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Study of Asimadoline to Treat Diarrhea-Predominant Irritable Bowel Syndrome (D-IBS)

Primary Purpose

Diarrhea Predominant Irritable Bowel Syndrome

Status
Completed
Phase
Phase 3
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 Diarrhea Predominant Irritable Bowel Syndrome focused on measuring diarrhea predominant irritable bowel syndrome

Eligibility Criteria

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

Inclusion Criteria:

  1. Signs and dates a written informed consent form.
  2. Male and female subjects aged 18-79 who are fluent in English
  3. All subjects must use protocol specified contraceptive measures

  4. The subject is or has been diagnosed with IBS with symptom onset at least 6 months prior to diagnosis. IBS is defined as the subject having recurrent abdominal pain or discomfort at least 3 days per month in the past 3 months associated with at least two of the following symptoms:

    Improvement with defecation Onset associated with a change in frequency of stool Onset associated with a change in form (appearance) of stool

  5. The subject has been diagnosed with diarrhea-predominant IBS
  6. Within 2 years of the randomization visit, the subject has normal results from a flexible sigmoidoscopy, a colonoscopy, or a barium enema plus flexible sigmoidoscopy, according to the subject's age by a specified algorithm.

Exclusion Criteria:

  1. The subject exhibits evidence of a biochemical or structural abnormality of the digestive tract.
  2. Subject has a concurrent illness or disability (excluding IBS) that may affect the interpretation of clinical efficacy and/or safety data or otherwise contraindicates participation in this clinical study (e.g., an unstable cardiovascular, renal, hepatic, pulmonary, endocrine, metabolic, GI, hematological, or neurological condition).
  3. The subject has a family history of prolonged QT syndrome.
  4. The subject has been diagnosed with a major psychiatric disorder.
  5. The subject has a history of alcohol or substance abuse within the past 2 years.
  6. The subject has a history or current evidence of laxative abuse
  7. The subject has a positive stool sample for ova or parasite.
  8. The subject has used an investigational drug or participated in an investigational study within 30 days of screening.
  9. The subject refuses to discontinue one (or more) prohibited medications at least 7 days prior to the screening visit.
  10. The subject refuses to maintain a stable dose of one (or more) allowable concurrent medications for at least 30 days prior to the screening visit.
  11. The subject is a pregnant woman or a woman who is breast feeding.
  12. The subject is unable or unwilling to follow directions or use the electronic diary system.

