclusion Criteria: Any subject with evidence of a biochemical or structural abnormality of the digestive tract or other co-morbid illness that might impact the ability to interpret the safety and efficacy data Pregnant or breastfeeding females Refusal to discontinue prohibited concomitant medications Use of an investigational drug or participation in an investigational study within 30 days of screening Inability or unwillingness to use the touch-tone telephone data entry system
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allen Mangel, MD, PhD
Organizational Affiliation
Tioga Pharmaceuticals
Official's Role
Study Chair
Facility Information:
Facility Name
Medical Affiliated Research Center
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Lovelace Scientific Resources
City
Pheonix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Lovelace Scientific Resources
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Redpoint Research
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85029
Country
United States
Facility Name
Mayo Clinic Scottsdale - Division of Gastroenterology
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Genova Clinical Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
Arkansas Gastroenterology
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Facility Name
Sutter Institute for Medical Research
City
Elk Grove
State/Province
California
ZIP/Postal Code
95758
Country
United States
Facility Name
Digestive & Liver Disease Specialists
City
Garden Grove
State/Province
California
ZIP/Postal Code
92840
Country
United States
Facility Name
Irvine Center for Clinical Research Inc.
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
Facility Name
Community Clinical Trials
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Sutter Institute for Medical Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Nothern California Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95831
Country
United States
Facility Name
Westlake Medical Research
City
Westlake Village
State/Province
California
ZIP/Postal Code
91361
Country
United States
Facility Name
Lynn Institute of the Rockies
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Longmont Medical Research Network
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Facility Name
Western States Clinical Research Inc
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Clinical Research Consultants, LLC
City
Stratford
State/Province
Connecticut
ZIP/Postal Code
06615
Country
United States
Facility Name
Phoenix Internal Medicine Associates, LLC
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Meridian Research
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34613
Country
United States
Facility Name
Florida Medical Research Institute
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Research Consultants Group
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33010
Country
United States
Facility Name
Suncoast Clinical Research
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Universal Clinical Research & Technology
City
Orlando
State/Province
Florida
ZIP/Postal Code
32833
Country
United States
Facility Name
Penninsula Research, Inc
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Radiant Research - St. Petersburg
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Lovelace Scientific Resources
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34233
Country
United States
Facility Name
Meridien Research
City
St Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
Meridien Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Michael S. Levine, MD
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30067
Country
United States
Facility Name
Mount Vernon Clinical Research
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Facility Name
Clinical Research Atlanta
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
Northwest Gastroenterologists S.C.
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Facility Name
Illinois Center for Clinical Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60622
Country
United States
Facility Name
University Digestive Health Center
City
Oak Forest
State/Province
Illinois
ZIP/Postal Code
60452
Country
United States
Facility Name
BHS Digestive Disease Associates
City
Riverside
State/Province
Illinois
ZIP/Postal Code
60546
Country
United States
Facility Name
Rockford Gastroenterology Associates Ltd
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61107
Country
United States
Facility Name
Indianapolis Gastroenterology Research Foundation
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
Heartland Medical Research, Inc
City
Clive
State/Province
Iowa
ZIP/Postal Code
50325
Country
United States
Facility Name
Professional Research Network of Kansas
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67203
Country
United States
Facility Name
Heartland Research Associates, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
University of Louisville GI Research
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Commonwealth Biomedical Research, LLC
City
Madisonville
State/Province
Kentucky
ZIP/Postal Code
42431
Country
United States
Facility Name
Digestive Health Center of Louisianna
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Digestive Disorders Associate
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Woodholme Gastroenterology Associates, PA
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21208
Country
United States
Facility Name
Digestive Diseases Associates, PA
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Facility Name
Chevy Chase Clinical Research MGG
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Clinical Associates Research
City
Reisterstown
State/Province
Maryland
ZIP/Postal Code
21136
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Northeast Medical Research Associates
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
Ridgeview Research
City
Chaska
State/Province
Minnesota
ZIP/Postal Code
55318
Country
United States
Facility Name
Gastrointestinal Associates, PA
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
Olive Branch Family Medical Center
City
Olive Branch
State/Province
Mississippi
ZIP/Postal Code
38654
Country
United States
Facility Name
St. Louis Center for Clinical Research
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Montana Health Research Institute
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
Gastroenterology Specialties, PC
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68503
Country
United States
Facility Name
Dr. Meera Dewan, PC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
New Mexico Clinical Research & Osteoporosis Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Long Island Clinical Research Associates
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Cornell Weill Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Asheville Gastroenterology Associates, PA
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Cary Medical Research Associates
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27511
Country
United States
Facility Name
UNC Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Charlotte Gastroenterology and Hepatology
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Metrolina Medical Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
Cumberland Research Associates
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
Country
United States
Facility Name
LeBauer research Associates, PA
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Facility Name
Unifour Medical Research Associates
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
Triangle Medical Research Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Crescent Medical Research
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Hanover Medical Specialists, PA
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
New Hannover Medical Research
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28412
Country
United States
Facility Name
Piedmont Medical Research Associates
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Akron Gastroenterology Assoc, Inc.
City
Akron
State/Province
Ohio
ZIP/Postal Code
44302
Country
United States
Facility Name
Digestive Health Network
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Facility Name
Radiant Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45249
Country
United States
Facility Name
Radiant Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
Wells Institute for Health Awareness
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Radiant Research - Akron
City
Mogadore
State/Province
Ohio
ZIP/Postal Code
44260
Country
United States
Facility Name
Lion Research
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73701
Country
United States
Facility Name
Oklahoma Foundation for Digestive Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Options Health Research, LLC
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Castlerock Clinical Research Consultants, LLC
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
NW Gastroenterology Clinic
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
West Hills Gastroenterology Associates, PC
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Allegheny Center for Digestive Health
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Guthrie Clinical Research
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Facility Name
Safe Harbor Clinical Research
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02917
Country
United States
Facility Name
Coastal Carolina Research Center
City
Mt. Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Palmetto Medical Research
City
Mt. Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Hillcrest Clinical Research
City
Simpsonville
State/Province
South Carolina
ZIP/Postal Code
29681
Country
United States
Facility Name
ClinSearch
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Alpha Clinical Research,LLC
City
Clarksville
State/Province
Tennessee
ZIP/Postal Code
37043
Country
United States
Facility Name
Memphis Gastroenterology Group
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Gastroenterology Associates
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Dial Research Associates, Inc
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Covance CRU-Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78752
Country
United States
Facility Name
Sadler Clinic
City
Conroe
State/Province
Texas
ZIP/Postal Code
77304
Country
United States
Facility Name
Texas Tech University Health Sciences Center
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
Country
United States
Facility Name
Discovery Alliance
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
NationsMed Clinical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77036
Country
United States
Facility Name
Clinical Trials Network
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Texas Tech University Health Sciences Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79430
Country
United States
Facility Name
Sun Research Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78205
Country
United States
Facility Name
Advanced Research Institute
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
J. Lewis Research Inc., Foothills Family Clinic
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84109
Country
United States
Facility Name
Charlottesville Medical Research
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States
Facility Name
New River Valley Research Institute
City
Christiansburg
State/Province
Virginia
ZIP/Postal Code
24073
Country
United States
Facility Name
National Clinical Research Inc
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
Wisconsin Center for Advanced Research
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Asimadoline for the Treatment of Subjects With Irritable Bowel Syndrome

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