Trial of Linaclotide in Patients With Chronic Constipation

NCT00730015 | Completed Phase 3 Results

• 1 other identifier: MCP-103-303
• Study Type: interventional
• Target: 643
• Locations: 1 country
• Sites: 105

Brief Summary

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.

Conditions

Chronic Constipation

Outcome Measures

Primary Outcomes (1)

• Complete Spontaneous Bowel Movement (CSBM) Overall Responder

  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.

  Change from Baseline to Week 12

Secondary Outcomes (7)

• 12-Week Complete Spontaneous Bowel Movement (CSBM) Frequency

  Change from Baseline to Week 12

• 12-Week Spontaneous Bowl Movement (SBM) Frequency

  Change from Baseline to Week 12

• 12-week Change in Stool Consistency

  Change from Baseline to Week 12

• 12-week Change in Severity of Straining

  Change from Baseline to Week 12

• 12-week Change in Abdominal Discomfort

  Change from Baseline to Week 12

Study Arms (3)

145 μg linaclotide

EXPERIMENTAL

Drug: Linaclotide

290 μg linaclotide

EXPERIMENTAL

Drug: Linaclotide

Matching Placebo

PLACEBO COMPARATOR

Drug: Matching Placebo

Interventions

Matching Placebo DRUG

Oral, once daily

Matching Placebo

Linaclotide DRUG

Oral, once daily

145 μg linaclotide; 290 μg linaclotide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ironwood Pharmaceuticals, Inc.: lead
• Forest Laboratories: collaborator

Study Sites (105)

Ironwood Investigational Site

Birmingham, Alabama, 35209, United States

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Ironwood Investigational Site

Huntsville, Alabama, 35801, United States

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Chandler, Arizona, 85224, United States

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Phoenix, Arizona, 85020, United States

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Tucson, Arizona, 85715, United States

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Tuscon, Arizona, 85710, United States

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Sherwood, Arkansas, 72120, United States

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Anaheim, California, 92801, United States

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Chula Vista, California, 91910, United States

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Encinitas, California, 92024, United States

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Garden Grove, California, 92840, United States

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Laguna Hills, California, 92653, United States

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Los Angeles, California, 90045, United States

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Orange, California, 92868, United States

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Sacramento, California, 95830, United States

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San Carlos, California, 94070, United States

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San Diego, California, 92103, United States

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San Diego, California, 92108, United States

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San Diego, California, 92123, United States

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Colorado Springs, Colorado, 80904, United States

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Bristol, Connecticut, 06010, United States

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Boynton Beach, Florida, 33426, United States

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Hollywood, Florida, 33021, United States

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Inverness, Florida, 34452, United States

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Jacksonville, Florida, 32256, United States

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Port Orange, Florida, 32129, United States

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Tampa, Florida, 33607, United States

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Newnan, Georgia, 30263, United States

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Peoria, Illinois, 61602, United States

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Anderson, Indiana, 46011, United States

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Clive, Iowa, 50325, United States

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Davenport, Iowa, 52807, United States

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Mission, Kansas, 66202, United States

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Overland Park, Kansas, 66215, United States

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Topeka, Kansas, 66606, United States

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Baton Rouge, Louisiana, 70809, United States

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Monroe, Louisiana, 71201, United States

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Shreveport, Louisiana, 71103, United States

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Annapolis, Maryland, 21401, United States

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Baltimore, Maryland, 21215, United States

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Hollywood, Maryland, 20636, United States

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Laurel, Maryland, 20707, United States

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Chesterfield, Michigan, 48047, United States

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Traverse City, Michigan, 49684, United States

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Troy, Michigan, 48098, United States

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Jackson, Mississippi, 39202, United States

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Tupelo, Mississippi, 38801, United States

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Jefferson City, Missouri, 65109, United States

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Henderson, Nevada, 89104, United States

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Las Vegas, Nevada, 89128, United States

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Cedar Knolls, New Jersey, 07927, United States

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Marlton, New Jersey, 08053, United States

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Ocean City, New Jersey, 07712, United States

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Albuquerque, New Mexico, 87108, United States

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Mineola, New York, 11501, United States