Sites / Locations

  • North Alabama Research Center, LLC
  • Alliance Clinical Research
  • Medical Affliated Research Center, Inc.
  • Saadat Ansari MD LLC
  • Connect Clinical Research Center
  • Digestive Health Research Unit
  • Adobe Clinical Research, LLC
  • ACRC/Arizona Clinical Research Center, Inc.
  • Genova Clinical Research
  • W/C Clinical Research
  • Lynn Institute of the Ozarks
  • Applied Research Center of Arkansas
  • Arkansas Gastroenterology
  • Providence Clinical Research
  • GW Research Inc,
  • La Jolla Clinical Research, Inc
  • Discovery Clinical Research
  • Digestive & Liver Disease Specialist
  • Collaborative Neuroscience Network Inc
  • California Gastroenterology Associates
  • Community Clinical Trials
  • Sutter Medical Group Gastroenterology
  • Medical Center for Clinical Research
  • Medical Associates Research Group, Inc.
  • Westlake Medical Research
  • Lynne Institute of the Rockies
  • Arapahoe Gastroenterology
  • Lynn Institute of Pueblo
  • Rocky Mountain Gastroenterology Associates
  • Danbury Clinical Research, LLC
  • Chase Medical Research, LLC
  • Consultants for Clinical Research of South Florida
  • Meridien Research
  • BioPharma Research
  • Riverside Clinical Research
  • A.G.A. Clinical Trials
  • Altus Research
  • Center for Advanced Gastroenterology
  • FIRC
  • DMI Research
  • Accord Clinical Research, LLC
  • International Clinical Research-US,LLC
  • Lakeview Medical Research
  • Venra Clinical Studies, LLC
  • Alliance Clinical Research
  • Atlanta Center for Gastroenterology
  • Tri County Research
  • Northwest Gastroenterologist S.C.
  • Illinois Center for Clinical Research
  • Southwest Gastroenterology
  • Elkhart Clinic, LLC/Indiana Medical Research, LLC
  • MediSphere Medical Research Center, LLC
  • Mercy Gastroenterology Clinic
  • Gastrointestinal Clinic of Quad Cities
  • Heartland Research Associates, LLC
  • Heartland Research Associates, LLC
  • Graves-Gilbert Clinic
  • Tri-State Gastroenterology Associates, PSC
  • Hometown Urgent Care and Research
  • The Research Group of Lexington, LLC
  • University of Louisville Medical-Dental Complex
  • Tover Health Systems Center for Clinical Research
  • Investigative Clinical Research
  • Meritus Center for Clinical Resarch
  • Spectrum Clinical Research Inc.
  • Commonwealth Clinical Studies
  • NECCR Internal Medicine and Cardiology Associates LLC
  • ActivMed Practices and Research
  • University of Michigan Health System
  • Clinical Research Institute of Michigan, LLC
  • Saginaw Valley Medical Research Group, LLC
  • Mayo Clinic
  • Gastrointestinal Accociates, PA
  • Digestive Research Specialist
  • Midwest Center for Clinical Research
  • Center for Digestive and Liver Diseases, Inc.
  • St. Louis Center for Clinical Research
  • Montana Health Research Institute, Inc.
  • Dr. Meera Dewan PC
  • Anderson & Collins Clinical Research
  • South Jersey Gastroenterology. P.A.
  • Atlantic Research Affiliates
  • Life Medi-Research
  • Long Island Clinical Research Associates, LLP
  • Long Island Gastrointestinal Research Group
  • Winthrop University Hospital Clinical Trials Center
  • Research Associates of New York
  • Premier Medical Group of the Hudson Valley
  • Gastrointestinal Research Associates, LLC
  • The UNC Center for Functional GI and Motility Disorders
  • PMG Research of Charlotte, LLC
  • LeBauer Research Associates, P.A.
  • PMG Research of Hickory, LLC
  • Peters Medical Research
  • Kinston Medical Specialist, P.A.
  • Wake Research Associates
  • Trial Management Associates LLC
  • PMG Research of Winston-Salem
  • Lillestol Research LLC
  • Akron Gastroenterology Associates
  • Gastroenterology Research Consultants of Greater Cincinnati
  • Hometown Urgent Care
  • Hometown Urgent Care
  • Hometown Urgent Care and Research
  • Hometown Urgent Care and Research
  • Physicians Research, Inc
  • Journey Clinical Research
  • Central Sooner Research
  • Oklahoma Foundation for Digestive Research
  • Lynn Health Science Institute
  • Sooner Clinical Research
  • Northwest Gastroenterology Clinic, LLC
  • Safe Harbor Clinical Research
  • Southeast Medical Research
  • SC Clinical Research, LLC
  • Coastal Carolina Research Center in Goose Creek
  • Hillcrest Clinical Research, LLC
  • Midwest Medical Care
  • Gastroenterology Associates
  • ClinSearch, LLC
  • Alpha Clinical Research
  • Memphis Gastroenterology Group
  • Associates in Gastroenterology
  • Gastroenterology Associates Clinical Research
  • Columbia Medical Group -The First Clinic, Inc.
  • Dial Research Associates, INC
  • TN Medical Research
  • Research Across America/ Family Medicine Associates of Texas
  • Corsicana Medical Research, PLLC
  • Texas University Health Sciences Center
  • Gastroenterology Consultants, P.A.
  • Houston S. Endoscopy and Research Center
  • Pioneer Research Solutions, Inc
  • Digestive Health Associates of Texas
  • Sun Research Institute
  • Clinical Trials of Texas
  • Advanced Research Institute
  • Advanced Research Institute
  • Advanced Research Institute
  • Advanced Research Institute
  • Gastroenterology, Ltd.
  • Wisconsin Center for Advanced Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment

