Phase III, Randomized, Double-Blind, Placebo-Controlled, Trial of Linaclotide Administered to Patients With Chronic Constipation

December 19, 2012 updated by: Forest Laboratories

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial of Linaclotide Administered Orally for 12 Weeks in Patients With Chronic Constipation

The objective of this trial is to determine the efficacy and safety of linaclotide administered to patients with chronic constipation (CC). The primary efficacy parameter is the percentage of patients in each treatment group that meet the protocol definition for Complete Spontaneous Bowel Movement (CSBM) Overall Responder

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
633

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V67 2K5
        • Forest Investigative Site
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • Forest Investigative Site
      • Newmarket, Ontario, Canada, L3Y 7V1
        • Forest Investigative Site
      • Ottawa, Ontario, Canada, K2c 3R2
        • Forest Investigative Site
      • Sarnia, Ontario, Canada, N7T 4X3
        • Forest Investigative Site 1
      • Sarnia, Ontario, Canada, N7T 4X3
        • Forest Investigative Site 2
      • Sudbury, Ontario, Canada, P3E 1H5
        • Forest Investigative Site
      • Toronto, Ontario, Canada, MCN 2V7
        • Forest Investigative Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Forest Investigative Site
      • Birmingham, Alabama, United States, 35215
        • Forest Investigative Site
      • Huntsville, Alabama, United States, 35801
        • Forest Investigative Site
    • Arizona
      • Chandler, Arizona, United States, 85225
        • Forest Investigative Site
      • Mesa, Arizona, United States, 85210
        • Forest Investigative Site
      • Peoria, Arizona, United States, 85381
        • Forest Investigative Site
      • Phoenix, Arizona, United States, 85012
        • Forest Investigative Site
      • Scottsdale, Arizona, United States, 85251
        • Forest Investigative Site
      • Tucson, Arizona, United States, 85741
        • Forest Investigative Site
    • California
      • Burbank, California, United States, 91505
        • Forest Investigative Site
      • Encinitas, California, United States, 92024
        • Forest Investigative Site
      • Foothill Ranch, California, United States, 92610
        • Forest Investigative Site
      • Los Angeles, California, United States, 90036
        • Forest Investigative Site
      • Orange, California, United States, 92869
        • Forest Investigative Site
      • Westlake Village, California, United States, 91361
        • Forest Investigative Site
    • Colorado
      • Boulder, Colorado, United States, 80304
        • Forest Investigative Site
      • Colorado Springs, Colorado, United States, 80909
        • Forest Investigative Site
      • Denver, Colorado, United States, 80205
        • Forest Investigative Sites
      • Longmont, Colorado, United States, 80501
        • Forest Investigative Site
      • Wheat Ridge, Colorado, United States, 80033
        • Forest Investigative Site
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • Forest Investigative Site
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Forest Investigative Site
      • Bradenton, Florida, United States, 34203
        • Forest Investigative Site
      • Brooksville, Florida, United States, 34601
        • Forest Investigative Site
      • Ft. Myers, Florida, United States, 33916
        • Forest Investigative Site
      • Jupiter, Florida, United States, 33458
        • Forest Investigative Site
      • Kissimmee, Florida, United States, 34741
        • Forest Investigative Site
      • Miami, Florida, United States, 33143
        • Forest Investigative Site
      • Ocala, Florida, United States, 34471
        • Forest Investigative Site
      • Orlando, Florida, United States, 32806
        • Forest Investigative Site
      • Panama City, Florida, United States, 32405
        • Forest Investigative Site
      • Pembroke Pines, Florida, United States, 33024
        • Forest Investigative Site
      • St. Petersburg, Florida, United States, 33709
        • Forest Investigative Site
      • Tampa, Florida, United States, 33606
        • Forest Investigative Site
      • Trinity, Florida, United States, 34655
        • Forest Investigative Site
      • Zephyrhills, Florida, United States, 33542
        • Forest Investigative Site
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Forest Investigative Site
      • Marietta, Georgia, United States, 30060
        • Forest Investigative Site
      • Marietta, Georgia, United States, 30067
        • Forest Investigative Site
      • Stockbridge, Georgia, United States, 30281
        • Forest Investigative Site
      • Woodstock, Georgia, United States, 30189
        • Forest Investigative Site
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Forest Investigative Site
    • Illinois
      • Rockford, Illinois, United States, 61107
        • Forest Investigative Site
    • Indiana
      • Elkhart, Indiana, United States, 46514
        • Forest Investigative Site
      • Evansville, Indiana, United States, 47714
        • Forest Investigative Site
      • Indianapolis, Indiana, United States, 46237
        • Forest Investigative Site
      • Indianapolis, Indiana, United States, 46254
