Dose-range-finding, Phase 2 Trial of Oral Linaclotide Acetate Administered to Patients With Chronic Constipation

Chronic Constipation Clinical Trial

Official title:

A Randomized, Multicenter, Double-blind, Placebo-controlled, Dose-range-finding, Parallel-group, Phase 2 Trial of Oral Linaclotide Acetate Administered to Patients With Chronic Constipation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00402337
• Other study ID #: MCP-103-201
• Status: Completed
• Phase: Phase 2
• First received: November 18, 2006
• Last updated: January 29, 2013
• Start date: November 2006
• Est. completion date: February 2008

Study information

• Verified date: January 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 primary purpose of this study is to evaluate the efficacy and safety of administration of linaclotide acetate in patients with chronic constipation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 310
• Est. completion date: February 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient is 18 years of age or older

• Patient meets colonoscopy requirements according to the American Gastroenterological Association

• Patient meets criteria for chronic constipation including weekly bowel movement frequency requirements and reports one or more symptoms of constipation according to protocol requirements

• Patient has successfully completed study requirements with no clinically-significant findings: physical exam, ECG, clinical laboratory tests

• Patient is fluent in English

Exclusion Criteria:

• Patient reports loose or watery stools

• Patient meets criteria for IBS including protocol-defined abdominal discomfort or pain

• Patient may not take prohibited medications per protocol

• Medical diagnoses, medical conditions, or family history that would not make the patient a good candidate for the study or limit the patient's ability to complete the clinical study

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

• Chronic Constipation
• Constipation

Intervention

Drug:
• linaclotide acetate
oral, once daily.
• Matching placebo
oral, once daily

