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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00306748
Recruitment Status : Completed
First Posted : March 24, 2006
Last Update Posted : March 24, 2009
Information provided by:
Ironwood Pharmaceuticals, Inc.

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.

Condition or disease Intervention/treatment Phase
Constipation Drug: MD-1100 Acetate Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : March 2006
Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

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

Secondary Outcome Measures :
  1. Stool Frequency will be reported daily
  2. Stool Consistency (Bristol Stool Form Scale) will be reported daily
  3. Stool Ease of Passage will be reported daily
  4. Stool Completeness of Evacuation will be reported daily
  5. Patient Assessment of Abdominal Discomfort will be reported weekly
  6. Patient Assessment of Constipation will be reported weekly
  7. Patient Assessment of Overall Relief will be reported weekly
  8. Part 1 of the Irritable Bowel Symptom Severity Scale (IBSSS) will be reported once pre-dose and once post-dose.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00306748

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
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.
Study Director: Jeffrey M. Johnston, MD, FACP Microbia, Inc. Identifier: NCT00306748     History of Changes
Other Study ID Numbers: MCP-103-004
First Posted: March 24, 2006    Key Record Dates
Last Update Posted: March 24, 2009
Last Verified: March 2009

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

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