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

This study has been completed.
Sponsor:
Information provided by:
Ironwood Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00306748
First received: March 20, 2006
Last updated: March 22, 2009
Last verified: March 2009
  Purpose

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.


Condition Intervention Phase
Constipation
Drug: MD-1100 Acetate
Phase 2

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

Resource links provided by NLM:


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

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

Secondary Outcome Measures:
  • 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
  • Patient Assessment of Constipation will be reported weekly
  • Patient Assessment of Overall Relief will be reported weekly
  • Part 1 of the Irritable Bowel Symptom Severity Scale (IBSSS) will be reported once pre-dose and once post-dose.

Estimated Enrollment: 40
Study Start Date: March 2006
Estimated Study Completion Date: August 2006
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00306748

Locations
United States, Alabama
Clinical Research Associates
Huntsville, Alabama, United States, 35801
United States, Arkansas
Arkansas Gastroenterology
North Little Rock, Arkansas, United States, 72117
United States, Florida
Consultants for Clinical Research of South Florida
Boynton Beach, Florida, United States, 33426
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, New York
Chung H. Kim, MD
Pittsford, New York, United States, 14534
United States, North Carolina
UC for Functional GI & Motility Disorders
Chapel Hill, North Carolina, United States, 27599-7080
Vital Research
Greensboro, North Carolina, United States, 27408
United States, Oklahoma
Sooner Clinical Research
Oklahoma City, Oklahoma, United States, 73112
United States, Tennessee
ClinSearch
Chattanooga, Tennessee, United States, 37304
Memphis Gastroenterology Clinic
Germantown, Tennessee, United States, 38120
United States, Texas
Austin Gastroenterology, P.A.
Austin, Texas, United States, 78745
Trinity Clinic - Corsicana
Corsicana, Texas, United States, 75110
United States, Virginia
East Coast Clinical Research, LLC
Virginia Beach, Virginia, United States, 23454
United States, Washington
Vantage Clinical Research
Olympia, Washington, United States, 98506
Sponsors and Collaborators
Ironwood Pharmaceuticals, Inc.
Investigators
Study Director: Jeffrey M. Johnston, MD, FACP Microbia, Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00306748     History of Changes
Other Study ID Numbers: MCP-103-004
Study First Received: March 20, 2006
Last Updated: March 22, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Ironwood Pharmaceuticals, Inc.:
Chronic Constipation
Chronic Idiopathic Constipation
Constipation
CIC
CC
MD-1100
MD-1100 Acetate
Microbia
Microbia, Inc.
linaclotide
linaclotide acetate

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on August 18, 2014