An Open-label, Long-term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation

NCT00730171 | Completed Phase 3 Results FDA Drug

• 1 other identifier: MCP-103-305
• Study Type: interventional
• Target: 1,743
• Locations: 1 country
• Sites: 116

Brief Summary

The objective of this study is to assess the long-term safety of linaclotide administered to patients with chronic constipation (CC) or irritable bowel syndrome with constipation (IBS-C).

Conditions

Irritable Bowel Syndrome With Constipation; Chronic Constipation

Outcome Measures

Primary Outcomes (1)

• Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)

  For RI and Phase 2 RO participants, an AE that occurred during the study was considered a TEAE if it was not present before the day of the first dose of open-label study drug, or was present before the day of the first dose of open-label study drug but increased in severity on or after that day. For Phase 3 RO participants, an AE that occurred during the study was considered a TEAE if it was not present before the day of the first dose of double-blind study drug in trial MCP-103-302 or MCP-103-303, or was present before the day of the first dose of double-blind study drug in those trials but increased in severity on or after that day. Deaths and serious AEs (SAEs) are those that occurred on or after the date of the first dose of open-label study drug, and within 30 days of the date of last dose of open-label study drug.

  From first dose of open-label study drug up to 78 weeks

Study Arms (1)

Linaclotide

EXPERIMENTAL

Linaclotide 290 μg/day capsules, administered orally once daily for up to 78 weeks. Dose reduction to 145 μg/day was permitted at the discretion of the Investigator.

Drug: Linaclotide

Interventions

Linaclotide DRUG

Linaclotide capsules, oral, once daily each morning at least 30 minutes before breakfast for the duration of the study.

Also known as: Linzess

Linaclotide

Eligibility Criteria

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

You may qualify if:

• Patients must have
• entered study MCP-103-303 or MCP-103-302 and at minimum completed the pre-treatment period or
• completed one of the following studies: MCP-103-004, MCP-103-005, MCP-103-201, MCP-103-202
• Sexually active patients of childbearing potential agree to use birth control
• Females of childbearing potential must have a negative urine pregnancy test prior to dosing
• Lactating females must agree not to breastfeed
• Patient must meet protocol criteria for CC or IBS-C

You may not qualify if:

• Patient must not use protocol-defined prohibited medicine
• Patient is planning to receive an investigational drug at any time during the study
• Patient has an unresolved adverse events or a clinically significant finding on a physical examination, 12-lead electrocardiogram, or clinical laboratory test

Sponsors & Collaborators

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

Study Sites (116)

Ironwood Investigational Site

Birmingham, Alabama, 35209, United States

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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, 85710, United States

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Tucson, Arizona, 85715, 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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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, 32205, United States

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Jacksonville, Florida, 32256, 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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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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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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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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Huntersville, North Carolina, 28078, 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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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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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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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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Sugar Land, 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

Location

MeSH Terms

Interventions

linaclotide

Results Point of Contact

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

(617) 621-7722

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2008
• First Posted: August 8, 2008
• Study Start: September 1, 2008
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: February 19, 2018
• Results First Posted: February 19, 2018

Record last verified: 2018-01

Locations

US (116)