Clinical trial NCT00306748: Phase 2 Study of MD-1100 Acetate Administered for 14 Days to Patients Meeting Criteria for Chronic Constipation
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Constipation
Keywords: Chronic Constipation
Chronic Idiopathic Constipation
Constipation
CIC
CC
MD-1100
MD-1100 Acetate
Microbia
Microbia, Inc.
linaclotide
linaclotide acetate
Lead sponsor: Ironwood Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2006-03-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Safety will be evaluated on an ongoing basis by completing physical examinations, ECGs, clinical laboratory tests, and adverse event reporting.
Secondary outcomes:
measure: Stool Frequency will be reported daily
measure: Stool Consistency (Bristol Stool Form Scale) will be reported daily
measure: Stool Ease of Passage will be reported daily
measure: Stool Completeness of Evacuation will be reported daily
measure: Patient Assessment of Abdominal Discomfort will be reported weekly
measure: Patient Assessment of Constipation will be reported weekly
measure: Patient Assessment of Overall Relief will be reported weekly
measure: Part 1 of the Irritable Bowel Symptom Severity Scale (IBSSS) will be reported once pre-dose and once post-dose.
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Clinical Research Associates
state: Alabama
city: North Little Rock
country: United States
facility: Arkansas Gastroenterology
state: Arkansas
city: Boynton Beach
country: United States
facility: Consultants for Clinical Research of South Florida
state: Florida
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Pittsford
country: United States
facility: Chung H. Kim, MD
state: New York
city: Chapel Hill
country: United States
facility: UC for Functional GI & Motility Disorders
state: North Carolina
city: Greensboro
country: United States
facility: Vital Research
state: North Carolina
city: Oklahoma City
country: United States
facility: Sooner Clinical Research
state: Oklahoma
city: Chattanooga
country: United States
facility: ClinSearch
state: Tennessee
city: Germantown
country: United States
facility: Memphis Gastroenterology Clinic
state: Tennessee
city: Austin
country: United States
facility: Austin Gastroenterology, P.A.
state: Texas
city: Corsicana
country: United States
facility: Trinity Clinic - Corsicana
state: Texas
city: Virginia Beach
country: United States
facility: East Coast Clinical Research, LLC
state: Virginia
city: Olympia
country: United States
facility: Vantage Clinical Research
state: Washington
Study officials:
affiliation: Microbia, Inc.
name: Jeffrey M. Johnston, MD, FACP
role: STUDY_DIRECTOR
References: