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An Open-Label, Long-Term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation

Primary Purpose

Chronic Constipation, Irritable Bowel Syndrome With Constipation

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Linaclotide
Sponsored by
Forest Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Constipation focused on measuring Constipation, Chronic Constipation, Irritable Bowel Syndrome With Constipation, Linaclotide

Eligibility Criteria

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

Inclusion Criteria:

  • Patients must have

    • entered study LIN-MD 01[NCT00765882] or LIN-MD-31 [NCT00948818] and at minimum completed the pre-treatment period or
    • completed one of the following studies: MCP-103-004 [NCT00306748], MCP-103-005 [NCT00258193], MCP-103-201 [NCT00402337], MCP-103-202 [NCT00460811]
  • Sexually active patients of childbearing potential agree to use birth control
  • Females of childbearing potential must have a negative urine pregnancy test prior to dosing
  • Lactating females must agree not to breastfeed
  • Patient must meet protocol criteria for CC or IBS-C

Exclusion Criteria:

  • Patient must not use protocol-defined prohibited medicine
  • Patient is planning to receive an investigational drug at any time during the study
  • Patient has an unresolved AE or a clinically significant finding on a physical examination, 12-lead ECG, or clinical laboratory test

Sites / Locations

  • Innovative Clinical Trials
  • Parkway Medical Center
  • Medical Affiliated Research Center, Inc.
  • Radiant Research, Inc.
  • Pivotal Research Centers
  • Pivotal Research Center
  • Carl T Hayden VA Medical Center GI Section-CS-111G
  • Elite Clinical Studies, LLC
  • Radiant Research, Inc.
  • Genova Clinical Research, Inc.
  • Adobe Clinical Research, LLC
  • Providence Clinical Research
  • Encompass Clinical Research North Coast
  • Family Medical Center
  • Axis Clinical Trials
  • Facey Medical Foundation
  • Advanced Clinical Research Institute
  • Westlake Medical Research
  • Boulder Medical Center, P.C.
  • Lynn Institute of the Rockies
  • Colorado Gastroenterology, Prof LLC
  • Longmont Medical Research Network
  • Western States Clinical Research
  • Chase Medical Research, LLC
  • Clinical Trials Management of Boca Raton, Inc.
  • Meridien Research
  • PAB Clinical Research
  • Meridien Research
  • Clinical Physiology Associates Clinical Study Center
  • Jupiter Research, Inc.
  • FPA Clinical Research
  • Pharmax Research Clinic
  • United Medical Research
  • RenStar Medical Research
  • Compass Research
  • Emerald Coast Research Associates
  • University Clinical Research, Inc.
  • Meridien Research
  • Miami Research Associates
  • Meridien Research
  • Advanced Research Institute
  • Florida Medical Clinic, P.A. Clinical Research Division
  • Radiant Research, Inc.
  • Gastrointestinal Specialists of Georgia, PC
  • Atlanta Gastroenterology Associates, LLC
  • Clinical Research Atlanta
  • North Georgia Clinical Research
  • Rosemark WomenCare Specialist
  • Rockford Gastroenterology Associates, Ltd.
  • MediSphere Medical Research Center, LLC
  • University of Iowa Hospitals & Clinics
  • Heartland Research Associates, LLC
  • Heartland Research Associates, LLC
  • Heartland Research Associates, LLC
  • Heartland Research Associates, LLC
  • Central Kentucky Research Associates
  • Trover Health System
  • Medical Development Centers, LLC
  • Clinical Trials of America, Inc.
  • Metropolitan Gastroenterology Group PC, Chevy Chase Clinical Research
  • Meritus Center for Clinical Research
  • Charm City Research
  • Boston Clinical Trials
  • Kalamazoo Gastroenterology Hepatology
  • Ridgeview Research Two Twelve Medical Center
  • St. Louis Center for Clinical Research
  • The Gastroenterology Group of S.J.
  • New Mexico Clinical Research and Osteoporosis Center
  • Lifeline Research Institute
  • Long Island Clinical Research Associates, LLP
  • Long Island Gastrointestinal Research Group
  • Gastrointestinal Research Associates, LLC
  • MediSpect, LLC
  • Cumberland Research Associates, LLC
  • LeBauer Research Associates, P.A.
  • Clinical Trials of America, INC
  • Wake Research Associates, LLC
  • Hanover Medical Specialists, PA
  • Digestive Health Specialists, PA
  • Consultants for Clinical Research
  • Rapid Medical Research, Inc.
  • Remington Davis
  • Hometown Urgent Care and Research
  • Oklahoma Foundation for Digestive Research
  • Gastroenterology United of Tulsa
  • Clinical Trials Research Services, LLC
  • Upstate Pharmaceutical Research
  • Mountain View Clinical Research
  • Radiant Research
  • Nashville Medical Research Institute
  • Professional Quality Research, Inc.
  • Research Across America RHD Professional Plaza IV
  • Houston Digestive Diseases Clinic
  • Houston Medical Research Associates
  • R/D Clinical Research, Inc.
  • Quality Research Inc.
  • Diagnostics Research Group
  • Fatigue Consultation Clinic
  • Department of Gastroenterology University of Utah Hospital
  • Department of Veterans Affairs Research Department
  • Charlottesville Medical Research
  • New River Valley Research Institute
  • Health Research of Hampton Roads
  • National Clinical Research - Norfolk, Inc.
  • Clinical Research Associates of Tidewater
  • National Clinical Research-Richmond, Inc.
  • Northwest Gastroenterology Associates
  • Radiant Research, Inc.
  • Wenatchee Valley Medical Center Clinical Research Dept.
  • Aurora Advanced Healthcare, Inc. Clinical Research Center
  • GI Research Institute
  • St. Joseph Healthcare
  • MedPhase Canada
  • Meadowlands Family Health Center
  • London Road Diagnostic Clinic and Medical Center
  • Medicor Research, Inc.
  • PrimeHealth Clinical Research
  • Toronto Digestive Disease Associates, Inc.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Linaclotide