Placebo

Arm Description

0.5 mg asimadoline bid

Placebo

Outcomes

Primary Outcome Measures

12 Week Abdominal Pain and Stool (APS) Frequency Responder
A study responder is a subject who has both a decrease from baseline of IBS-related abdominal pain and a decrease from baseline of daily bowel movements

Secondary Outcome Measures

Compare the two treatment groups with respect to IBS-related abdominal pain
Compare the two treatment groups with respect to stool frequency
Compare the two treatment groups with respect to stool urgency
Compare the two treatment groups with respect to IBS symptoms
Compare the two treatment groups with respect to stool consistency scores
Using the Bristol Stool Form Scale
Incidence of adverse events as a measure of tolerability
Abnormalities of laboratory tests as a measure of tolerability

Full Information

First Posted
April 6, 2010
Last Updated
December 17, 2013
Sponsor
Tioga Pharmaceuticals
Collaborators
RTI Health Solutions
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1. Study Identification

Unique Protocol Identification Number
NCT01100684
Brief Title
Study of Asimadoline to Treat Diarrhea-Predominant Irritable Bowel Syndrome (D-IBS)
Official Title
A 12-Week, Randomized, Double-Blind, Placebo-Controlled Study of Asimadoline in Subjects With Diarrhea-Predominant Irritable Bowel Syndrome (D-IBS)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (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 determine whether asimadoline is safe and effective at treating D-IBS.
Detailed Description
The primary objective of the study is to compare the efficacy of the two treatments with respect to improvement in IBS-related abdominal pain severity and reduction in stool frequency. During the 12-week treatment period, daily IBS-related abdominal pain severity score and daily frequency of bowel movements will be averaged over each week to determine average values for each endpoint. For each subject, weekly response to treatment will be based on the following parameters: Decrease from baseline of at least 30% in the average IBS-related daily abdominal pain severity score Decrease from baseline of at least 25% in the average number of daily bowel movements A subject must meet both criteria to be considered a weekly responder. The primary efficacy endpoint is based on an "overall study responder," defined as a subject having 6 or more weeks of weekly response to treatment out of the 12 weeks in the treatment period. Overall study responder will be stratified by timing of bowel preparation and endoscopy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea Predominant Irritable Bowel Syndrome
Keywords
diarrhea predominant irritable bowel syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
611 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
0.5 mg asimadoline bid
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Asimadoline
Other Intervention Name(s)
EMD 61 753, EMR 63 320
Intervention Description
0.5 mg Asimadoline BID
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
12 Week Abdominal Pain and Stool (APS) Frequency Responder
Description
A study responder is a subject who has both a decrease from baseline of IBS-related abdominal pain and a decrease from baseline of daily bowel movements
Time Frame
Weekly responder based on patient assessments made daily in each week of the 12-week Treatment Period to determine 12 week APS responder
Secondary Outcome Measure Information:
Title
Compare the two treatment groups with respect to IBS-related abdominal pain
Time Frame
Up to 12 weeks
Title
Compare the two treatment groups with respect to stool frequency
Time Frame
Up to 12 weeks
Title
Compare the two treatment groups with respect to stool urgency
Time Frame
Up to 12 weeks
Title
Compare the two treatment groups with respect to IBS symptoms
Time Frame
up to 12 weeks
Title
Compare the two treatment groups with respect to stool consistency scores
Description
Using the Bristol Stool Form Scale
Time Frame
Up to 12 weeks
Title
Incidence of adverse events as a measure of tolerability
Time Frame
Up to 16 weeks
Title
Abnormalities of laboratory tests as a measure of tolerability
Time Frame
Up to 16 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: Signs and dates a written informed consent form. Male and female subjects aged 18-79 who are fluent in English All subjects must use protocol specified contraceptive measures The subject is or has been diagnosed with IBS with symptom onset at least 6 months prior to diagnosis. IBS is defined as the subject having recurrent abdominal pain or discomfort at least 3 days per month in the past 3 months associated with at least two of the following symptoms: Improvement with defecation Onset associated with a change in frequency of stool Onset associated with a change in form (appearance) of stool The subject has been diagnosed with diarrhea-predominant IBS Within 2 years of the randomization visit, the subject has normal results from a flexible sigmoidoscopy, a colonoscopy, or a barium enema plus flexible sigmoidoscopy, according to the subject's age by a specified algorithm. Exclusion Criteria: The subject exhibits evidence of a biochemical or structural abnormality of the digestive tract. Subject has a concurrent illness or disability (excluding IBS) that may affect the interpretation of clinical efficacy and/or safety data or otherwise contraindicates participation in this clinical study (e.g., an unstable cardiovascular, renal, hepatic, pulmonary, endocrine, metabolic, GI, hematological, or neurological condition). The subject has a family history of prolonged QT syndrome. The subject has been diagnosed with a major psychiatric disorder. The subject has a history of alcohol or substance abuse within the past 2 years. The subject has a history or current evidence of laxative abuse The subject has a positive stool sample for ova or parasite. The subject has used an investigational drug or participated in an investigational study within 30 days of screening. The subject refuses to discontinue one (or more) prohibited medications at least 7 days prior to the screening visit. The subject refuses to maintain a stable dose of one (or more) allowable concurrent medications for at least 30 days prior to the screening visit. The subject is a pregnant woman or a woman who is breast feeding. The subject is unable or unwilling to follow directions or use the electronic diary system.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allen Mangel, M.D.Ph.D.
Organizational Affiliation
CMO
Official's Role
Study Chair
Facility Information:
Facility Name
North Alabama Research Center, LLC
City
Athens
State/Province
Alabama
ZIP/Postal Code
35611
Country
United States
Facility Name
Alliance Clinical Research
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35213
Country
United States
Facility Name
Medical Affliated Research Center, Inc.
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Saadat Ansari MD LLC
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Connect Clinical Research Center
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Digestive Health Research Unit
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85260
Country
United States
Facility Name
Adobe Clinical Research, LLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
ACRC/Arizona Clinical Research Center, Inc.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Facility Name
Genova Clinical Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
W/C Clinical Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
Lynn Institute of the Ozarks
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Applied Research Center of Arkansas
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72212
Country
United States
Facility Name
Arkansas Gastroenterology
City
Sherwood
State/Province
Arkansas
ZIP/Postal Code
72120
Country
United States
Facility Name
Providence Clinical Research
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
GW Research Inc,
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Facility Name
La Jolla Clinical Research, Inc
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
Discovery Clinical Research
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Digestive & Liver Disease Specialist
City
Garden Grove
State/Province
California
ZIP/Postal Code
92840
Country
United States
Facility Name
Collaborative Neuroscience Network Inc
City
Long Beach
State/Province
California
ZIP/Postal Code
90808
Country
United States
Facility Name
California Gastroenterology Associates
City
Madera
State/Province
California
ZIP/Postal Code
93637
Country
United States
Facility Name
Community Clinical Trials
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Sutter Medical Group Gastroenterology
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Medical Center for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Medical Associates Research Group, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Westlake Medical Research
City
Westlake Village
State/Province
California
ZIP/Postal Code
91361
Country
United States
Facility Name
Lynne Institute of the Rockies
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Arapahoe Gastroenterology
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
Lynn Institute of Pueblo
City
Pueblo
State/Province
Colorado
ZIP/Postal Code
81008
Country
United States
Facility Name
Rocky Mountain Gastroenterology Associates
City
Thornton
State/Province
Colorado
ZIP/Postal Code
80229
Country
United States
Facility Name
Danbury Clinical Research, LLC
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Chase Medical Research, LLC
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Consultants for Clinical Research of South Florida
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
Facility Name
Meridien Research
City
Brookville
State/Province
Florida
ZIP/Postal Code
34601
Country
United States
Facility Name
BioPharma Research
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Riverside Clinical Research
City
Edgewater
State/Province
Florida
ZIP/Postal Code
32132
Country
United States
Facility Name
A.G.A. Clinical Trials
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Altus Research
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
Facility Name
Center for Advanced Gastroenterology
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
FIRC
City
Miami
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
DMI Research
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33782
Country
United States
Facility Name
Accord Clinical Research, LLC
