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Trial of Linaclotide in Patients With Chronic Constipation

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Ironwood Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00730015
First received: August 5, 2008
Last updated: December 19, 2012
Last verified: December 2012
History of Changes
  Purpose

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 dosing group that meet the protocol definition for Complete Spontaneous Bowel Movement (CSBM) Overall Responder.


Condition Intervention Phase
Chronic Constipation
 Drug: Matching Placebo
Drug: Linaclotide
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial of Linaclotide Administered Orally for 12 Weeks Followed by a 4-Week Randomized Withdrawal Period in Patients With Chronic Constipation

Resource links provided by NLM:

Drug Information available for: Linaclotide
U.S. FDA Resources

Further study details as provided by Ironwood Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Complete Spontaneous Bowel Movement (CSBM) Overall Responder [ Time Frame: Change from Baseline to Week 12 ] [ Designated as safety issue: No ]

    A 12-week CSBM Overall Responder 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.



Secondary Outcome Measures:
  • 12-Week Complete Spontaneous Bowel Movement (CSBM) Frequency [ Time Frame: Change from Baseline to Week 12 ] [ Designated as safety issue: No ]
    The number of CSBMs per week.

  • 12-Week Spontaneous Bowl Movement (SBM) Frequency [ Time Frame: Change from Baseline to Week 12 ] [ Designated as safety issue: No ]
    The number of SBMs per week.

  • 12-week Change in Stool Consistency [ Time Frame: Change from Baseline to Week 12 ] [ Designated as safety issue: No ]

    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]

  • 12-week Change in Severity of Straining [ Time Frame: Change from Baseline to Week 12 ] [ Designated as safety issue: No ]
    Severity of 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".

  • 12-week Change in Abdominal Discomfort [ Time Frame: Change from Baseline to Week 12 ] [ Designated as safety issue: No ]
    Abdominal discomfort is based on a 5-point scale where a value of l is "none" and a value of 5 is "very severe."

  • 12-week Change in Bloating [ Time Frame: Change from Baseline to Week 12 ] [ Designated as safety issue: No ]
    Bloating was based on a 5-point scale where a value of l is "none" and a value of 5 is "very severe".

  • 12-week Change in Constipation Severity [ Time Frame: Change from Baseline to Week 12 ] [ Designated as safety issue: No ]
    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".


Enrollment: 643
Study Start Date: August 2008
Study Completion Date: October 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 145 μg linaclotide Drug: Linaclotide
Oral, once daily
Experimental: 290 μg linaclotide Drug: Linaclotide
Oral, once daily
Placebo Comparator: Matching Placebo Drug: Matching Placebo
Oral, once daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00730015

