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Chronic ConstipationPhase 3NCT00765999

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

A Phase 3 study testing Linaclotide in people with Chronic Constipation and Irritable Bowel Syndrome With Constipation, run by Forest Laboratories at 118 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Linaclotide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,559 participants
Where
118 sitesin 2 countries
Study dates
31 Oct 2008to 31 Jan 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

118 sites in 2 countries.

118 sites in 2 countries

United States110 sites

  • New Mexico Clinical Research and Osteoporosis Center

    Albuquerque, New Mexico, 87106

  • Heartland Research Associates, LLC

    Arkansas City, Kansas, 67005

  • Radiant Research, Inc.

    Atlanta, Georgia, 30342

  • Professional Quality Research, Inc.

    Austin, Texas, 78705

  • Medical Development Centers, LLC

    Baton Rouge, Louisiana, 70808

  • Northwest Gastroenterology Associates

    Bellevue, Washington, 98004

  • Innovative Clinical Trials

    Birmingham, Alabama, 35205

  • Parkway Medical Center

    Birmingham, Alabama, 35215

  • Clinical Trials Management of Boca Raton, Inc.

    Boca Raton, Florida, 33428

  • MediSpect, LLC

    Boone, North Carolina, 28607

  • Boston Clinical Trials

    Boston, Massachusetts, 02135

  • Boulder Medical Center, P.C.

    Boulder, Colorado, 80304

  • Meridien Research

    Bradenton, Florida, 34208

  • PAB Clinical Research

    Brandon, Florida, 33511

  • Lifeline Research Institute

    Brooklyn, New York, 11214

  • Meridien Research

    Brooksville, Florida, 34601

  • Providence Clinical Research

    Burbank, California, 91505

  • Radiant Research, Inc.

    Chandler, Arizona, 85224

  • Charlottesville Medical Research

    Charlottesville, Virginia, 22911

  • Ridgeview Research Two Twelve Medical Center

    Chaska, Minnesota, 55318

  • Metropolitan Gastroenterology Group PC, Chevy Chase Clinical Research

    Chevy Chase, Maryland, 20815

  • New River Valley Research Institute

    Christiansburg, Virginia, 24073

  • Consultants for Clinical Research

    Cincinnati, Ohio, 45219

  • Rapid Medical Research, Inc.

    Cleveland, Ohio, 44122

  • Lynn Institute of the Rockies

    Colorado Springs, Colorado, 80907

  • Remington Davis

    Columbus, Ohio, 43215

  • Research Across America RHD Professional Plaza IV

    Dallas, Texas, 75234

  • Hometown Urgent Care and Research

    Dayton, Ohio, 45432

  • Colorado Gastroenterology, Prof LLC

    Denver, Colorado, 80205

  • Encompass Clinical Research North Coast

    Encinitas, California, 92024

  • MediSphere Medical Research Center, LLC

    Evansville, Indiana, 47714

  • Cumberland Research Associates, LLC

    Fayetteville, North Carolina, 28304

  • Family Medical Center

    Foothill Ranch, California, 92610

  • Clinical Physiology Associates Clinical Study Center

    Fort Myers, Florida, 33916

  • Long Island Clinical Research Associates, LLP

    Great Neck, New York, 11021

  • Long Island Gastrointestinal Research Group

    Great Neck, New York, 11023

  • LeBauer Research Associates, P.A.

    Greensboro, North Carolina, 27403

  • Upstate Pharmaceutical Research

    Greenville, South Carolina, 29615

  • Mountain View Clinical Research

    Greer, South Carolina, 29651

  • Radiant Research

    Greer, South Carolina, 29651

  • Meritus Center for Clinical Research

    Hagerstown, Maryland, 21742

  • Clinical Trials of America, INC

    Hickory, North Carolina, 28601

  • Houston Digestive Diseases Clinic

    Houston, Texas, 77090

  • Houston Medical Research Associates

    Houston, Texas, 77090

  • Medical Affiliated Research Center, Inc.

    Huntsville, Alabama, 35801

  • Rosemark WomenCare Specialist

    Idaho Falls, Idaho, 83404

  • University of Iowa Hospitals & Clinics

    Iowa City, Iowa, 52242

  • Jupiter Research, Inc.

    Jupiter, Florida, 33458

  • Kalamazoo Gastroenterology Hepatology

    Kalamazoo, Michigan, 49048

  • FPA Clinical Research

    Kissimmee, Florida, 34741

  • R/D Clinical Research, Inc.

    Lake Jackson, Texas, 77566

  • Radiant Research, Inc.

    Lakewood, Washington, 98499

  • Central Kentucky Research Associates

    Lexington, Kentucky, 40509

  • Longmont Medical Research Network

    Longmont, Colorado, 80501

  • Axis Clinical Trials

    Los Angeles, California, 90036

  • Trover Health System

    Madisonville, Kentucky, 42431

  • Gastrointestinal Specialists of Georgia, PC

    Marietta, Georgia, 30060

  • Atlanta Gastroenterology Associates, LLC

    Marietta, Georgia, 30067

  • Pharmax Research Clinic

    Miami, Florida, 33126

  • Aurora Advanced Healthcare, Inc. Clinical Research Center

    Milwaukee, Wisconsin, 53209

  • Facey Medical Foundation

    Mission Hills, California, 91345

  • Nashville Medical Research Institute

    Nashville, Tennessee, 37205

  • United Medical Research

    New Smyrna Beach, Florida, 32168

  • Health Research of Hampton Roads

    Newport News, Virginia, 23606

  • Heartland Research Associates, LLC

    Newton, Kansas, 67114

  • National Clinical Research - Norfolk, Inc.

