Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

NCT00938717 | Completed Phase 3 Results

• 1 other identifier: MCP-103-302
• Study Type: interventional
• Target: 805
• Locations: 1 country
• Sites: 107

Brief Summary

The purpose of this study is to determine the safety and efficacy of linaclotide administered to patients with Irritable Bowel Syndrome with Constipation (IBS-C).

Conditions

Irritable Bowel Syndrome With Constipation

Keywords

IBS

Outcome Measures

Primary Outcomes (4)

• Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 9 Out of 12 Weeks

  A patient is considered to be a 9 out of 12 week APC responder if, for at least 9 out of the first 12 weeks of the treatment period, the patient had at least 3 CSBMs, had an increase of at least 1 CSBM from baseline, and had a decrease of at least 30 percent in their Abdominal Pain (AP) score from baseline during a particular week. The AP score assesses patient's worst AP in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no AP and 10 represents very severe AP. SBM is defined as a bowel movement that occurs in the absence of laxative, enema, or suppository use on either the calendar day of the bowel movement or the calendar day before the bowel movement. CSBM is defined as an SBM associated with a sense of complete evacuation.

  Change from Baseline to Week 12

• Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder, 9 Out of 12 Weeks

  A patient is considered to be a CSBM 3+1 responder if, for at least 9 out of the 12 weeks of the treatment period, the patient had at least 3 CSBMs and experienced an increase of at least 1 CSBM from baseline during a particular week. 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

• Abdominal Pain Responder, 9 Out of 12 Weeks

  A patient is considered to be an abdominal pain responder if, for at least 9 out of the 12 weeks of the treatment period, they experienced a decrease of at least 30 percent in the mean abdominal pain score from baseline during a particular week. The Abdominal Pain score assesses patient's worst abdominal pain in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no abdominal pain and 10 represents very severe abdominal pain.

  Change from Baseline to Week 12

• Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 6 Out of 12 Weeks

  A patient is considered to be a 6 out of 12 week APC responder if, for at least 6 out of the first 12 weeks of the treatment period, the patient had an increase of at least 1 CSBM from baseline, and had a decrease of at least 30 percent in their Abdominal Pain (AP) score from baseline during a particular week. The AP score assesses patient's worst AP in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no AP and 10 represents very severe AP. SBM is defined as a bowel movement that occurs in the absence of laxative, enema, or suppository use on either the calendar day of the bowel movement or the calendar day before the bowel movement. CSBM is defined as an SBM associated with a sense of complete evacuation.

  Change from Baseline to Week 12

Secondary Outcomes (10)

• 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 Pain Score

  Change from Baseline to Week 12

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Linaclotide or Matching Placebo

290 μg Linaclotide

EXPERIMENTAL

Drug: Linaclotide or Matching Placebo

Interventions

Linaclotide or Matching Placebo DRUG

Linaclotide or Matching Placebo, administered orally, once daily, for the duration of the trial

290 μg Linaclotide; Placebo

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 diagnosis of IBS-C
• Patient demonstrates continued IBS-C 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 a medical condition that may contribute to abdominal pain
• 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 (107)

Ironwood Investigational Site

Birmingham, Alabama, 35209, United States

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Huntsville, Alabama, 35801, United States

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Phoenix, Arizona, 85014, United States

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Tempe, Arizona, 85282, United States

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Tucson, Arizona, 85710, United States

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Tucson, Arizona, 85741, 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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Orange, California, 92868, 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, 06011, 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, 32205, United States

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Jacksonville, Florida, 32207, United States

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Lauderdale Lakes, Florida, 33319, United States

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Miami, Florida, 33156, United States

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Pinellas Park, Florida, 33782, 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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Metairie, Louisiana, 70006, 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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Plymouth, Minnesota, 55446, 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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Marlton, New Jersey, 08053, 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, 28209, United States

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Charlotte, North Carolina, 28211, United States

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Greensboro, North Carolina, 27401, 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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Huntersville, North Carolina, 28078, 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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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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Mentor, Ohio, 44060, United States

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Sylvania, Ohio, 43560, United States

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Wadsworth, Ohio, 44281, 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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Levittown, Pennsylvania, 19056, United States

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Reading, Pennsylvania, 19606, United States

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Sellersville, Pennsylvania, 18960, United States

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Washington, Pennsylvania, 15301, 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, 29581, United States

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Summerville, South Carolina, 29485, United States

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Bristol, Tennessee, 37620, United States

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Chattanooga, Tennessee, 37404, United States

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Germantown, Tennessee, 38183, 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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Fort Worth, Texas, 76104, 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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Sugarland, Texas, 77479, 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)

• Rao SS, Quigley EM, Shiff SJ, Lavins BJ, Kurtz CB, MacDougall JE, Currie MG, Johnston JM. Effect of linaclotide on severe abdominal symptoms in patients with irritable bowel syndrome with constipation. Clin Gastroenterol Hepatol. 2014 Apr;12(4):616-23. doi: 10.1016/j.cgh.2013.09.022. Epub 2013 Sep 25.

  PMID: 24075889 DERIVED

• Quigley EM, Tack J, Chey WD, Rao SS, Fortea J, Falques M, Diaz C, Shiff SJ, Currie MG, Johnston JM. Randomised clinical trials: linaclotide phase 3 studies in IBS-C - a prespecified further analysis based on European Medicines Agency-specified endpoints. Aliment Pharmacol Ther. 2013 Jan;37(1):49-61. doi: 10.1111/apt.12123. Epub 2012 Nov 1.

  PMID: 23116208 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: July 12, 2009
• First Posted: July 14, 2009
• Study Start: July 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: November 5, 2013
• Results First Posted: January 30, 2013

Record last verified: 2013-10

Locations

US (107)