Clinical trial NCT01257477: LOTRONEX® in Severe Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)
Official title: Research Study to Evaluate LOTRONEX® in Severe IBS-D: Analysis of Current Clinical Practice Environment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Irritable Bowel Syndrome
Keywords: Diarrhea
IBS
Irritable Bowel Syndrome
Lead sponsor: Prometheus Laboratories
Sponsor class: INDUSTRY
First posted: 2010-12-09
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women ≥ 18 years of age with severe diarrhea-predominant IBS, who have chronic IBS symptoms lasting 6 months or longer and who have not responded adequately to other IBS therapy will be eligible to enroll in the study.

Brief summary: An observational study to evaluate LOTRONEX® in women with severe IBS-D in the current clinical practice setting.

Detailed description: This observational study will evaluate the effect of Lotronex® as used in the current clinical practice setting on symptom relief, specifically, improvement in bowel habits and IBS pain. Patients planning to initiate commercially available LOTRONEX® therapy will be consented for study participation. Patients will complete study questionnaires related to bowel symptoms, prior therapies, quality of life, productivity loss and treatment outcome. Investigators will also be asked to complete questionnaires related to the patient's disease characteristics, patient progress on study medication and treatment outcome.

Eligibility criteria: Inclusion Criteria:

1. Be a female between 18 and 65 years of age (inclusive) at Visit 1.
2. Sign and date a written informed consent form prior to the initiation of any study-related activities, including discontinuation of any prohibited medications.
3. Be diagnosed with severe, diarrhea-predominant IBS.
4. Have experienced chronic IBS symptoms lasting 6 months or longer.
5. Have not responded adequately to other IBS therapy.
6. Be able to read, understand and sign the informed consent and, if applicable, an Authorization to Use and Disclose Protected Health Information form (consistent with Health Insurance Portability and Accountability Act of 1996 \[HIPAA\] legislation), answer the study questionnaires, communicate with the investigator, and understand and comply with protocol requirements.

Exclusion Criteria:

1. Has had a period of 3 consecutive days without a bowel movement in the past 14 days.
2. In the past 14 days, has had evidence of chronic or severe constipation, or has a history of chronic or severe constipation, or a history of sequelae from constipation.
3. Has recurrent bowel obstruction of the small intestine or colon.
4. Has had bloody diarrhea or abdominal pain with rectal bleeding in the past 14 days (except rectal bleeding due to hemorrhoids).
5. Has a known biochemical or anatomical abnormality of the gastrointestinal tract.
6. Has a history of thrombophlebitis or hypercoagulable state.
7. Has a history of atherosclerosis.
8. Has any medical or surgical condition that in the judgment of the investigator makes the patient an inappropriate candidate for Lotronex® therapy (e.g., an unstable cardiovascular, autoimmune, renal, hepatic, pulmonary, endocrine, metabolic, gastrointestinal, hematologic, or neurological condition; recent or ongoing malignancy; evidence of hepatic dysfunction; or renal impairment.)
9. Mental impairment of inability to understand the medication guide and instructions for study participation or refusal to comply with protocol.
10. Current (within 7 days from start of Lotronex® use) use of fluvoxamine.
11. Chronic (≥ 6 months) use of narcotics or opioids.
12. The patient has used an investigational drug or participated in an investigational study within 30 days of Visit 1/ Screening Visit.
13. The patient is hypersensitive or has a known negative response to 5-HT3 antagonists.
14. Had a significant adverse event during previous treatment with Lotronex® or is currently using Lotronex®.

