Current partner codePEPTIDESDE
NCT00306748·Phase 2·INTERVENTIONAL

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

Status

Completed

Phase

Phase 2

Enrollment

40

Locations

14

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

MD-1100 Acetate

Timeline

From registration to results.

  1. First posted

    Mar 24, 2006

  2. Study start

    Mar 2006

  3. Primary completion

    Not reported

  4. Study completion

    Aug 2006

  5. Results posted

    Not reported

  6. Registry updated

    Mar 24, 2009

Outcomes

What the study measures.

Primary outcomes

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

Secondary outcomes

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.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
70 Years
Sex
ALL
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.

Study locations

14 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Clinical Research Associates

Huntsville, Alabama, United States

Arkansas Gastroenterology

North Little Rock, Arkansas, United States

Consultants for Clinical Research of South Florida

Boynton Beach, Florida, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Chung H. Kim, MD

Pittsford, New York, United States

UC for Functional GI & Motility Disorders

Chapel Hill, North Carolina, United States

Vital Research

Greensboro, North Carolina, United States

Sooner Clinical Research

Oklahoma City, Oklahoma, United States

ClinSearch

Chattanooga, Tennessee, United States

Memphis Gastroenterology Clinic

Germantown, Tennessee, United States

Austin Gastroenterology, P.A.

Austin, Texas, United States

Trinity Clinic - Corsicana

Corsicana, Texas, United States

East Coast Clinical Research, LLC

Virginia Beach, Virginia, United States

Vantage Clinical Research

Olympia, Washington, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Linaclotide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.