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

Irritable Bowel Syndrome With Constipation Clinical Trial

Official title:

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial of Linaclotide Administered Orally for 26 Weeks in Patients With Irritable Bowel Syndrome With Constipation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00938717
• Other study ID #: MCP-103-302
• Status: Completed
• Phase: Phase 3
• First received: July 12, 2009
• Last updated: October 9, 2013
• Start date: July 2009
• Est. completion date: September 2010

Study information

• Verified date: October 2013
• Source: Ironwood Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 805
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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

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	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	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	Greensboro	North Carolina
United States	Ironwood Investigational Site	Harrisburg	North Carolina
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	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	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	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	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	Pittsford	New York
United States	Ironwood Investigational Site	Plymouth	Minnesota
United States	Ironwood Investigational Site	Reading	Pennsylvania
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	Sugarland	Texas
United States	Ironwood Investigational Site	Summerville	South Carolina
United States	Ironwood Investigational Site	Sylvania	Ohio
United States	Ironwood Investigational Site	Tampa	Florida
United States	Ironwood Investigational Site	Tempe	Arizona
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	Tupelo	Mississippi
United States	Ironwood Investigational Site	Vancouver	Washington
United States	Ironwood Investigational Site	Wadsworth	Ohio
United States	Ironwood Investigational Site	Washington	Pennsylvania
United States	Ironwood Investigational Site	Winston-Salem	North Carolina
United States	Ironwood Investigational Site	Yukon	Oklahoma

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	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	12-Week Complete Spontaneous Bowel Movement (CSBM) Frequency	The change from baseline in 12-week CSBM frequency (i.e., weekly CSBM frequency over the first 12 weeks of the Treatment Period).	Change from Baseline to Week 12	No
Secondary	12-Week Spontaneous Bowl Movement (SBM) Frequency	The change from baseline in 12-week SBM frequency (i.e., weekly SBM frequency over the first 12 weeks of the Treatment Period).	Change from Baseline to Week 12	No
Secondary	12-Week Change in Stool Consistency	The consistency of each BM was assessed by patients using the 7-point Bristol Stool Form Scale (BSFS) from 1 to 7.; = separate hard lumps like nuts [difficult to pass]; = sausage shaped but lumpy; = like a sausage but with cracks on surface; = like a sausage or snake, smooth and soft; = soft blobs with clear-cut edges [passed easily]; = fluffy pieces with ragged edges, a mushy stool; = watery, no solid pieces [entirely liquid]).	Change from Baseline to Week 12	No
Secondary	12-Week Change in Severity of Straining	Straining is measured on a 5-point scale where a value of 1 is "not at all" and a value of 5 is "an extreme amount".	Change from Baseline to Week 12	No
Secondary	12-Week Change in Abdominal Pain Score	Abdominal Pain at its worst (in the last 24 hours) is based on an 11-point scale where 0 represents no abdominal pain and 10 represents very severe abdominal pain.	Change from Baseline to Week 12	No
Secondary	12-Week Change in Abdominal Discomfort	Abdominal discomfort was assessed on an 11-point scale where a value of 0 is "none" and a value of 10 is "very severe".	Change from Baseline to Week 12	No
Secondary	12-Week Change in Bloating	Bloating was assessed on an 11-point scale where a value of 0 is "none" and a value of 10 is "very severe".	Change from Baseline to Week 12	No
Secondary	Complete Spontaneous Bowl Movement (CSBM) Responder for 6 Weeks Out of 12 Weeks of Treatment	A patient is considered to be a CSBM responder if, for at least 6 out of the 12 weeks of the treatment period, an increase of at least 1 CSBM per week from baseline was experienced.	Change from Baseline to Week 12	No
Secondary	Abdominal Pain Responder for 6 Out of 12 Weeks	A patient is considered to be an AP responder if, for at least 6 out of the first 12 weeks of the treatment period, the patient had a decrease of at least 30 percent in their Abdominal Pain score from baseline during a particular week.	Change from Baseline to Week 12	No
Secondary	12-Week Percent of Abdominal Pain-free Days	Abdominal pain free (APF) days are those days where the patient reported a score of '0' for abdominal pain at its worst.; Abdominal Pain at its worst (in the last 24 hours) is based on an 11-point scale where 0 represents no abdominal pain and 10 represents very severe abdominal pain.	Change from Baseline to Week 12	No