    Norfolk, Virginia, 23502

  • Clinical Research Associates of Tidewater

    Norfolk, Virginia, 23507

  • RenStar Medical Research

    Ocala, Florida, 34471

  • Oklahoma Foundation for Digestive Research

    Oklahoma City, Oklahoma, 73104

  • Advanced Clinical Research Institute

    Orange, California, 92869

  • Compass Research

    Orlando, Florida, 32806

  • Emerald Coast Research Associates

    Panama City, Florida, 32405

  • University Clinical Research, Inc.

    Pembroke Pines, Florida, 33024

  • Pivotal Research Centers

    Peoria, Arizona, 85381

  • Pivotal Research Center

    Peoria, Arizona, 85381

  • Carl T Hayden VA Medical Center GI Section-CS-111G

    Phoenix, Arizona, 85012

  • Elite Clinical Studies, LLC

    Phoenix, Arizona, 85018

  • Clinical Trials Research Services, LLC

    Pittsburgh, Pennsylvania, 15206

  • Wake Research Associates, LLC

    Raleigh, North Carolina, 27612

  • National Clinical Research-Richmond, Inc.

    Richmond, Virginia, 23294

  • Rockford Gastroenterology Associates, Ltd.

    Rockford, Illinois, 61107

  • Fatigue Consultation Clinic

    Salt Lake City, Utah, 84102

  • Department of Gastroenterology University of Utah Hospital

    Salt Lake City, Utah, 84132

  • Department of Veterans Affairs Research Department

    Salt Lake City, Utah, 84148

  • Quality Research Inc.

    San Antonio, Texas, 78209

  • Diagnostics Research Group

    San Antonio, Texas, 78229

  • Radiant Research, Inc.

    Scottsdale, Arizona, 85251

  • Gastrointestinal Research Associates, LLC

    Setauket, New York, 11733

  • Clinical Trials of America, Inc.

    Shreveport, Louisiana, 71101

  • Miami Research Associates

    South Miami, Florida, 33143

  • St. Louis Center for Clinical Research

    St Louis, Missouri, 63128

  • Meridien Research

    St. Petersburg, Florida, 33709

  • Clinical Research Atlanta

    Stockbridge, Georgia, 30281

  • Meridien Research

    Tampa, Florida, 33606

  • Charm City Research

    Towson, Maryland, 21286

  • Advanced Research Institute

    Trinity, Florida, 34655

  • Genova Clinical Research, Inc.

    Tucson, Arizona, 85704

  • Adobe Clinical Research, LLC

    Tucson, Arizona, 85712

  • Gastroenterology United of Tulsa

    Tulsa, Oklahoma, 74135

  • The Gastroenterology Group of S.J.

    Vineland, New Jersey, 08360

  • Chase Medical Research, LLC

    Waterbury, Connecticut, 06708

  • Wenatchee Valley Medical Center Clinical Research Dept.

    Wenatchee, Washington, 98801

  • Westlake Medical Research

    Westlake Village, California, 91361

  • Western States Clinical Research

    Wheat Ridge, Colorado, 80033

  • Heartland Research Associates, LLC

    Wichita, Kansas, 67205

  • Heartland Research Associates, LLC

    Wichita, Kansas, 67207

  • Hanover Medical Specialists, PA

    Wilmington, North Carolina, 28401

  • Digestive Health Specialists, PA

    Winston-Salem, North Carolina, 27103

  • North Georgia Clinical Research

    Woodstock, Georgia, 30189

  • Florida Medical Clinic, P.A. Clinical Research Division

    Zephyrhills, Florida, 33542

Other trials in United States

Canada8 sites

  • Medicor Research, Inc.

    Greater Sudbury, Ontario, P3E 1H5

  • St. Joseph Healthcare

    Hamilton, Ontario, L8N 4A6

  • MedPhase Canada

    Newmarket, Ontario, L3Y 8E4

  • Meadowlands Family Health Center

    Ottawa, Ontario, K2C 3R2

  • London Road Diagnostic Clinic and Medical Center

    Sarnia, Ontario, N7T 4X3

  • PrimeHealth Clinical Research

    Toronto, Ontario, M4S 1Y2

  • GI Research Institute

    Vancouver, British Columbia, V6Z 2K5

  • Toronto Digestive Disease Associates, Inc.

    Vaughan, Ontario, L4L 4Y7

Other trials in Canada

About this study

Official title: An Open-Label, Long-Term Safety Study of Oral Linaclotide Administered to Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation

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).

Being tested
Linaclotide
Keywords
Constipation, Chronic Constipation, Irritable Bowel Syndrome With Constipation, Linaclotide
Medical subject headings
Constipation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LinaclotideDrug

    Also called Linzess

    Linaclotide capsules, oral, once daily each morning at least 30 minutes before breakfast for the duration of the study.

Study groups in NCT00765999
Study groupRoleWhat they receive
LinaclotideExperimentalLinaclotide 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.
Receives: Drug: Linaclotide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Up to 78 weeks for AEs; within 30 days of last dose of study drug (up to 82 weeks) for serious AEs.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2008 (estimated)
  2. Study start31 Oct 2008
  3. Primary completion31 Jan 2012
  4. Study completion31 Jan 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,559 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00765999
Sponsor's protocol ID
LIN-MD-02
Status last verified
Jan 2019
First submitted
1 Oct 2008
Last updated
15 Feb 2019
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Linaclotide in people with Chronic Constipation and Irritable Bowel Syndrome With Constipation, run by Forest Laboratories at 118 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 118 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs) (time frame: Up to 78 weeks for AEs; within 30 days of last dose of study drug (up to 82 weeks) for serious AEs.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00765999.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.

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