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

NCT ID: NCT00402337

Last Updated: 2013-03-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

310 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2008-02-29

Brief Summary

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

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Detailed Description

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Conditions

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Chronic Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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72 ug linaclotide acetate

Group Type ACTIVE_COMPARATOR

linaclotide acetate

Intervention Type DRUG

oral, once daily.

145 ug linaclotide acetate

Group Type ACTIVE_COMPARATOR

linaclotide acetate

Intervention Type DRUG

oral, once daily.

290 ug linaclotide acetate

Group Type ACTIVE_COMPARATOR

linaclotide acetate

Intervention Type DRUG

oral, once daily.

579 ug linaclotide acetate

Group Type ACTIVE_COMPARATOR

linaclotide acetate

Intervention Type DRUG

oral, once daily.

Matching Placebo

Group Type PLACEBO_COMPARATOR

Matching placebo

Intervention Type DRUG

oral, once daily

Interventions

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linaclotide acetate

oral, once daily.

Intervention Type DRUG

Matching placebo

oral, once daily

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ironwood Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Microbia Medical Affairs

Role: STUDY_DIRECTOR

Microbia, Inc.

Locations

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Microbia Investigational Site

Huntsville, Alabama, United States

Site Status

Microbia Investigational Site

Tucson, Arizona, United States

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Sherwood, Arkansas, United States

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Anaheim, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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Boulder, Colorado, United States

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Bristol, Connecticut, United States

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Boynton Beach, Florida, United States

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Port Orange, Florida, United States

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Tampa, Florida, United States

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Stockbridge, Georgia, United States

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Peoria, Illinois, United States

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Indianapolis, Indiana, United States

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Clive, Iowa, United States

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Davenport, Iowa, United States

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Louisville, Kentucky, United States

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Monroe, Louisiana, United States

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Silver Spring, Maryland, United States

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Boston, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Traverse City, Michigan, United States

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Olive Branch, Mississippi, United States

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Lincoln, Nebraska, United States

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Great Neck, New York, United States

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Pittsford, New York, United States

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Asheville, North Carolina, United States

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Chapel Hill, North Carolina, United States

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Charlotte, North Carolina, United States

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Fayetteville, North Carolina, United States

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Greensboro, North Carolina, United States

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Raleigh, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Dayton, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Pittsburgh, Pennsylvania, United States

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Sellersville, Pennsylvania, United States

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Anderson, South Carolina, United States

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Columbia, South Carolina, United States

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Simpsonville, South Carolina, United States

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Summerville, South Carolina, United States

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Bristol, Tennessee, United States

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Chattanooga, Tennessee, United States

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Germantown, Tennessee, United States

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Jackson, Tennessee, United States

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Austin, Texas, United States

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Corsicana, Texas, United States

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El Paso, Texas, United States

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San Antonio, Texas, United States

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Ogden, Utah, United States

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Chesapeake, Virginia, United States

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Microbia Investigational Site

Lynchburg, Virginia, United States

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Microbia Investigational Site

Olympia, Washington, United States

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Microbia Investigational Site

Spokane, Washington, United States

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Microbia Investigational Site

La Crosse, Wisconsin, United States

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Microbia Investigational Site

Madison, Wisconsin, United States

Site Status

Countries

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United States

References

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Lembo AJ, Kurtz CB, Macdougall JE, Lavins BJ, Currie MG, Fitch DA, Jeglinski BI, Johnston JM. Efficacy of linaclotide for patients with chronic constipation. Gastroenterology. 2010 Mar;138(3):886-95.e1. doi: 10.1053/j.gastro.2009.12.050. Epub 2010 Jan 4.

Reference Type DERIVED
PMID: 20045700 (View on PubMed)

Other Identifiers

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MCP-103-201

Identifier Type: -

Identifier Source: org_study_id

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