        • Forest Investigative Site
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Forest Investigative Site
    • Kansas
      • Arkansas City, Kansas, United States, 67005
        • Forest Investigative Site
      • Newton, Kansas, United States, 67114
        • Forest Investigative Site
      • Wichita, Kansas, United States, 67205
        • Forest Investigative Site
      • Wichita, Kansas, United States, 67207
        • Forest Investigative Site
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Forest Investigative Site
      • Madisonville, Kentucky, United States, 42431
        • Forest Investigative Site
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Forest Investigative Site
      • Hagerstown, Maryland, United States, 21742
        • Forest Investigative Site
      • Lutherville, Maryland, United States, 21093
        • Forest Investigative Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02135
        • Forest Investigative Site
    • Minnesota
      • Chaska, Minnesota, United States, 55318
        • Forest Investigative Site
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Forest Investigative Site
      • St. Louis, Missouri, United States, 63128
        • Forest Investigative Site
    • New Jersey
      • Vineland, New Jersey, United States, 08360
        • Forest Investigative Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Forest Investigative Site
    • New York
      • Brooklyn, New York, United States, 11214
        • Forest Investigative Site
      • Great Neck, New York, United States, 11021
        • Forest Investigative Site
      • Great Neck, New York, United States, 11023
        • Forest Investigative Site
    • North Carolina
      • Fayetteville, North Carolina, United States, 28304
        • Forest Investigative Site
      • Greensboro, North Carolina, United States, 27403
        • Forest Investigative Site
      • Hickory, North Carolina, United States, 28601
        • Forest Investigative Site
      • Raleigh, North Carolina, United States, 27612
        • Forest Investigative Site
      • Wilmington, North Carolina, United States, 28401
        • Forest Investigative Site
      • Winston-Salem, North Carolina, United States, 27103
        • Forest Investigative Site
    • North Dakota
      • Bismark, North Dakota, United States, 58501
        • Forest Investigative Site
    • Ohio
      • Akron, Ohio, United States, 44302
        • Forest Investigative Site
      • Cincinnati, Ohio, United States, 45219
        • Forest Investigative Site
      • Cleveland, Ohio, United States, 44122
        • Forest Investigative Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Forest Investigative Site
      • Tulsa, Oklahoma, United States, 74135
        • Forest Investigative Site
    • Pennsylvania
      • Bensalem, Pennsylvania, United States, 19020
        • Forest Investigative Site
      • Pittsburgh, Pennsylvania, United States, 15206
        • Forest Investigative Site
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Forest Investigative Site
      • Greer, South Carolina, United States, 29651
        • Forest Investigative Site
    • Tennessee
      • Nashville, Tennessee, United States, 37205
        • Forest Investigative Site
    • Texas
      • Austin, Texas, United States, 78705
        • Forest Investigative Site
      • Dallas, Texas, United States, 75234
        • Forest Investigative Site
      • Houston, Texas, United States, 77090
        • Forest Investigative Site
      • Lake Jackson, Texas, United States, 77566
        • Forest Investigative Site
      • San Antonio, Texas, United States, 78229
        • Forest Investigative Site
      • San Antonio, Texas, United States, 78209
        • Forest Investigative Site
    • Utah
      • Salt Lake City, Utah, United States, 84102
        • Forest Investigative Site
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • Forest Investigative Site
      • Christianburg, Virginia, United States, 24073
        • Forest Investigative Site
      • Newport News, Virginia, United States, 23606
        • Forest Investigative Site
      • Norfolk, Virginia, United States, 23502
        • Forest Investigative Site
      • Norfolk, Virginia, United States, 23507
        • Forest Investigative Site
      • Richmond, Virginia, United States, 23294
        • Forest Investigative Site
    • Washington
      • Bellevue, Washington, United States, 98402
        • Forest Investigative Site
      • Lakewood, Washington, United States, 98499
        • Forest Investigative Site
      • Wenatchee, Washington, United States, 98801
        • Forest Investigative Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53209
        • Forest Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient has completed a colonoscopy according to the AGA criteria, with no clinically significant findings
  • Patient has successfully completed protocol procedures (with no clinically significant findings): physical exam, 12-lead ECG, or clinical laboratory tests
  • Patient meets protocol criteria for CC: reports < 3 bowel movements per week and reports straining, lumpy or hard stools, and/or sensation of incomplete evacuation during > 25% of BMs
  • Patient demonstrates continued chronic constipation through Pretreatment Period
  • Patient is compliant with IVRS

