Phase 2 Study of MD-1100 Acetate Administered for 14 Days to Patients Meeting Criteria for Chronic Constipation

NCT00306748 | Completed Phase 2

• 1 other identifier: MCP-103-004
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 14

Brief Summary

The purpose of this study is to determine the safety and gastrointestinal pharmacodynamics (stool frequency, stool consistency, stool ease of passage, stool completeness of evacuation) of MD-1100 acetate administered daily for 14 days.

Conditions

Constipation

Keywords

Chronic Constipation; Chronic Idiopathic Constipation; Constipation; CIC; CC; MD-1100; MD-1100 Acetate; Microbia; Microbia, Inc.; linaclotide; linaclotide acetate

Outcome Measures

Primary Outcomes (1)

• Safety will be evaluated on an ongoing basis by completing physical examinations, ECGs, clinical laboratory tests, and adverse event reporting.

Secondary Outcomes (8)

• Stool Frequency will be reported daily

• Stool Consistency (Bristol Stool Form Scale) will be reported daily

• Stool Ease of Passage will be reported daily

• Stool Completeness of Evacuation will be reported daily

• Patient Assessment of Abdominal Discomfort will be reported weekly

Interventions

MD-1100 Acetate DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or non-pregnant, non-breastfeeding female, age 18-70 years old at the time of first dose;
• Sexually active patients of childbearing potential agree to use double-barrier birth control;
• Females of childbearing potential must complete negative pregnancy tests prior to first dose;
• Negative colonoscopy within 10 years or completion of negative flexible sigmoidoscopy if under the age of 50 provided there is no history of rectal bleeding, weight loss, or anemia;
• BMI must be greater than/equal to 18.5 and less than 35.0;
• Successful completion of physical exam, 12-lead ECG, clinical laboratory tests prior to first dose of study medication;
• Vital signs must not have clinically-significant findings within 4 hours of first dose of study medication;
• Patient reports 3 or less spontaneous bowel movements (SBMs) per week and meets 1 or more of the following criteria for constipation for 12 weeks in the previous 12 months: straining at least 25% bowel movements (BMs), lumpy or hard stools at least 25% of BMs, or sensation of incomplete evacuation at least 25% of BMs;
• Patient reports 3 or less SBMs during the 7-day Pre-treatment Period;
• Patient is compliant with IVRS for at least 6 days in the 7-day Pre-treatment Period.

You may not qualify if:

• Use of investigational drug within 30 days;
• Laxative/enema-induced diarrhea within 60 days;
• Patient meets ROME II criteria for functional diarrhea;
• Most bothersome symptom is moderate or severe abdominal pain or abdominal discomfort;
• History of cancer, inflammatory bowel disease, ischemic colitis, bowel resection, colostomy, or fecal impaction;
• Diagnosis of cathartic colon or laxative/enema abuse, pelvic floor dysfunction, evacuation disorder, bulimia, anorexia, or neurological disorders;
• Surgery within 30 days or GI surgery within 6 months of first dose of study medication. Cholecystectomy and/or appendectomy are acceptable if completed more than 60 days prior to first dose of study medication;
• Patient may not use any disallowed medications (prescription and/or over-the-counter treatments for chronic constipation or C-IBS, drugs that target 5-HT4, 5-HT2b, or 5-HT3 receptors, narcotics, anti-cholinergic agents, GI preparations, etc.) during the 7-day Pre-treatment Period or during the study. Stable, continuous (30 days or more) use of dietary fiber is acceptable.
• Any acute or chronic condition that would limit the patient's ability to complete and/or participate in the study.

Sponsors & Collaborators

• Ironwood Pharmaceuticals, Inc.: lead

Study Sites (14)

Clinical Research Associates

Huntsville, Alabama, 35801, United States

Location

Arkansas Gastroenterology

North Little Rock, Arkansas, 72117, United States

Location

Consultants for Clinical Research of South Florida

Boynton Beach, Florida, 33426, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Chung H. Kim, MD

Pittsford, New York, 14534, United States

Location

UC for Functional GI & Motility Disorders

Chapel Hill, North Carolina, 27599-7080, United States

Location

Vital Research

Greensboro, North Carolina, 27408, United States

Location

Sooner Clinical Research

Oklahoma City, Oklahoma, 73112, United States

Location

ClinSearch

Chattanooga, Tennessee, 37304, United States

Location

Memphis Gastroenterology Clinic

Germantown, Tennessee, 38120, United States

Location

Austin Gastroenterology, P.A.

Austin, Texas, 78745, United States

Location

Trinity Clinic - Corsicana

Corsicana, Texas, 75110, United States

Location

East Coast Clinical Research, LLC

Virginia Beach, Virginia, 23454, United States

Location

Vantage Clinical Research

Olympia, Washington, 98506, United States

Location

MeSH Terms

Conditions

Constipation

Interventions

linaclotide

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeffrey M. Johnston, MD, FACP

  Microbia, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 20, 2006
• First Posted: March 24, 2006
• Study Start: March 1, 2006
• Study Completion: August 1, 2006
• Last Updated: March 24, 2009

Record last verified: 2009-03

Locations

US (14)