LOTRONEX® in Severe Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)

Irritable Bowel Syndrome Clinical Trial

— RELIANCE  

Official title:

Research Study to Evaluate LOTRONEX® in Severe IBS-D: Analysis of Current Clinical Practice Environment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01257477
• Other study ID #: 10LOT01
• Status: Completed
• Phase: N/A
• First received: December 7, 2010
• Last updated: April 1, 2013
• Start date: November 2010
• Est. completion date: March 2013

Study information

• Verified date: April 2013
• Source: Prometheus Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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®.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Irritable Bowel Syndrome

Locations

Country	Name	City	State
United States	Anderson Gastroenterology Associates, LLC	Anderson	South Carolina
United States	Academy of Clinical Research	Arlington	Texas
United States	ARAYVAN Clinical Research	Arlington	Texas
United States	Illinois Gastroenterology Group, LLC/Northwest Gastroenterologists	Arlington Heights	Illinois
United States	Asheville Gastroenterology Associates, PA	Asheville	North Carolina
United States	Austin Center for Clinical Research	Austin	Texas
United States	Pennsylvania Research Institute	Bensalem	Pennsylvania
United States	Adam D. Karns, MD	Beverly Hills	California
United States	Consultants for Clinical Research of South Florida	Boynton Beach	Florida
United States	Gastroenterology Associates of Fairfield County	Bridgeport	Connecticut
United States	Commonwealth Clinical Studies	Brockton	Massachusetts
United States	Synergy First, LLC	Brooklyn	New York
United States	Trinity Clinical Research	Carrollton	Texas
United States	Gastroenterology Associates of Tidewater	Chesapeake	Virginia
United States	Metropolitan Gastroenterology Group, PC, Chevy Chase Clinical Research	Chevy Chase	Maryland
United States	GI Solutions	Chicago	Illinois
United States	Consultants for Clinical Research of Cincinnati	Cincinnati	Ohio
United States	Gastroenterology Research Consultants of Greater Cincinnati	Cincinnati	Ohio
United States	Delta Waves Sleep Disorders & Research Center	Colorado Springs	Colorado
United States	Sanitas Research	Coral Gables	Florida
United States	Gastrointestinal Clinic of Quad Cities	Davenport	Iowa
United States	Avail Clinical Research, LLC	Deland	Florida
United States	Investigative Clinical Research of Indiana, LLC	Elwood	Indiana
United States	Franklin Gastroenterology, PLLC	Franklin	Tennessee
United States	Long Island Clinical Research Associates	Great Neck	New York
United States	Carolina Digestive Diseases	Greenville	North Carolina
United States	Meritus Center for Clinical Research	Hagerstown	Maryland
United States	Carolinas Research Associates	Harrisburg	North Carolina
United States	Southern Clinical Research Consultants	Hollywood	Florida
United States	Behavioral Research Specialists, LLC	Irvine	California
United States	HCCA Clinical Research Solutions	Jackson	Tennessee
United States	Borland-Groover Clinic	Jacksonville	Florida
United States	Clinical Research of the Rockies	LaFayette	Colorado
United States	New York Center for Clinical Research	Lake Success	New York
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Lynn Institute of the Ozarks	Little Rock	Arkansas
United States	Torrance Clinical Research	Lomita	California
United States	Great Lakes Gastroenterology	Mentor	Ohio
United States	Center for Digestive and Liver Diseases, Inc.	Mexico	Missouri
United States	Murfreesboro Medical Clinic	Murfreesboro	Tennessee
United States	Concorde Medical Group	New York	New York
United States	NY Center for Women's Health Research	New York	New York
United States	Digestive and Liver Disease Specialists	Norfolk	Virginia
United States	Howard Guss, DO	Ocean	New Jersey
United States	Community Clinical Trials	Orange	California
United States	Advanced Gastroenterology Associates, LLC	Palm Harbor	Florida
United States	Digestive Health Center	Pasadena	Texas
United States	Gulf Regions Clinical Research Institute	Pensacola	Florida
United States	Accord Clinical Research, LLC	Port Orange	Florida
United States	The Orgeon Clinic - West Hills Gastroenterology	Portland	Oregon
United States	Wake Research Associates	Raleigh	North Carolina
United States	Research Across America	Reading	Pennsylvania
United States	Inland Gastroenterology Medical Associates	Redlands	California
United States	Digestive Care Associates	San Carlos	California
United States	Clinical Applications Laboratories, Inc.	San Diego	California
United States	Precision Research Institute, LLC	San Diego	California
United States	Digestive Health Research Unit	Scottsdale	Arizona
United States	Louisiana Research Center, LLC	Shreveport	Louisiana
United States	Spring Gastroenterology	Spring	Texas
United States	Bearss Medical	Tampa	Florida
United States	Troy Gastroenterology, PC	Troy	Michigan
United States	Gastroenterology United of Tulsa	Tulsa	Oklahoma
United States	Gastroenterology Consultants Inc.	Tuscaloosa	Alabama
United States	Advanced Gastroenterology	Vancouver	Washington
United States	Granger Medical Clinic	West Valley	Utah
United States	Gastroenterology Associates of Western Michigan	Wyoming	Michigan
United States	Florida Medical Clinic, PA	Zephyrhills	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Prometheus Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in stool consistency	Stool consistency as measured by the Bristol Stool Form Scale. Change from baseline at Weeks 4 and 12 will be determined.	At Week 4 and Week 12	No
Primary	IBS pain severity	Pain intensity as measured by the 11-point numeric rating scale (NRS) will be averaged for each 4-week interval. Change from baseline at Weeks 4 and 12 will be determined.	At Weeks 4 and 12	No
Secondary	Change from baseline in quality of life scores (IBSQOL).	Change from baseline in IBSQOL scores will be calculated at Week 12.	Week 12	No
Secondary	Change from baseline stool frequency.	Stool frequency will be measured as the mean number of times per day that stools were passed, and will be averaged for each 4-week interval. Change from baseline at Weeks 4 and 12 will be determined	Week 4 and Week 12	No
Secondary	Change from baseline in fecal urgency.	Proportion of days with fecal urgency will be calculated for each 4-week interval and change from baseline will be determined at 4 and 12 weeks.	Week 4 and Week 12	No
Secondary	Change from baseline in lost productivity.	Lost workplace productivity and number of days IBS symptoms interfered with social/leisure and household activities will be determined at baseline and week 12. Change from baseline to week 12 will be calculated.	12 Weeks	No