Primary outcomes:
measure: Change in stool consistency
timeFrame: At Week 4 and Week 12
measure: IBS pain severity
timeFrame: At Weeks 4 and 12
Secondary outcomes:
measure: Change from baseline in quality of life scores (IBSQOL).
timeFrame: Week 12
measure: Change from baseline stool frequency.
timeFrame: Week 4 and Week 12
measure: Change from baseline in fecal urgency.
timeFrame: Week 4 and Week 12
measure: Change from baseline in lost productivity.
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
facility: Gastroenterology Consultants Inc.
state: Alabama
city: Scottsdale
country: United States
facility: Digestive Health Research Unit
state: Arizona
city: Little Rock
country: United States
facility: Lynn Institute of the Ozarks
state: Arkansas
city: Beverly Hills
country: United States
facility: Adam D. Karns, MD
state: California
city: Irvine
country: United States
facility: Behavioral Research Specialists, LLC
state: California
city: Lomita
country: United States
facility: Torrance Clinical Research
state: California
city: Orange
country: United States
facility: Community Clinical Trials
state: California
city: Redlands
country: United States
facility: Inland Gastroenterology Medical Associates
state: California
city: San Carlos
country: United States
facility: Digestive Care Associates
state: California
city: San Diego
country: United States
facility: Clinical Applications Laboratories, Inc.
state: California
city: San Diego
country: United States
facility: Precision Research Institute, LLC
state: California
city: Colorado Springs
country: United States
facility: Delta Waves Sleep Disorders & Research Center
state: Colorado
city: LaFayette
country: United States
facility: Clinical Research of the Rockies
state: Colorado
city: Bridgeport
country: United States
facility: Gastroenterology Associates of Fairfield County
state: Connecticut
city: Boynton Beach
country: United States
facility: Consultants for Clinical Research of South Florida
state: Florida
city: Coral Gables
country: United States
facility: Sanitas Research
state: Florida
city: Deland
country: United States
facility: Avail Clinical Research, LLC
state: Florida
city: Hollywood
country: United States
facility: Southern Clinical Research Consultants
state: Florida
city: Jacksonville
country: United States
facility: Borland-Groover Clinic
state: Florida
city: Palm Harbor
country: United States
facility: Advanced Gastroenterology Associates, LLC
state: Florida
city: Pensacola
country: United States
facility: Gulf Regions Clinical Research Institute
state: Florida
city: Port Orange
country: United States
facility: Accord Clinical Research, LLC
state: Florida
city: Tampa
country: United States
facility: Bearss Medical
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Clinic, PA
state: Florida
city: Arlington Heights
country: United States
facility: Illinois Gastroenterology Group, LLC/Northwest Gastroenterologists
state: Illinois
city: Chicago
country: United States
facility: GI Solutions
state: Illinois
city: Elwood
country: United States
facility: Investigative Clinical Research of Indiana, LLC
state: Indiana
city: Davenport
country: United States
facility: Gastrointestinal Clinic of Quad Cities
state: Iowa
city: Shreveport
country: United States
facility: Louisiana Research Center, LLC
state: Louisiana
city: Chevy Chase
country: United States
facility: Metropolitan Gastroenterology Group, PC, Chevy Chase Clinical Research
state: Maryland
city: Hagerstown
country: United States
facility: Meritus Center for Clinical Research
state: Maryland
city: Brockton
country: United States
facility: Commonwealth Clinical Studies
state: Massachusetts
city: Troy
country: United States
facility: Troy Gastroenterology, PC
state: Michigan
city: Wyoming
country: United States
facility: Gastroenterology Associates of Western Michigan
state: Michigan
city: Mexico
country: United States
facility: Center for Digestive and Liver Diseases, Inc.
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Ocean
country: United States
facility: Howard Guss, DO
state: New Jersey
city: Brooklyn
country: United States
facility: Synergy First, LLC
state: New York
city: Great Neck
country: United States
facility: Long Island Clinical Research Associates
state: New York
city: Lake Success
country: United States
facility: New York Center for Clinical Research
state: New York
city: New York
country: United States
facility: Concorde Medical Group
state: New York
city: New York
country: United States
facility: NY Center for Women's Health Research
state: New York
city: Asheville
country: United States
facility: Asheville Gastroenterology Associates, PA
state: North Carolina
city: Greenville
country: United States
facility: Carolina Digestive Diseases
state: North Carolina
city: Harrisburg
country: United States
facility: Carolinas Research Associates
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Cincinnati
country: United States
facility: Consultants for Clinical Research of Cincinnati
state: Ohio
city: Cincinnati
country: United States
facility: Gastroenterology Research Consultants of Greater Cincinnati
state: Ohio
city: Mentor
country: United States
facility: Great Lakes Gastroenterology
state: Ohio
city: Tulsa
country: United States
facility: Gastroenterology United of Tulsa
state: Oklahoma
city: Portland
country: United States
facility: The Orgeon Clinic - West Hills Gastroenterology
state: Oregon
city: Bensalem
country: United States
facility: Pennsylvania Research Institute
state: Pennsylvania
city: Reading
country: United States
facility: Research Across America
state: Pennsylvania
city: Anderson
country: United States
facility: Anderson Gastroenterology Associates, LLC
state: South Carolina
city: Franklin
country: United States
facility: Franklin Gastroenterology, PLLC
state: Tennessee
city: Jackson
country: United States
facility: HCCA Clinical Research Solutions
state: Tennessee
city: Murfreesboro
country: United States
facility: Murfreesboro Medical Clinic
state: Tennessee
city: Arlington
country: United States
facility: Academy of Clinical Research
state: Texas
city: Arlington
country: United States
facility: ARAYVAN Clinical Research
state: Texas
city: Austin
country: United States
facility: Austin Center for Clinical Research
state: Texas
city: Carrollton
country: United States
facility: Trinity Clinical Research
state: Texas
city: Pasadena
country: United States
facility: Digestive Health Center
state: Texas
city: Spring
country: United States
facility: Spring Gastroenterology
state: Texas
city: West Valley
country: United States
facility: Granger Medical Clinic
state: Utah
city: Chesapeake
country: United States
facility: Gastroenterology Associates of Tidewater
state: Virginia
city: Norfolk
country: United States
facility: Digestive and Liver Disease Specialists
state: Virginia
city: Vancouver
country: United States
facility: Advanced Gastroenterology
state: Washington
Study officials:
affiliation: Prometheus Therapeutics and Diagnostics
name: Emil Chuang, MD
role: STUDY_DIRECTOR
References:
citation: Lacy BE, Nicandro JP, Chuang E, Earnest DL. Alosetron use in clinical practice: significant improvement in irritable bowel syndrome symptoms evaluated using the US Food and Drug Administration composite endpoint. Therap Adv Gastroenterol. 2018 May 8;11:1756284818771674. doi: 10.1177/1756284818771674. eCollection 2018.