Clinical trial NCT00730171: An Open-label, Long-term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation
Official title: An Open-label, Long-term Safety Study of Oral Linaclotide Administered to Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Irritable Bowel Syndrome With Constipation
Chronic Constipation
Lead sponsor: Ironwood Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Forest Laboratories
First posted: 2008-08-08
Enrollment: 1743
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)
timeFrame: From first dose of open-label study drug up to 78 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Ironwood Investigational Site
state: Alabama
city: Huntsville
country: United States
facility: Ironwood Investigational Site
state: Alabama
city: Chandler
country: United States
facility: Ironwood Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Ironwood Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Ironwood Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Ironwood Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Ironwood Investigational Site
state: Arizona
city: Sherwood
country: United States
facility: Ironwood Investigational Site
state: Arkansas
city: Anaheim
country: United States
facility: Ironwood Investigational Site
state: California
city: Chula Vista
country: United States
facility: Ironwood Investigational Site
state: California
city: Encinitas
country: United States
facility: Ironwood Investigational Site
state: California
city: Garden Grove
country: United States
facility: Ironwood Investigational Site
state: California
city: Laguna Hills
country: United States
facility: Ironwood Investigational Site
state: California
city: Los Angeles
country: United States
facility: Ironwood Investigational Site
state: California
city: Orange
country: United States
facility: Ironwood Investigational Site
state: California
city: Sacramento
country: United States
facility: Ironwood Investigational Site
state: California
city: San Carlos
country: United States
facility: Ironwood Investigational Site
state: California
city: San Diego
country: United States
facility: Ironwood Investigational Site
state: California
city: San Diego
country: United States
facility: Ironwood Investigational Site
state: California
city: San Diego
country: United States
facility: Ironwood Investigational Site
state: California
city: Colorado Springs
country: United States
facility: Ironwood Investigational Site
state: Colorado
city: Bristol
country: United States
facility: Ironwood Investigational Site
state: Connecticut
city: Boynton Beach
country: United States
facility: Ironwood Investigational Site
state: Florida
city: Hollywood
country: United States
facility: Ironwood Investigational Site
state: Florida
city: Inverness
country: United States
facility: Ironwood Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Ironwood Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Ironwood Investigational Site
state: Florida
city: Lauderdale Lakes
country: United States
facility: Ironwood Investigational Site
state: Florida
city: Miami
country: United States
facility: Ironwood Investigational Site
state: Florida
city: Pinellas Park
country: United States
facility: Ironwood Investigational Site
state: Florida
city: Port Orange
country: United States
facility: Ironwood Investigational Site
state: Florida
city: Tampa
country: United States
facility: Ironwood Investigational Site
state: Florida
city: Newnan
country: United States
facility: Ironwood Investigational Site
state: Georgia
city: Peoria
country: United States
facility: Ironwood Investigational Site
state: Illinois
city: Anderson
country: United States
facility: Ironwood Investigational Site
state: Indiana
city: Clive
country: United States
facility: Ironwood Investigational Site
state: Iowa
city: Davenport
country: United States
facility: Ironwood Investigational Site
state: Iowa
city: Mission
country: United States
facility: Ironwood Investigational Site
state: Kansas
city: Overland Park
country: United States
facility: Ironwood Investigational Site
state: Kansas
city: Topeka
country: United States
facility: Ironwood Investigational Site
state: Kansas
city: Baton Rouge
country: United States
facility: Ironwood Investigational Site
state: Louisiana
city: Metairie
country: United States
facility: Ironwood Investigational Site
state: Louisiana
city: Monroe
country: United States
facility: Ironwood Investigational Site
state: Louisiana
city: Shreveport
country: United States
facility: Ironwood Investigational Site
state: Louisiana
city: Annapolis
country: United States
facility: Ironwood Investigational Site
state: Maryland
city: Baltimore
country: United States
facility: Ironwood Investigational Site
state: Maryland
city: Hollywood
country: United States
facility: Ironwood Investigational Site
state: Maryland
city: Laurel
country: United States
facility: Ironwood Investigational Site
state: Maryland
city: Chesterfield
country: United States
facility: Ironwood Investigational Site
state: Michigan
city: Traverse City
country: United States
facility: Ironwood Investigational Site
state: Michigan
city: Troy
country: United States
facility: Ironwood Investigational Site
state: Michigan
city: Plymouth
country: United States
facility: Ironwood Investigational Site
state: Minnesota
city: Jackson
country: United States
facility: Ironwood Investigational Site
state: Mississippi
city: Tupelo
country: United States
facility: Ironwood Investigational Site
state: Mississippi
city: Jefferson City
country: United States
facility: Ironwood Investigational Site
state: Missouri
