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

Constipation Clinical Trial

Official title:

A Randomized, Multicenter, Double-Blind, Parallel-Design, Phase 2 Trial of Oral MD-1100 Acetate Administered for 14 Days Once Daily at 100 ug, 300 ug, 1000 ug, or Placebo to Patients With Chronic Constipation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00306748
• Other study ID #: MCP-103-004
• Status: Completed
• Phase: Phase 2
• First received: March 20, 2006
• Last updated: March 22, 2009
• Start date: March 2006
• Est. completion date: August 2006

Study information

• Verified date: March 2009
• Source: Ironwood Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation

Intervention

Drug:
• MD-1100 Acetate

Locations

Country	Name	City	State
United States	Austin Gastroenterology, P.A.	Austin	Texas
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Consultants for Clinical Research of South Florida	Boynton Beach	Florida
United States	UC for Functional GI & Motility Disorders	Chapel Hill	North Carolina
United States	ClinSearch	Chattanooga	Tennessee
United States	Trinity Clinic - Corsicana	Corsicana	Texas
United States	Memphis Gastroenterology Clinic	Germantown	Tennessee
United States	Vital Research	Greensboro	North Carolina
United States	Clinical Research Associates	Huntsville	Alabama
United States	Arkansas Gastroenterology	North Little Rock	Arkansas
United States	Sooner Clinical Research	Oklahoma City	Oklahoma
United States	Vantage Clinical Research	Olympia	Washington
United States	Chung H. Kim, MD	Pittsford	New York
United States	East Coast Clinical Research, LLC	Virginia Beach	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Ironwood Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety will be evaluated on an ongoing basis by completing physical examinations, ECGs, clinical laboratory tests, and adverse event reporting.
Secondary	Stool Frequency will be reported daily
Secondary	Stool Consistency (Bristol Stool Form Scale) will be reported daily
Secondary	Stool Ease of Passage will be reported daily
Secondary	Stool Completeness of Evacuation will be reported daily
Secondary	Patient Assessment of Abdominal Discomfort will be reported weekly
Secondary	Patient Assessment of Constipation will be reported weekly
Secondary	Patient Assessment of Overall Relief will be reported weekly
Secondary	Part 1 of the Irritable Bowel Symptom Severity Scale (IBSSS) will be reported once pre-dose and once post-dose.