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32129
Country
United States
Facility Name
International Clinical Research-US,LLC
City
Sanford
State/Province
Florida
ZIP/Postal Code
32771
Country
United States
Facility Name
Lakeview Medical Research
City
Summerfield
State/Province
Florida
ZIP/Postal Code
34491
Country
United States
Facility Name
Venra Clinical Studies, LLC
City
Wellington
State/Province
Florida
ZIP/Postal Code
33414
Country
United States
Facility Name
Alliance Clinical Research
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32792
Country
United States
Facility Name
Atlanta Center for Gastroenterology
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Tri County Research
City
Hartwell
State/Province
Georgia
ZIP/Postal Code
30643
Country
United States
Facility Name
Northwest Gastroenterologist 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
Southwest Gastroenterology
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
Elkhart Clinic, LLC/Indiana Medical Research, LLC
City
Elkhart
State/Province
Indiana
ZIP/Postal Code
46514
Country
United States
Facility Name
MediSphere Medical Research Center, LLC
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Mercy Gastroenterology Clinic
City
Clive
State/Province
Iowa
ZIP/Postal Code
50325
Country
United States
Facility Name
Gastrointestinal Clinic of Quad Cities
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52807
Country
United States
Facility Name
Heartland Research Associates, LLC
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Facility Name
Heartland Research Associates, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Graves-Gilbert Clinic
City
Bowling Green
State/Province
Kentucky
ZIP/Postal Code
42101
Country
United States
Facility Name
Tri-State Gastroenterology Associates, PSC
City
Crestview Hills
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
Hometown Urgent Care and Research
City
Hebron
State/Province
Kentucky
ZIP/Postal Code
41048
Country
United States
Facility Name
The Research Group of Lexington, LLC
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Facility Name
University of Louisville Medical-Dental Complex
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Tover Health Systems Center for Clinical Research
City
Madisonville
State/Province
Kentucky
ZIP/Postal Code
42431
Country
United States
Facility Name
Investigative Clinical Research
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Meritus Center for Clinical Resarch
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21742
Country
United States
Facility Name
Spectrum Clinical Research Inc.
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Commonwealth Clinical Studies
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02302
Country
United States
Facility Name
NECCR Internal Medicine and Cardiology Associates LLC
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720
Country
United States
Facility Name
ActivMed Practices and Research
City
Haverhill
State/Province
Massachusetts
ZIP/Postal Code
01830
Country
United States
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48009
Country
United States
Facility Name
Clinical Research Institute of Michigan, LLC
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Facility Name
Saginaw Valley Medical Research Group, LLC
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48604
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Gastrointestinal Accociates, PA
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
Digestive Research Specialist
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
Midwest Center for Clinical Research
City
Lees Summit
State/Province
Missouri
ZIP/Postal Code
64064
Country
United States
Facility Name
Center for Digestive and Liver Diseases, Inc.
City
Mexico
State/Province
Missouri
ZIP/Postal Code
65265
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, Inc.
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
Dr. Meera Dewan PC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Anderson & Collins Clinical Research
City
Edison
State/Province
New Jersey
ZIP/Postal Code
08817
Country
United States
Facility Name
South Jersey Gastroenterology. P.A.
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Facility Name
Atlantic Research Affiliates
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Life Medi-Research
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11206
Country
United States
Facility Name
Long Island Clinical Research Associates, LLP
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Long Island Gastrointestinal Research Group
City
Great Neck
State/Province
New York
ZIP/Postal Code
11023
Country
United States
Facility Name
Winthrop University Hospital Clinical Trials Center
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Research Associates of New York
City
New York,
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
Premier Medical Group of the Hudson Valley
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
Gastrointestinal Research Associates, LLC
City
Setauket
State/Province
New York
ZIP/Postal Code
11733
Country
United States
Facility Name
The UNC Center for Functional GI and Motility Disorders
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
PMG Research of Charlotte, LLC
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