city: Henderson
country: United States
facility: Ironwood Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: Ironwood Investigational Site
state: Nevada
city: Cedar Knolls
country: United States
facility: Ironwood Investigational Site
state: New Jersey
city: Marlton
country: United States
facility: Ironwood Investigational Site
state: New Jersey
city: Ocean City
country: United States
facility: Ironwood Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: Ironwood Investigational Site
state: New Mexico
city: Mineola
country: United States
facility: Ironwood Investigational Site
state: New York
city: Pittsford
country: United States
facility: Ironwood Investigational Site
state: New York
city: Asheboro
country: United States
facility: Ironwood Investigational Site
state: North Carolina
city: Asheville
country: United States
facility: Ironwood Investigational Site
state: North Carolina
city: Chapel Hill
country: United States
facility: Ironwood Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: Ironwood Investigational Site
state: North Carolina
city: Greensboro
country: United States
facility: Ironwood Investigational Site
state: North Carolina
city: Harrisburg
country: United States
facility: Ironwood Investigational Site
state: North Carolina
city: Hickory
country: United States
facility: Ironwood Investigational Site
state: North Carolina
city: Huntersville
country: United States
facility: Ironwood Investigational Site
state: North Carolina
city: Jacksonville
country: United States
facility: Ironwood Investigational Site
state: North Carolina
city: New Bern
country: United States
facility: Ironwood Investigational Site
state: North Carolina
city: Statesville
country: United States
facility: Ironwood Investigational Site
state: North Carolina
city: Summerville
country: United States
facility: Ironwood Investigational Site
state: North Carolina
city: Wilmington
country: United States
facility: Ironwood Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Ironwood Investigational Site
state: North Carolina
city: Beachwood
country: United States
facility: Ironwood Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Ironwood Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Ironwood Investigational Site
state: Ohio
city: Dayton
country: United States
facility: Ironwood Investigational Site
state: Ohio
city: Mentor
country: United States
facility: Ironwood Investigational Site
state: Ohio
city: Sylvania
country: United States
facility: Ironwood Investigational Site
state: Ohio
city: Wadsworth
country: United States
facility: Ironwood Investigational Site
state: Ohio
city: Zanesville
country: United States
facility: Ironwood Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Ironwood Investigational Site
state: Oklahoma
city: Yukon
country: United States
facility: Ironwood Investigational Site
state: Oklahoma
city: Lancaster
country: United States
facility: Ironwood Investigational Site
state: Pennsylvania
city: Lancaster
country: United States
facility: Ironwood Investigational Site
state: Pennsylvania
city: Levittown
country: United States
facility: Ironwood Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Ironwood Investigational Site
state: Pennsylvania
city: Sellersville
country: United States
facility: Ironwood Investigational Site
state: Pennsylvania
city: Anderson
country: United States
facility: Ironwood Investigational Site
state: South Carolina
city: Charleston
country: United States
facility: Ironwood Investigational Site
state: South Carolina
city: Simpsonville
country: United States
facility: Ironwood Investigational Site
state: South Carolina
city: Bristol
country: United States
facility: Ironwood Investigational Site
state: Tennessee
city: Chattanooga
country: United States
facility: Ironwood Investigational Site
state: Tennessee
city: Germantown
country: United States
facility: Ironwood Investigational Site
state: Tennessee
city: Kingsport
country: United States
facility: Ironwood Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Ironwood Investigational Site
state: Tennessee
city: Beaumont
country: United States
facility: Ironwood Investigational Site
state: Texas
city: El Paso
country: United States
facility: Ironwood Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: Ironwood Investigational Site
state: Texas
city: Houston
country: United States
facility: Ironwood Investigational Site
state: Texas
city: Irving
country: United States
facility: Ironwood Investigational Site
state: Texas
city: Longview
country: United States
facility: Ironwood Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Ironwood Investigational Site
state: Texas
city: Sugar Land
country: United States
facility: Ironwood Investigational Site
state: Texas
city: Ogden
country: United States
facility: Ironwood Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: Ironwood Investigational Site
state: Utah
city: Chesapeake
country: United States
facility: Ironwood Investigational Site
state: Virginia
city: Lynchburg
country: United States
facility: Ironwood Investigational Site
state: Virginia
city: Spokane
country: United States
facility: Ironwood Investigational Site
state: Washington
city: Vancouver
country: United States
facility: Ironwood Investigational Site
state: Washington
city: La Crosse
country: United States
facility: Ironwood Investigational Site
state: Wisconsin
city: Milwaukee
country: United States
facility: Ironwood Investigational Site
state: Wisconsin
Study officials:
affiliation: Ironwood Pharmaceuticals, Inc.
name: Jeffrey M. Johnston, MD, FACP
role: STUDY_CHAIR
References: