Dose-Range-Finding, Phase 2 Trial of Oral Linaclotide Acetate Administered to Patients With Chronic Constipation - Full Text View

Sponsored by:	Ironwood Pharmaceuticals, Inc.
Information provided by:	Ironwood Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00402337

Purpose

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

Condition	Intervention	Phase
Chronic Constipation	Drug: linaclotide acetate	Phase II

MedlinePlus related topics: Constipation

Drug Information available for: Linaclotide acetate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Ironwood Pharmaceuticals, Inc.:

Primary Outcome Measures:

Change in mean spontaneous bowel movement (SBM) frequency [ Time Frame: Weekly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Complete spontaneous bowel movement (CSBM) responder [ Time Frame: Weekly and study duration ] [ Designated as safety issue: No ]
Daily Bowel Habits (stool frequency, stool consistency, severity of straining, and completeness of evacuation) [ Time Frame: Collected daily for study duration ] [ Designated as safety issue: No ]
Daily Patient Symptom Severity Assessments: Abdominal discomfort, abdominal pain, and bloating [ Time Frame: Daily ] [ Designated as safety issue: No ]
Patient Assessment of Constipation Severity [ Time Frame: Weekly ] [ Designated as safety issue: No ]
Patient Global Assessment of Relief of Constipation Symptoms [ Time Frame: Weekly ] [ Designated as safety issue: No ]
Use of Rescue Medication [ Time Frame: Entire Study ] [ Designated as safety issue: No ]
End of Treatment Satisfaction [ Time Frame: Upon Completion of Treatment Period ] [ Designated as safety issue: No ]
Patient Assessment Constipation - Quality of Life (PAC-QOL) [ Time Frame: Beginning and End of Treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	November 2006
Study Completion Date:	February 2008
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
75 ug linaclotide acetate: Active Comparator	Drug: linaclotide acetate 75, 150, 300, 600 ug linaclotide acetate administered once daily for the duration of the study.
150 ug linaclotide acetate: Active Comparator	Drug: linaclotide acetate 75, 150, 300, 600 ug linaclotide acetate administered once daily for the duration of the study.
300 ug linaclotide acetate: Active Comparator	Drug: linaclotide acetate 75, 150, 300, 600 ug linaclotide acetate administered once daily for the duration of the study.
600 ug linaclotide acetate: Active Comparator	Drug: linaclotide acetate 75, 150, 300, 600 ug linaclotide acetate administered once daily for the duration of the study.
Matching Placebo: Placebo Comparator	Drug: linaclotide acetate 75, 150, 300, 600 ug linaclotide acetate administered once daily for the duration of the study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00402337

Show 62 Study Locations

Sponsors and Collaborators

Ironwood Pharmaceuticals, Inc.

Investigators

Study Director:

Microbia Medical Affairs

Microbia, Inc.

More Information

Responsible Party:	Microbia, Inc. ( Chief Medical Officer and Vice President, Clinical, Biometric, and Regulatory Affairs )
Study ID Numbers:	MCP-103-201
Study First Received:	November 18, 2006
Last Updated:	May 14, 2008
ClinicalTrials.gov Identifier:	NCT00402337
Health Authority:	United States: Food and Drug Administration

Keywords provided by Ironwood Pharmaceuticals, Inc.:

Constipation
Chronic Constipation
Microbia

linaclotide
linaclotide acetate
MD-1100

Study placed in the following topic categories:

Signs and Symptoms
Signs and Symptoms, Digestive
Constipation

ClinicalTrials.gov processed this record on January 14, 2009