Arm Description

Linaclotide 290 μg/day capsules, administered orally once daily for up to 78 weeks in participants with either CC or IBS-C. Dose reduction to 145 μg/day was permitted at the discretion of the Investigator if a participant experienced AEs intolerable enough to prompt consideration of study withdrawal. After a temporary suspension of dosing, participants may have received either 145 μg/day or 290 μg/day of linaclotide, at the discretion of the Investigator. Subsequent dose adjustments (increases or decreases between 290 μg/day and 145 μg/day) were permitted also at the Investigator's discretion.

Outcomes

Primary Outcome Measures

Number of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs)
An AE is any untoward medical occurrence in a clinical study participant administered study drug. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not related to the medicinal product. An AE that occurred during the treatment period was defined as a TEAE if the AE was either not present at, or before, the day of the first dose of open-label study medication in this study or was present at, or before, the day of the first dose of open-label study medication in this study and increased in severity during the treatment period. AEs included abnormal clinically significant findings for clinical laboratory tests, physical examination findings, vital sign measurements and electrocardiograms (ECGs).

Secondary Outcome Measures

Full Information

First Posted
October 1, 2008
Last Updated
January 24, 2019
Sponsor
Forest Laboratories
Collaborators
Ironwood Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00765999
Brief Title
An Open-Label, Long-Term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation
Official Title
An Open-Label, Long-Term Safety Study of Oral Linaclotide Administered to Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
October 31, 2008 (Actual)
Primary Completion Date
January 31, 2012 (Actual)
Study Completion Date
January 31, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Forest Laboratories
Collaborators
Ironwood Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study is to assess the long-term safety of linaclotide administered to patients with chronic constipation (CC) or irritable bowel syndrome with constipation (IBS-C).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Constipation, Irritable Bowel Syndrome With Constipation
Keywords
Constipation, Chronic Constipation, Irritable Bowel Syndrome With Constipation, Linaclotide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1559 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Linaclotide
Arm Type
Experimental
Arm Description
Linaclotide 290 μg/day capsules, administered orally once daily for up to 78 weeks in participants with either CC or IBS-C. Dose reduction to 145 μg/day was permitted at the discretion of the Investigator if a participant experienced AEs intolerable enough to prompt consideration of study withdrawal. After a temporary suspension of dosing, participants may have received either 145 μg/day or 290 μg/day of linaclotide, at the discretion of the Investigator. Subsequent dose adjustments (increases or decreases between 290 μg/day and 145 μg/day) were permitted also at the Investigator's discretion.
Intervention Type
Drug
Intervention Name(s)
Linaclotide
Other Intervention Name(s)
Linzess
Intervention Description
Linaclotide capsules, oral, once daily each morning at least 30 minutes before breakfast for the duration of the study.
Primary Outcome Measure Information:
Title
Number of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs)
Description
An AE is any untoward medical occurrence in a clinical study participant administered study drug. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not related to the medicinal product. An AE that occurred during the treatment period was defined as a TEAE if the AE was either not present at, or before, the day of the first dose of open-label study medication in this study or was present at, or before, the day of the first dose of open-label study medication in this study and increased in severity during the treatment period. AEs included abnormal clinically significant findings for clinical laboratory tests, physical examination findings, vital sign measurements and electrocardiograms (ECGs).
Time Frame
Up to 78 weeks for AEs; within 30 days of last dose of study drug (up to 82 weeks) for serious AEs.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must have entered study LIN-MD 01[NCT00765882] or LIN-MD-31 [NCT00948818] and at minimum completed the pre-treatment period or completed one of the following studies: MCP-103-004 [NCT00306748], MCP-103-005 [NCT00258193], MCP-103-201 [NCT00402337], MCP-103-202 [NCT00460811] Sexually active patients of childbearing potential agree to use birth control Females of childbearing potential must have a negative urine pregnancy test prior to dosing Lactating females must agree not to breastfeed Patient must meet protocol criteria for CC or IBS-C Exclusion Criteria: Patient must not use protocol-defined prohibited medicine Patient is planning to receive an investigational drug at any time during the study Patient has an unresolved AE or a clinically significant finding on a physical examination, 12-lead ECG, or clinical laboratory test
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Eng, PhD
Organizational Affiliation
Forest Laboratories
Official's Role
Study Director
Facility Information:
Facility Name
Innovative Clinical Trials
