Trial of Linaclotide in Patients With Chronic Idiopathic Constipation

NCT02291679 | Completed Phase 3 Results

• 1 other identifier: MCP-103-309
• Study Type: interventional
• Target: 1,223
• Locations: 1 country
• Sites: 95

Brief Summary

The objective of this trial was to determine the efficacy and safety of linaclotide 72 ug administered once daily to patients with chronic idiopathic constipation (CIC). The primary efficacy parameter is the percentage of participants in each dosing group that meet the protocol definition for complete spontaneous bowel movement (CSBM) Overall Responder.

Conditions

Chronic Idiopathic Constipation

Outcome Measures

Primary Outcomes (1)

• Percentage of 12-Week CSBM Overall Responders

  A 12-week CSBM Overall Responder is a participant who was a CSBM Weekly Responder for at least 9 of the 12 weeks of the Treatment Period. A CSBM Weekly Responder is a participant who had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline, and completed ≥ 4 IVRS calls for the specified week. A CSBM is defined as an SBM that is associated with a sense of complete evacuation. An SBM is 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.

  Week 12

Secondary Outcomes (10)

• Change From Baseline in 12-Week CSBM Frequency Rate

  Baseline, Week 1 to Week 12

• Change From Baseline in 12-Week SBM Frequency Rate

  Baseline, Week 1 to Week 12

• Change From Baseline in 12-Week Stool Consistency Score

  Baseline, Week 1 to Week 12

• Change From Baseline in 12-Week Straining Score

  Baseline, Week 1 to Week 12

• Percentage of 12-Week CSBM Overall Responders (>1 SBM/Week Subpopulation)

  Week 12

Other Outcomes (1)

• Percentage of 12-Week CSBM Overall Sustained Responders

  Week 12

Study Arms (3)

72 μg linaclotide

EXPERIMENTAL

72 μg oral linaclotide, once daily for 12 weeks

Drug: Linaclotide

145 μg linaclotide

EXPERIMENTAL

145 μg oral linaclotide, once daily for 12 weeks

Drug: Linaclotide

Placebo

PLACEBO COMPARATOR

matching placebo, once daily for 12 weeks

Drug: Matching Placebo

Interventions

Linaclotide DRUG

Also known as: Linzess, Constella

145 μg linaclotide; 72 μg linaclotide

Matching Placebo DRUG

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 if one is needed according to the American Gastroenterological Association (AGA) criteria, with no clinically significant findings
• Patient has no clinically significant findings on a physical examination and clinical laboratory tests
• Patient meets protocol criteria for CIC: reports \< 3 bowel movements (BMs) per week and reports one or more of the following during ≥ 25% of BMs: straining, lumpy or hard stools, sensation of incomplete evacuation during the 3 months before the diagnosis with the onset at least 6 months before the diagnosis
• Patient is compliant with daily interactive voice response system (IVRS) calls
• Patient reports an average of \< 3 complete spontaneous BMs (CSBMs) and ≤ 6 SBMs per week by the IVRS over the 14 calendar days before the Randomization Visit and the calendar day of Randomization.

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
• Patient has Bristol Stool Form Scale score of 7 during Pretreatment period.

Sponsors & Collaborators

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

Study Sites (95)

Ironwood Investigational Site

Huntsville, Alabama, 35801, United States

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Ironwood Investigational Site

Phoenix, Arizona, 85018, United States

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Tucson, Arizona, 85712, United States

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North Little Rock, Arkansas, 72117, United States

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Anaheim, California, 92801, United States

Location

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Chula Vista, California, 91910, United States

Location

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Garden Grove, California, 92843, United States

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La Mesa, California, 91942, United States

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North Hollywood, California, 91606, United States

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Orange, California, 92868, United States

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San Diego, California, 92108, United States

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Thousand Oaks, California, 91360, 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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Coral Gables, Florida, 33134, United States

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DeLand, Florida, 32720, United States

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Hialeah, Florida, 33016, United States

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Inverness, Florida, 34452, United States

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Jupiter, Florida, 33458, United States

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Kissimmee, Florida, 34741, United States

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Lauderdale Lakes, Florida, 33319, United States

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Miami, Florida, 33015, United States

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Miami, Florida, 33126, United States

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Miami, Florida, 33133, United States

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Miami, Florida, 33135, United States

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Miami, Florida, 33165, United States

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Miami, Florida, 33175, United States

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Orlando, Florida, 32806, United States

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Ormond Beach, Florida, 32174, United States

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Port Orange County, Florida, 32129, United States

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South Miami, Florida, 33143, United States

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Tampa, Florida, 33634, United States

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West Palm Beach, Florida, 33409, United States

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Winter Park, Florida, 32792, United States

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Atlanta, Georgia, 30328, United States

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Oakwood, Georgia, 30566, United States

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Sandy Springs, Georgia, 30328, United States

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Evansville, Indiana, 47714, United States

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Bastrop, Louisiana, 71220, United States

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Metairie, Louisiana, 70006, United States

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Shreveport, Louisiana, 71103, United States

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Baltimore, Maryland, 21215, United States

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Chevy Chase, Maryland, 20815, United States

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Hagerstown, Maryland, 21740, United States

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Hollywood, Maryland, 20636, United States

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Boston, Massachusetts, 02135, United States

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Wellesley, Massachusetts, 02481, United States

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Chesterfield, Michigan, 48047, United States

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Troy, Michigan, 48098, United States

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Wyoming, Michigan, 49519, United States

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Jackson, Mississippi, 39202, United States

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St Louis, Missouri, 63128, United States

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Bozeman, Montana, 59718, United States

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Las Vegas, Nevada, 89119, United States

Location

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Las Vegas, Nevada, 89121, United States

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Brooklyn, New York, 11206, United States

Location

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Endwell, New York, 13760, United States

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Great Neck, New York, 11023, United States

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Charlotte, North Carolina, 28209, United States

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Charlotte, North Carolina, 28226, United States

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Greensboro, North Carolina, 27403, United States

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High Point, North Carolina, 27262, United States

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Lenoir, North Carolina, 28645, United States

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Raleigh, North Carolina, 27612, 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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Fargo, North Dakota, 58103, United States

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Cincinnati, Ohio, 45219, United States

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Cincinnati, Ohio, 45224, United States

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Columbus, Ohio, 43214, United States

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Mentor, Ohio, 44060, United States

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Sylvania, Ohio, 43560, United States

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Oklahoma City, Oklahoma, 73112, United States

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Levittown, Pennsylvania, 19056, United States

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Anderson, South Carolina, 29621, United States

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Greer, South Carolina, 29651, United States

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Simpsonville, South Carolina, 29681, United States

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Dakota Dunes, South Dakota, 57049, United States

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Bristol, Tennessee, 37620, United States

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Chattanooga, Tennessee, 37421, United States

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Knoxville, Tennessee, 37919, United States

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Beaumont, Texas, 77701, United States

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Ironwood Investigational Site

Dallas, Texas, 75230, United States

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Ironwood Investigational Site

El Paso, Texas, 79905, United States

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Ironwood Investigational Site

Houston, Texas, 77074, United States

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Ironwood Investigational Site

Houston, Texas, 77098, United States

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Ironwood Investigational Site

Longview, Texas, 75605, United States

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Ironwood Investigational Site

San Antonio, Texas, 78209, United States

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Ironwood Investigational Site

San Antonio, Texas, 78229, United States

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Ironwood Investigational Site

San Antonio, Texas, 78258, United States

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Ironwood Investigational Site

South Ogden, Utah, 84405, United States

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Ironwood Investigational Site

Christiansburg, Virginia, 24073, United States

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Ironwood Investigational Site

Lynchburg, Virginia, 24502, United States

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Ironwood Investigational Site

La Crosse, Wisconsin, 54601, United States

Location

MeSH Terms

Interventions

linaclotide

Results Point of Contact

• Title: Michael Hall, MD
• Organization: Ironwood Pharmaceuticals, Inc.

(617) 621-7722

Study Officials

• Bernard J Lavins, MD

  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: November 11, 2014
• First Posted: November 14, 2014
• Study Start: October 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: June 15, 2017
• Results First Posted: May 19, 2017

Record last verified: 2017-05

Locations

US (95)