Locations

Country	Name	City	State
United States	Microbia Investigational Site	Anaheim	California
United States	Microbia Investigational Site	Anderson	South Carolina
United States	Microbia Investigational Site	Ann Arbor	Michigan
United States	Microbia Investigational Site	Asheville	North Carolina
United States	Microbia Investigational Site	Austin	Texas
United States	Microbia Investigational Site	Boston	Massachusetts
United States	Microbia Investigational Site	Boulder	Colorado
United States	Microbia Investigational Site	Boynton Beach	Florida
United States	Microbia Investigational Site	Bristol	Connecticut
United States	Microbia Investigational Site	Bristol	Tennessee
United States	Microbia Investigational Site	Chapel Hill	North Carolina
United States	Microbia Investigational Site	Charlotte	North Carolina
United States	Microbia Investigational Site	Chattanooga	Tennessee
United States	Microbia Investigational Site	Chesapeake	Virginia
United States	Microbia Investigational Site	Cincinnati	Ohio
United States	Microbia Investigational Site	Clive	Iowa
United States	Microbia Investigational Site	Columbia	South Carolina
United States	Microbia Investigational Site	Corsicana	Texas
United States	Microbia Investigational Site	Davenport	Iowa
United States	Microbia Investigational Site	Dayton	Ohio
United States	Microbia Investigational Site	El Paso	Texas
United States	Microbia Investigational Site	Fayetteville	North Carolina
United States	Microbia Investigational Site	Germantown	Tennessee
United States	Microbia Investigational Site	Great Neck	New York
United States	Microbia Investigational Site	Greensboro	North Carolina
United States	Microbia Investigational Site	Huntsville	Alabama
United States	Microbia Investigational Site	Indianapolis	Indiana
United States	Microbia Investigational Site	Jackson	Tennessee
United States	Microbia Investigational Site	La Crosse	Wisconsin
United States	Microbia Investigational Site	Lincoln	Nebraska
United States	Microbia Investigational Site	Louisville	Kentucky
United States	Microbia Investigational Site	Lynchburg	Virginia
United States	Microbia Investigational Site	Madison	Wisconsin
United States	Microbia Investigational Site	Monroe	Louisiana
United States	Microbia Investigational Site	Ogden	Utah
United States	Microbia Investigational Site	Oklahoma City	Oklahoma
United States	Microbia Investigational Site	Oklahoma City	Oklahoma
United States	Microbia Investigational Site	Oklahoma City	Oklahoma
United States	Microbia Investigational Site	Olive Branch	Mississippi
United States	Microbia Investigational Site	Olympia	Washington
United States	Microbia Investigational Site	Peoria	Illinois
United States	Microbia Investigational Site	Pittsburgh	Pennsylvania
United States	Microbia Investigational Site	Pittsford	New York
United States	Microbia Investigational Site	Port Orange	Florida
United States	Microbia Investigational Site	Raleigh	North Carolina
United States	Microbia Investigational Site	Sacramento	California
United States	Microbia Investigational Site	San Antonio	Texas
United States	Microbia Investigational Site	San Diego	California
United States	Microbia Investigational Site	Sellersville	Pennsylvania
United States	Microbia Investigational Site	Sherwood	Arkansas
United States	Microbia Investigational Site	Silver Spring	Maryland
United States	Microbia Investigational Site	Simpsonville	South Carolina
United States	Microbia Investigational Site	Spokane	Washington
United States	Microbia Investigational Site	Stockbridge	Georgia
United States	Microbia Investigational Site	Summerville	South Carolina
United States	Microbia Investigational Site	Tampa	Florida
United States	Microbia Investigational Site	Traverse City	Michigan
United States	Microbia Investigational Site	Tucson	Arizona
United States	Microbia Investigational Site	Tulsa	Oklahoma
United States	Microbia Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Ironwood Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Pretreatment in Weekly Normalized Spontaneous Bowel Movement (SBM) Frequency	Change in SBM frequency during Weeks 1 through 4 of the treatment period from the weekly SBM rate obtained during the pretreatment period.	Change from Baseline to Week 4	No
Secondary	SBM 75% Responder for the Treatment Period (Based on the Normalized Rate)	A patient was an SBM 75% Responder if the patient was an SBM Responder for =3 of the 4 treatment period weeks.; For each week of the treatment and postreatment periods, a patient was considered an SBM Responder if for that week the patient 1) completed =4 days of IVRS questions,2) had an SBM rate of = 3 for the week, and 3) had an increase in SBM rate of = 1 from their baseline weekly SBM rate.	Change from Baseline to Week 4	No
Secondary	CSBM 75% Responder for the Treatment Period (Based on the Normalized Rate)	A patient was a complete spontaneous bowel movement (CSBM) 75% Responder if the patient was a CSBM Responder for =3 of the 4 treatment period weeks.; For each week of the treatment and postreatment periods, a patient was considered a CSBM Responder if for that week the patient 1) completed =4 days of IVRS questions,2) had a CSBM rate of = 3 for the week, and 3) had an increase in CSBM rate of = 1 from their baseline weekly CSBM rate.	Change from Baseline to Week 4	No
Secondary	Change From Baseline in the Weekly Normalized CSBM Rate for the Treatment Period	CSBMs measured daily during the treatment period. During each daily phone call into the IVRS, patients were asked: How many bowel movements did you have today or yesterday after your last call?	Change from Baseline to Week 4	No
Secondary	Change From Baseline in Stool Consistency (BSFS) Score for the Treatment Period	Stool consistency analyses were performed using the 7-point BSFS, whereby a score of 1 = difficult to pass; 2 = sausage shaped but lumpy; 3 = like a sausage but with cracks on surface; 4 = like a sausage or snake, smooth and soft; 5 = soft blobs with clear-cut edges (passed easily); 6 = fluffy pieces with ragged edges, a mushy stool; and 7 = entirely liquid.	Change from Baseline to Week 4	No
Secondary	Change From Baseline in Straining Score for the Treatment Period	Straining was assessed using a 5-point ordinal scale, whereby a score of 1 = not at all, 2 = a little bit, 3 = a moderate amount, 4 = a great deal, and 5 = an extreme amount.	Change from Baseline to Week 4	No