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Parkway Medical Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35215
Country
United States
Facility Name
Medical Affiliated Research Center, Inc.
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Radiant Research, Inc.
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Pivotal Research Centers
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Pivotal Research Center
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Carl T Hayden VA Medical Center GI Section-CS-111G
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Elite Clinical Studies, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Radiant Research, Inc.
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
Genova Clinical Research, Inc.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Adobe Clinical Research, LLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Providence Clinical Research
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
Encompass Clinical Research North Coast
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Family Medical Center
City
Foothill Ranch
State/Province
California
ZIP/Postal Code
92610
Country
United States
Facility Name
Axis Clinical Trials
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Facey Medical Foundation
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
Advanced Clinical Research Institute
City
Orange
State/Province
California
ZIP/Postal Code
92869
Country
United States
Facility Name
Westlake Medical Research
City
Westlake Village
State/Province
California
ZIP/Postal Code
91361
Country
United States
Facility Name
Boulder Medical Center, P.C.
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80304
Country
United States
Facility Name
Lynn Institute of the Rockies
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Colorado Gastroenterology, Prof LLC
City
Denver
State/Province
Colorado
ZIP/Postal Code
80205
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
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Chase Medical Research, LLC
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Clinical Trials Management of Boca Raton, Inc.
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33428
Country
United States
Facility Name
Meridien Research
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
Country
United States
Facility Name
PAB Clinical Research
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Meridien Research
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34601
Country
United States
Facility Name
Clinical Physiology Associates Clinical Study Center
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
Facility Name
Jupiter Research, Inc.
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
FPA Clinical Research
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
Pharmax Research Clinic
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
United Medical Research
City
New Smyrna Beach
State/Province
Florida
ZIP/Postal Code
32168
Country
United States
Facility Name
RenStar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Compass Research
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Emerald Coast Research Associates
City
Panama City
State/Province
Florida
ZIP/Postal Code
32405
Country
United States
Facility Name
University Clinical Research, Inc.
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Meridien Research
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
Miami Research Associates
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Meridien Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Advanced Research Institute
City
Trinity
State/Province
Florida
ZIP/Postal Code
34655
Country
United States
Facility Name
Florida Medical Clinic, P.A. Clinical Research Division
City
Zephyrhills
State/Province
Florida
ZIP/Postal Code
33542
Country
United States
Facility Name
Radiant Research, Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Gastrointestinal Specialists of Georgia, PC
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Atlanta Gastroenterology Associates, LLC
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30067
Country
United States
Facility Name
Clinical Research Atlanta
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
North Georgia Clinical Research
City
Woodstock
State/Province
Georgia
ZIP/Postal Code
30189
Country
United States
Facility Name
Rosemark WomenCare Specialist
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Rockford Gastroenterology Associates, Ltd.
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61107
Country
United States
Facility Name
MediSphere Medical Research Center, LLC
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
University of Iowa Hospitals & Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Heartland Research Associates, LLC
City
Arkansas City
State/Province
Kansas
ZIP/Postal Code
67005
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
67205
Country
United States
Facility Name
Heartland Research Associates, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Central Kentucky Research Associates
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Trover Health System
City
Madisonville
State/Province
Kentucky
ZIP/Postal Code
42431
Country
United States
Facility Name
Medical Development Centers, LLC
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Clinical Trials of America, Inc.
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
Metropolitan Gastroenterology Group PC, Chevy Chase Clinical Research
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Meritus Center for Clinical Research
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21742
