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

Chronic Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00730171
• Other study ID #: MCP-103-305
• Status: Completed
• Phase: Phase 3
• First received: August 5, 2008
• Last updated: January 19, 2018
• Start date: September 2008
• Est. completion date: March 2012

Study information

• Verified date: January 2018
• Source: Ironwood Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

Participants include randomization-ineligible (RI) patients from the lead-in double-blind trials MCP-103-302 (NCT00938717) or MCP-103-303 (NCT00730015), or rollover (RO) patients from the lead-in double-blind trials MCP-103-302 (NCT00938717), MCP-103-303 (NCT00730015), and from the Phase 2 double-blind studies MCP-103-004 (NCT00306748), MCP-103-005 (NCT00258193), and MCP-103-201 (NCT00402337), or MCP-103-202 (NCT00460811).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1743
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Chronic Constipation
• Constipation
• Irritable Bowel Syndrome
• Irritable Bowel Syndrome With Constipation
• Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	Ironwood Investigational Site	Albuquerque	New Mexico
United States	Ironwood Investigational Site	Anaheim	California
United States	Ironwood Investigational Site	Anderson	Indiana
United States	Ironwood Investigational Site	Anderson	South Carolina
United States	Ironwood Investigational Site	Annapolis	Maryland
United States	Ironwood Investigational Site	Asheboro	North Carolina
United States	Ironwood Investigational Site	Asheville	North Carolina
United States	Ironwood Investigational Site	Baltimore	Maryland
United States	Ironwood Investigational Site	Baton Rouge	Louisiana
United States	Ironwood Investigational Site	Beachwood	Ohio
United States	Ironwood Investigational Site	Beaumont	Texas
United States	Ironwood Investigational Site	Birmingham	Alabama
United States	Ironwood Investigational Site	Boynton Beach	Florida
United States	Ironwood Investigational Site	Bristol	Connecticut
United States	Ironwood Investigational Site	Bristol	Tennessee
United States	Ironwood Investigational Site	Cedar Knolls	New Jersey
United States	Ironwood Investigational Site	Chandler	Arizona
United States	Ironwood Investigational Site	Chapel Hill	North Carolina
United States	Ironwood Investigational Site	Charleston	South Carolina
United States	Ironwood Investigational Site	Charlotte	North Carolina
United States	Ironwood Investigational Site	Chattanooga	Tennessee
United States	Ironwood Investigational Site	Chesapeake	Virginia
United States	Ironwood Investigational Site	Chesterfield	Michigan
United States	Ironwood Investigational Site	Chula Vista	California
United States	Ironwood Investigational Site	Cincinnati	Ohio
United States	Ironwood Investigational Site	Cincinnati	Ohio
United States	Ironwood Investigational Site	Clive	Iowa
United States	Ironwood Investigational Site	Colorado Springs	Colorado
United States	Ironwood Investigational Site	Davenport	Iowa
United States	Ironwood Investigational Site	Dayton	Ohio
United States	Ironwood Investigational Site	El Paso	Texas
United States	Ironwood Investigational Site	Encinitas	California
United States	Ironwood Investigational Site	Fort Worth	Texas
United States	Ironwood Investigational Site	Garden Grove	California
United States	Ironwood Investigational Site	Germantown	Tennessee
United States	Ironwood Investigational Site	Greensboro	North Carolina
United States	Ironwood Investigational Site	Harrisburg	North Carolina
United States	Ironwood Investigational Site	Henderson	Nevada
United States	Ironwood Investigational Site	Hickory	North Carolina
United States	Ironwood Investigational Site	Hollywood	Maryland
United States	Ironwood Investigational Site	Hollywood	Florida
United States	Ironwood Investigational Site	Houston	Texas
United States	Ironwood Investigational Site	Huntersville	North Carolina
United States	Ironwood Investigational Site	Huntsville	Alabama
United States	Ironwood Investigational Site	Inverness	Florida
United States	Ironwood Investigational Site	Irving	Texas
United States	Ironwood Investigational Site	Jackson	Mississippi
United States	Ironwood Investigational Site	Jacksonville	North Carolina
United States	Ironwood Investigational Site	Jacksonville	Florida
United States	Ironwood Investigational Site	Jacksonville	Florida
