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

This study has been completed.

Sponsored by: Ironwood Pharmaceuticals, Inc.
Information provided by: Ironwood Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00306748
  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 II

MedlinePlus related topics:   Constipation   

ChemIDplus related topics:   Linaclotide acetate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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

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
Vital Research    
      Greensboro, North Carolina, United States, 27408
UC for Functional GI & Motility Disorders    
      Chapel Hill, North Carolina, United States, 27599-7080
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

Study ID Numbers:   MCP-103-004
First Received:   March 20, 2006
Last Updated:   February 6, 2008
ClinicalTrials.gov Identifier:   NCT00306748
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

Study placed in the following topic categories:
Signs and Symptoms
Signs and Symptoms, Digestive
Constipation

ClinicalTrials.gov processed this record on September 05, 2008




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