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Clinical Trials/NCT00402337
NCT00402337CompletedPhase 2

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 enrollmentStarted: November 2006Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
310
Locations
1
Primary Endpoint
Change From Pretreatment in Weekly Normalized Spontaneous Bowel Movement (SBM) Frequency
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Active Comparator

Intervention: linaclotide acetate (Drug)

145 ug linaclotide acetate

Active Comparator

Intervention: linaclotide acetate (Drug)

290 ug linaclotide acetate

Active Comparator

Intervention: linaclotide acetate (Drug)

579 ug linaclotide acetate

Active Comparator

Intervention: linaclotide acetate (Drug)

Matching Placebo

Placebo Comparator

Intervention: Matching placebo (Drug)

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)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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