LeBauer Research Associates, P.A.
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Facility Name
PMG Research of Hickory, LLC
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28602
Country
United States
Facility Name
Peters Medical Research
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Kinston Medical Specialist, P.A.
City
Kinston
State/Province
North Carolina
ZIP/Postal Code
28501
Country
United States
Facility Name
Wake Research Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27616
Country
United States
Facility Name
Trial Management Associates LLC
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28403
Country
United States
Facility Name
PMG Research of Winston-Salem
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Lillestol Research LLC
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Akron Gastroenterology Associates
City
Akron
State/Province
Ohio
ZIP/Postal Code
44302
Country
United States
Facility Name
Gastroenterology Research Consultants of Greater Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Hometown Urgent Care
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Hometown Urgent Care
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45432
Country
United States
Facility Name
Hometown Urgent Care and Research
City
Groveport
State/Province
Ohio
ZIP/Postal Code
43125
Country
United States
Facility Name
Hometown Urgent Care and Research
City
Miamisburg
State/Province
Ohio
ZIP/Postal Code
45342
Country
United States
Facility Name
Physicians Research, Inc
City
Zanesville
State/Province
Ohio
ZIP/Postal Code
43701
Country
United States
Facility Name
Journey Clinical Research
City
Duncan
State/Province
Oklahoma
ZIP/Postal Code
73533
Country
United States
Facility Name
Central Sooner Research
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73071
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
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Sooner Clinical Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Northwest Gastroenterology Clinic, LLC
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Safe Harbor Clinical Research
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02914
Country
United States
Facility Name
Southeast Medical Research
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
SC Clinical Research, LLC
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
Coastal Carolina Research Center in Goose Creek
City
Goose Creek
State/Province
South Carolina
ZIP/Postal Code
29445
Country
United States
Facility Name
Hillcrest Clinical Research, LLC
City
Simpsonville
State/Province
South Carolina
ZIP/Postal Code
29681
Country
United States
Facility Name
Midwest Medical Care
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57108
Country
United States
Facility Name
Gastroenterology Associates
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
ClinSearch, LLC
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Alpha Clinical Research
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
Associates in Gastroenterology
City
Hermitage
State/Province
Tennessee
ZIP/Postal Code
37076
Country
United States
Facility Name
Gastroenterology Associates Clinical Research
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Columbia Medical Group -The First Clinic, Inc.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Dial Research Associates, INC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
TN Medical Research
City
Spring Hill
State/Province
Tennessee
ZIP/Postal Code
37147
Country
United States
Facility Name
Research Across America/ Family Medicine Associates of Texas
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75010
Country
United States
Facility Name
Corsicana Medical Research, PLLC
City
Corsicana
State/Province
Texas
ZIP/Postal Code
75110
Country
United States
Facility Name
Texas University Health Sciences Center
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
Country
United States
Facility Name
Gastroenterology Consultants, P.A.
City
Houston
State/Province
Texas
ZIP/Postal Code
77034
Country
United States
Facility Name
Houston S. Endoscopy and Research Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77079
Country
United States
Facility Name
Pioneer Research Solutions, Inc
City
Houston
State/Province
Texas
ZIP/Postal Code
77098
Country
United States
Facility Name
Digestive Health Associates of Texas
City
Plano
State/Province
Texas
ZIP/Postal Code
75075
Country
United States
Facility Name
Sun Research Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Clinical Trials of Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Advanced Research Institute
City
Clinton
State/Province
Utah
ZIP/Postal Code
84015
Country
United States
Facility Name
Advanced Research Institute
City
Logan
State/Province
Utah
ZIP/Postal Code
84341
Country
United States
Facility Name
Advanced Research Institute
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
Advanced Research Institute
City
Sandy
State/Province
Utah
ZIP/Postal Code
84094
Country
United States
Facility Name
Gastroenterology, Ltd.
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23454
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

Study of Asimadoline to Treat Diarrhea-Predominant Irritable Bowel Syndrome (D-IBS)

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