Exclusion Criteria:

  • Patient has history of loose or watery stools
  • Patient has symptoms of or been diagnosed with Irritable Bowel Syndrome (IBS)
  • Patient has a structural abnormality of the gastrointestinal (GI) tract or a disease or condition that can affect GI motility
  • Patient has any protocol-excluded or clinically significant medical or surgical history that could confound the study assessments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 1
Linaclotide 290 micrograms
Drug: Linaclotide 290 micrograms
Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study
Experimental: 2
Linaclotide 145 micrograms
Drug: Linaclotide 145 micrograms
Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study
Placebo Comparator: 3
Matching placebo
Drug: Placebo
Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Complete Spontaneous Bowel Movement (CSBM) Overall Responder
Time Frame: Change from Baseline to Week 12

A 12-week CSBM overall responders was defined as a patient who for at least 9 of the 12 weeks of the treatment period had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline.

A CSBM was defined as a spontaneous bowel movement (SBM) that was associated with a sense of complete evacuation.

An SBM was defined as a bowel movement (BM) that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM.
Change from Baseline to Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
12-week Complete Spontaneous Bowel Movement (CSBM) Frequency Rate
Time Frame: Change from Baseline to Week 12
The number of CSBMs per week.
Change from Baseline to Week 12
12-Week Spontaneous Bowel Movement (SBM) Frequency Rate
Time Frame: Change from Baseline to Week 12
A patient's 12-week spontaneous bowel movement (SBM) frequency rate was the number of SBMs per week calculated over the 12-weeks of the treatment period.
Change from Baseline to Week 12
12-Week Stool Consistency
Time Frame: Change from Baseline to Week 12

The consistency of each BM was assessed using the 7-point Bristol Stool Form Scale:

  1. = separate hard lumps like nuts [difficult to pass]
  2. = sausage shaped but lumpy
  3. = like a sausage but with cracks on surface
  4. = like a sausage or snake, smooth and soft
  5. = soft blobs with clear-cut edges [passed easily]
  6. = fluffy pieces with ragged edges, a mushy stool
  7. = watery, no solid pieces [entirely liquid]
Change from Baseline to Week 12
12-Week Severity of Straining
Time Frame: Change from Baseline to Week 12
Straining is measured on a 5-point scale, where a value of 1 is "not at all" and a value of 5 is "an extreme amount.
Change from Baseline to Week 12
12-Week Abdominal Discomfort
Time Frame: Change from Baseline to Week 12
Abdominal discomfort is based on a 5-point scale where a value of l is "none" and a value of 5 is "very severe."
Change from Baseline to Week 12
12-Week Bloating
Time Frame: Change from Baseline to Week 12
Bloating was based on a 5-point scale where a value of l is "none" and a value of 5 is "very severe".
Change from Baseline to Week 12
12-Week Constipation Severity
Time Frame: Change from Baseline to Week 12
Constipation severity was based on a 5-point ordinal scale where a value of l is "none" and a value of 5 is "very severe".
Change from Baseline to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Forest Laboratories

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ironwood Pharmaceuticals, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Paul F.C. Eng, PhD, Forest Laboratories

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 1, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 3, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 30, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LIN-MD-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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