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

Ironwood Pharmaceuticals, Inc.1 site in 1 country310 target enrollmentNovember 2006

ConditionsChronic Constipation

Interventionslinaclotide acetate Matching placebo

Drugslinaclotide acetate Matching placebo

Overview

Phase: Phase 2
Intervention: linaclotide acetate
Conditions: Chronic Constipation
Sponsor: Ironwood Pharmaceuticals, Inc.
Enrollment: 310
Locations: 1
Primary Endpoint: Change From Pretreatment in Weekly Normalized Spontaneous Bowel Movement (SBM) Frequency
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The primary purpose of this study is to evaluate the efficacy and safety of administration of linaclotide acetate in patients with chronic constipation.

Registry

clinicaltrials.gov

Start Date

November 2006

End Date

February 2008

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ironwood Pharmaceuticals, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

72 ug linaclotide acetate

Intervention: linaclotide acetate

145 ug linaclotide acetate

Intervention: linaclotide acetate

290 ug linaclotide acetate

Intervention: linaclotide acetate

579 ug linaclotide acetate

Intervention: linaclotide acetate

Matching Placebo

Intervention: Matching placebo

Outcomes

Primary Outcomes

Change From Pretreatment in Weekly Normalized Spontaneous Bowel Movement (SBM) Frequency

Time Frame: Change from Baseline to Week 4

Change in SBM frequency during Weeks 1 through 4 of the treatment period from the weekly SBM rate obtained during the pretreatment period.

Secondary Outcomes

SBM 75% Responder for the Treatment Period (Based on the Normalized Rate)(Change from Baseline to Week 4)
CSBM 75% Responder for the Treatment Period (Based on the Normalized Rate)(Change from Baseline to Week 4)
Change From Baseline in the Weekly Normalized CSBM Rate for the Treatment Period(Change from Baseline to Week 4)
Change From Baseline in Stool Consistency (BSFS) Score for the Treatment Period(Change from Baseline to Week 4)
Change From Baseline in Straining Score for the Treatment Period(Change from Baseline to Week 4)