United States	Ironwood Investigational Site	Jefferson City	Missouri
United States	Ironwood Investigational Site	Kingsport	Tennessee
United States	Ironwood Investigational Site	La Crosse	Wisconsin
United States	Ironwood Investigational Site	Laguna Hills	California
United States	Ironwood Investigational Site	Lancaster	Pennsylvania
United States	Ironwood Investigational Site	Lancaster	Pennsylvania
United States	Ironwood Investigational Site	Las Vegas	Nevada
United States	Ironwood Investigational Site	Lauderdale Lakes	Florida
United States	Ironwood Investigational Site	Laurel	Maryland
United States	Ironwood Investigational Site	Levittown	Pennsylvania
United States	Ironwood Investigational Site	Longview	Texas
United States	Ironwood Investigational Site	Los Angeles	California
United States	Ironwood Investigational Site	Lynchburg	Virginia
United States	Ironwood Investigational Site	Marlton	New Jersey
United States	Ironwood Investigational Site	Mentor	Ohio
United States	Ironwood Investigational Site	Metairie	Louisiana
United States	Ironwood Investigational Site	Miami	Florida
United States	Ironwood Investigational Site	Milwaukee	Wisconsin
United States	Ironwood Investigational Site	Mineola	New York
United States	Ironwood Investigational Site	Mission	Kansas
United States	Ironwood Investigational Site	Monroe	Louisiana
United States	Ironwood Investigational Site	Nashville	Tennessee
United States	Ironwood Investigational Site	New Bern	North Carolina
United States	Ironwood Investigational Site	Newnan	Georgia
United States	Ironwood Investigational Site	Ocean City	New Jersey
United States	Ironwood Investigational Site	Ogden	Utah
United States	Ironwood Investigational Site	Oklahoma City	Oklahoma
United States	Ironwood Investigational Site	Orange	California
United States	Ironwood Investigational Site	Overland Park	Kansas
United States	Ironwood Investigational Site	Peoria	Illinois
United States	Ironwood Investigational Site	Phoenix	Arizona
United States	Ironwood Investigational Site	Pinellas Park	Florida
United States	Ironwood Investigational Site	Pittsburgh	Pennsylvania
United States	Ironwood Investigational Site	Pittsford	New York
United States	Ironwood Investigational Site	Plymouth	Minnesota
United States	Ironwood Investigational Site	Port Orange	Florida
United States	Ironwood Investigational Site	Sacramento	California
United States	Ironwood Investigational Site	Salt Lake City	Utah
United States	Ironwood Investigational Site	San Antonio	Texas
United States	Ironwood Investigational Site	San Carlos	California
United States	Ironwood Investigational Site	San Diego	California
United States	Ironwood Investigational Site	San Diego	California
United States	Ironwood Investigational Site	San Diego	California
United States	Ironwood Investigational Site	Sellersville	Pennsylvania
United States	Ironwood Investigational Site	Sherwood	Arkansas
United States	Ironwood Investigational Site	Shreveport	Louisiana
United States	Ironwood Investigational Site	Simpsonville	South Carolina
United States	Ironwood Investigational Site	Spokane	Washington
United States	Ironwood Investigational Site	Statesville	North Carolina
United States	Ironwood Investigational Site	Sugar Land	Texas
United States	Ironwood Investigational Site	Summerville	North Carolina
United States	Ironwood Investigational Site	Sylvania	Ohio
United States	Ironwood Investigational Site	Tampa	Florida
United States	Ironwood Investigational Site	Topeka	Kansas
United States	Ironwood Investigational Site	Traverse City	Michigan
United States	Ironwood Investigational Site	Troy	Michigan
United States	Ironwood Investigational Site	Tucson	Arizona
United States	Ironwood Investigational Site	Tucson	Arizona
United States	Ironwood Investigational Site	Tucson	Arizona
United States	Ironwood Investigational Site	Tupelo	Mississippi
United States	Ironwood Investigational Site	Vancouver	Washington
United States	Ironwood Investigational Site	Wadsworth	Ohio
United States	Ironwood Investigational Site	Wilmington	North Carolina
United States	Ironwood Investigational Site	Winston-Salem	North Carolina
United States	Ironwood Investigational Site	Yukon	Oklahoma
United States	Ironwood Investigational Site	Zanesville	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ironwood Pharmaceuticals, Inc.	Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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