Country
United States
Facility Name
Charm City Research
City
Towson
State/Province
Maryland
ZIP/Postal Code
21286
Country
United States
Facility Name
Boston Clinical Trials
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Kalamazoo Gastroenterology Hepatology
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49048
Country
United States
Facility Name
Ridgeview Research Two Twelve Medical Center
City
Chaska
State/Province
Minnesota
ZIP/Postal Code
55318
Country
United States
Facility Name
St. Louis Center for Clinical Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
The Gastroenterology Group of S.J.
City
Vineland
State/Province
New Jersey
ZIP/Postal Code
08360
Country
United States
Facility Name
New Mexico Clinical Research and Osteoporosis Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Lifeline Research Institute
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11214
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
Gastrointestinal Research Associates, LLC
City
Setauket
State/Province
New York
ZIP/Postal Code
11733
Country
United States
Facility Name
MediSpect, LLC
City
Boone
State/Province
North Carolina
ZIP/Postal Code
28607
Country
United States
Facility Name
Cumberland Research Associates, LLC
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
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
Clinical Trials of America, INC
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
Wake Research Associates, LLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Hanover Medical Specialists, PA
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Digestive Health Specialists, PA
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Consultants for Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Rapid Medical Research, Inc.
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Remington Davis
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Hometown Urgent Care and Research
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45432
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
Gastroenterology United of Tulsa
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74135
Country
United States
Facility Name
Clinical Trials Research Services, LLC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15206
Country
United States
Facility Name
Upstate Pharmaceutical Research
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Mountain View Clinical Research
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Radiant Research
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Nashville Medical Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Professional Quality Research, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Research Across America RHD Professional Plaza IV
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
Houston Digestive Diseases Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Houston Medical Research Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
R/D Clinical Research, Inc.
City
Lake Jackson
State/Province
Texas
ZIP/Postal Code
77566
Country
United States
Facility Name
Quality Research Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Facility Name
Diagnostics Research Group
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Fatigue Consultation Clinic
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84102
Country
United States
Facility Name
Department of Gastroenterology University of Utah Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Department of Veterans Affairs Research Department
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84148
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
Health Research of Hampton Roads
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
National Clinical Research - Norfolk, Inc.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Clinical Research Associates of Tidewater
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
National Clinical Research-Richmond, Inc.
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
Northwest Gastroenterology Associates
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
Radiant Research, Inc.
City
Lakewood
State/Province
Washington
ZIP/Postal Code
98499
Country
United States
Facility Name
Wenatchee Valley Medical Center Clinical Research Dept.
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States
Facility Name
Aurora Advanced Healthcare, Inc. Clinical Research Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209
Country
United States
Facility Name
GI Research Institute
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2K5
Country
Canada
Facility Name
St. Joseph Healthcare
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
MedPhase Canada
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 8E4
Country
Canada
Facility Name
Meadowlands Family Health Center
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K2C 3R2
Country
Canada
Facility Name
London Road Diagnostic Clinic and Medical Center
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 4X3
Country
Canada
Facility Name
Medicor Research, Inc.
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 1H5
Country
Canada
Facility Name
PrimeHealth Clinical Research
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4S 1Y2
Country
Canada
Facility Name
Toronto Digestive Disease Associates, Inc.
City
Vaughan
State/Province
Ontario
ZIP/Postal Code
L4L 4Y7
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

An Open-Label, Long-Term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation

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