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Pittsford, New York, 14534, United States

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Asheboro, North Carolina, 27203, United States

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Asheville, North Carolina, 28801, United States

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Chapel Hill, North Carolina, 27599, United States

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Charlotte, North Carolina, 28211, United States

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Greensboro, North Carolina, 27408, United States

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Harrisburg, North Carolina, 28075, United States

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Hickory, North Carolina, 28602, United States

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Jacksonville, North Carolina, 28546, United States

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New Bern, North Carolina, 28562, United States

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Statesville, North Carolina, 28625, United States

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Summerville, North Carolina, 29485, United States

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Wilmington, North Carolina, 28401, United States

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Winston-Salem, North Carolina, 27103, United States

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Beachwood, Ohio, 44122, United States

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Cincinnati, Ohio, 45224, United States

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Cincinnati, Ohio, 45242, United States

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Dayton, Ohio, 45440, United States

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Sylvania, Ohio, 43560, United States

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Wadsworth, Ohio, 44281, United States

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Zanesville, Ohio, 43701, United States

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Oklahoma City, Oklahoma, 73116, United States

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Yukon, Oklahoma, 73099, United States

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Lancaster, Pennsylvania, 17604, United States

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Lancaster, Pennsylvania, 19606, United States

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Levittown, Pennsylvania, 19056, United States

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Pittsburgh, Pennsylvania, 15213, United States

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Sellersville, Pennsylvania, 18960, United States

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Anderson, South Carolina, 29621, United States

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Charleston, South Carolina, 29414, United States

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Simpsonville, South Carolina, 29681, United States

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Bristol, Tennessee, 37620, United States

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Chattanooga, Tennessee, 37421, United States

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Germantown, Tennessee, 38138, United States

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Kingsport, Tennessee, 37660, United States

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Nashville, Tennessee, 37203, United States

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Beaumont, Texas, 77701, United States

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El Paso, Texas, 79905, United States

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Houston, Texas, 77024, United States

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Irving, Texas, 75061, United States

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Longview, Texas, 75605, United States

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San Antonio, Texas, 78229, United States

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Ogden, Utah, 84405, United States

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Salt Lake City, Utah, 84107, United States

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Chesapeake, Virginia, 23320, United States

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Lynchburg, Virginia, 24502, United States

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Spokane, Washington, 99208, United States

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Vancouver, Washington, 98664, United States

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La Crosse, Wisconsin, 54601, United States

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Ironwood Investigational Site

Milwaukee, Wisconsin, 53215, United States

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Related Publications (2)

• Chang L, Lembo AJ, Lavins BJ, Shiff SJ, Hao X, Chickering JG, Jia XD, Currie MG, Kurtz CB, Johnston JM. The impact of abdominal pain on global measures in patients with chronic idiopathic constipation, before and after treatment with linaclotide: a pooled analysis of two randomised, double-blind, placebo-controlled, phase 3 trials. Aliment Pharmacol Ther. 2014 Dec;40(11-12):1302-12. doi: 10.1111/apt.12985. Epub 2014 Oct 13.

  PMID: 25312449 DERIVED

• Lembo AJ, Schneier HA, Shiff SJ, Kurtz CB, MacDougall JE, Jia XD, Shao JZ, Lavins BJ, Currie MG, Fitch DA, Jeglinski BI, Eng P, Fox SM, Johnston JM. Two randomized trials of linaclotide for chronic constipation. N Engl J Med. 2011 Aug 11;365(6):527-36. doi: 10.1056/NEJMoa1010863.

  PMID: 21830967 DERIVED

MeSH Terms

Interventions

linaclotide

Results Point of Contact

• Title: Doug Levine, MD
• Organization: Ironwood Pharmaceuticals

dlevine@ironwoodpharma.com

617.374.3906

Study Officials

• Jeffrey M. Johnston, MD, FACP

  Ironwood Pharmaceuticals, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2008
• First Posted: August 8, 2008
• Study Start: August 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: October 1, 2009
• Last Updated: January 30, 2013
• Results First Posted: January 30, 2013

Record last verified: 2012-12

Locations

US (105)