  Hide Study Locations
Locations
United States, Alabama
Ironwood Investigational Site
Birmingham, Alabama, United States, 35209
Ironwood Investigational Site
Huntsville, Alabama, United States, 35801
United States, Arizona
Ironwood Investigational Site
Chandler, Arizona, United States, 85224
Ironwood Investigational Site
Phoenix, Arizona, United States, 85020
Ironwood Investigational Site
Tucson, Arizona, United States, 85715
Ironwood Investigational Site
Tuscon, Arizona, United States, 85710
United States, Arkansas
Ironwood Investigational Site
Sherwood, Arkansas, United States, 72120
United States, California
Ironwood Investigational Site
Anaheim, California, United States, 92801
Ironwood Investigational Site
Chula Vista, California, United States, 91910
Ironwood Investigational Site
Encinitas, California, United States, 92024
Ironwood Investigational Site
Garden Grove, California, United States, 92840
Ironwood Investigational Site
Laguna Hills, California, United States, 92653
Ironwood Investigational Site
Los Angeles, California, United States, 90045
Ironwood Investigational Site
Orange, California, United States, 92868
Ironwood Investigational Site
Sacramento, California, United States, 95830
Ironwood Investigational Site
San Carlos, California, United States, 94070
Ironwood Investigational Site
San Diego, California, United States, 92103
Ironwood Investigational Site
San Diego, California, United States, 92123
Ironwood Investigational Site
San Diego, California, United States, 92108
United States, Colorado
Ironwood Investigational Site
Colorado Springs, Colorado, United States, 80904
United States, Connecticut
Ironwood Investigational Site
Bristol, Connecticut, United States, 06010
United States, Florida
Ironwood Investigational Site
Boynton Beach, Florida, United States, 33426
Ironwood Investigational Site
Hollywood, Florida, United States, 33021
Ironwood Investigational Site
Inverness, Florida, United States, 34452
Ironwood Investigational Site
Jacksonville, Florida, United States, 32256
Ironwood Investigational Site
Port Orange, Florida, United States, 32129
Ironwood Investigational Site
Tampa, Florida, United States, 33607
United States, Georgia
Ironwood Investigational Site
Newnan, Georgia, United States, 30263
United States, Illinois
Ironwood Investigational Site
Peoria, Illinois, United States, 61602
United States, Indiana
Ironwood Investigational Site
Anderson, Indiana, United States, 46011
United States, Iowa
Ironwood Investigational Site
Clive, Iowa, United States, 50325
Ironwood Investigational Site
Davenport, Iowa, United States, 52807
United States, Kansas
Ironwood Investigational Site
Mission, Kansas, United States, 66202
Ironwood Investigational Site
Overland Park, Kansas, United States, 66215
Ironwood Investigational Site
Topeka, Kansas, United States, 66606
United States, Louisiana
Ironwood Investigational Site
Baton Rouge, Louisiana, United States, 70809
Ironwood Investigational Site
Monroe, Louisiana, United States, 71201
Ironwood Investigational Site
Shreveport, Louisiana, United States, 71103
United States, Maryland
Ironwood Investigational Site
Annapolis, Maryland, United States, 21401
Ironwood Investigational Site
Baltimore, Maryland, United States, 21215
Ironwood Investigational Site
Hollywood, Maryland, United States, 20636
Ironwood Investigational Site
Laurel, Maryland, United States, 20707
United States, Michigan
Ironwood Investigational Site
Chesterfield, Michigan, United States, 48047
Ironwood Investigational Site
Traverse City, Michigan, United States, 49684
Ironwood Investigational Site
Troy, Michigan, United States, 48098
United States, Mississippi
Ironwood Investigational Site
Jackson, Mississippi, United States, 39202
Ironwood Investigational Site
Tupelo, Mississippi, United States, 38801
United States, Missouri
Ironwood Investigational Site
Jefferson City, Missouri, United States, 65109
United States, Nevada
Ironwood Investigational Site
Henderson, Nevada, United States, 89104
Ironwood Investigational Site
Las Vegas, Nevada, United States, 89128
United States, New Jersey
Ironwood Investigational Site
Cedar Knolls, New Jersey, United States, 07927
Ironwood Investigational Site
Marlton, New Jersey, United States, 08053
Ironwood Investigational Site
Ocean, New Jersey, United States, 07712
United States, New Mexico
Ironwood Investigational Site
Albuquerque, New Mexico, United States, 87108
United States, New York
Ironwood Investigational Site
Mineola, New York, United States, 11501
Ironwood Investigational Site
Pittsford, New York, United States, 14534
United States, North Carolina
Ironwood Investigational Site
Asheboro, North Carolina, United States, 27203
Ironwood Investigational Site
Asheville, North Carolina, United States, 28801
Ironwood Investigational Site
Chapel Hill, North Carolina, United States, 27599
Ironwood Investigational Site
Charlotte, North Carolina, United States, 28211
Ironwood Investigational Site
Greensboro, North Carolina, United States, 27408
Ironwood Investigational Site
Harrisburg, North Carolina, United States, 28075
Ironwood Investigational Site
Hickory, North Carolina, United States, 28602
Ironwood Investigational Site
Jacksonville, North Carolina, United States, 28546
Ironwood Investigational Site
New Bern, North Carolina, United States, 28562
Ironwood Investigational Site
Statesville, North Carolina, United States, 28625
Ironwood Investigational Site
Summerville, North Carolina, United States, 29485
Ironwood Investigational Site
Wilmington, North Carolina, United States, 28401
Ironwood Investigational Site
Winston Salem, North Carolina, United States, 27103
United States, Ohio
Ironwood Investigational Site
Beachwood, Ohio, United States, 44122
Ironwood Investigational Site
Cincinnati, Ohio, United States, 45224
Ironwood Investigational Site
Cincinnati, Ohio, United States, 45242
Ironwood Investigational Site
Dayton, Ohio, United States, 45440
Ironwood Investigational Site
Sylvania, Ohio, United States, 43560
Ironwood Investigational Site
Wadsworth, Ohio, United States, 44281
Ironwood Investigational Site
Zanesville, Ohio, United States, 43701
United States, Oklahoma
Ironwood Investigational Site
Oklahoma City, Oklahoma, United States, 73116
Ironwood Investigational Site
Yukon, Oklahoma, United States, 73099
United States, Pennsylvania
Ironwood Investigational Site
Lancaster, Pennsylvania, United States, 17604
Ironwood Investigational Site
Lancaster, Pennsylvania, United States, 19606
Ironwood Investigational Site
Levittown, Pennsylvania, United States, 19056
Ironwood Investigational Site
Pittsburgh, Pennsylvania, United States, 15213
Ironwood Investigational Site
Sellersville, Pennsylvania, United States, 18960
United States, South Carolina
Ironwood Investigational Site
Anderson, South Carolina, United States, 29621
Ironwood Investigational Site
Charleston, South Carolina, United States, 29414
Ironwood Investigational Site
Simpsonville, South Carolina, United States, 29681
United States, Tennessee
Ironwood Investigational Site
Bristol, Tennessee, United States, 37620
Ironwood Investigational Site
Chattanooga, Tennessee, United States, 37421
Ironwood Investigational Site
Germantown, Tennessee, United States, 38138
Ironwood Investigational Site
Kingsport, Tennessee, United States, 37660
Ironwood Investigational Site
Nashville, Tennessee, United States, 37203
United States, Texas
Ironwood Investigational Site
Beaumont, Texas, United States, 77701
Ironwood Investigational Site
El Paso, Texas, United States, 79905
Ironwood Investigational Site
Houston, Texas, United States, 77024
Ironwood Investigational Site
Irving, Texas, United States, 75061
Ironwood Investigational Site
Longview, Texas, United States, 75605
Ironwood Investigational Site
San Antonio, Texas, United States, 78229
United States, Utah
Ironwood Investigational Site
Ogden, Utah, United States, 84405
Ironwood Investigational Site
Salt Lake City, Utah, United States, 84107
United States, Virginia
Ironwood Investigational Site
Chesapeake, Virginia, United States, 23320
Ironwood Investigational Site
Lynchburg, Virginia, United States, 24502
United States, Washington
Ironwood Investigational Site
Spokane, Washington, United States, 99208
Ironwood Investigational Site
Vancouver, Washington, United States, 98664
United States, Wisconsin
Ironwood Investigational Site
LaCrosse, Wisconsin, United States, 54601
Ironwood Investigational Site
Milwaukee, Wisconsin, United States, 53215
Sponsors and Collaborators
Ironwood Pharmaceuticals, Inc.
Forest Laboratories
Investigators
Study Chair: Jeffrey M. Johnston, MD, FACP Ironwood Pharmaceuticals, Inc.
  More Information

No publications provided by Ironwood Pharmaceuticals, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Ironwood Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00730015     History of Changes
Other Study ID Numbers: MCP-103-303
Study First Received: August 5, 2008
Results First Received: September 28, 2012
Last Updated: December 19, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013