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

Completed

Conditions studied: Irritable Bowel Syndrome

In brief

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

Key facts

Study ID

NCT01257477

Run by

Prometheus Laboratories

People needed

400

Starts

2010-11-01

Expected to finish

2013-03-01

Last updated by the study team

2013-04-04

Who can join

Age: 18 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Be a female between 18 and 65 years of age (inclusive) at Visit 1.
• Sign and date a written informed consent form prior to the initiation of any study-related activities, including discontinuation of any prohibited medications.
• Be diagnosed with severe, diarrhea-predominant IBS.
• Have experienced chronic IBS symptoms lasting 6 months or longer.
• Have not responded adequately to other IBS therapy.
• 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.

You may not qualify if…

• Has had a period of 3 consecutive days without a bowel movement in the past 14 days.
• 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.
• Has recurrent bowel obstruction of the small intestine or colon.
• Has had bloody diarrhea or abdominal pain with rectal bleeding in the past 14 days (except rectal bleeding due to hemorrhoids).
• Has a known biochemical or anatomical abnormality of the gastrointestinal tract.
• Has a history of thrombophlebitis or hypercoagulable state.
• Has a history of atherosclerosis.
• 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.)
• Mental impairment of inability to understand the medication guide and instructions for study participation or refusal to comply with protocol.
• Current (within 7 days from start of Lotronex® use) use of fluvoxamine.
• Chronic (≥ 6 months) use of narcotics or opioids.
• The patient has used an investigational drug or participated in an investigational study within 30 days of Visit 1/ Screening Visit.
• The patient is hypersensitive or has a known negative response to 5-HT3 antagonists.
• Had a significant adverse event during previous treatment with Lotronex® or is currently using Lotronex®.

Where it is running

• Digestive Health Research Unit — Scottsdale, Arizona, United States
• Lynn Institute of the Ozarks — Little Rock, Arkansas, United States
• Adam D. Karns, MD — Beverly Hills, California, United States
• Behavioral Research Specialists, LLC — Irvine, California, United States
• Torrance Clinical Research — Lomita, California, United States
• Community Clinical Trials — Orange, California, 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
• Delta Waves Sleep Disorders & Research Center — Colorado Springs, Colorado, United States
• Clinical Research of the Rockies — Lafayette, Colorado, United States
• Gastroenterology Associates of Fairfield County — Bridgeport, Connecticut, United States
• Consultants for Clinical Research of South Florida — Boynton Beach, Florida, United States
• Sanitas Research — Coral Gables, Florida, United States
• Avail Clinical Research, LLC — DeLand, Florida, United States
• Southern Clinical Research Consultants — Hollywood, Florida, United States
• Borland-Groover Clinic — Jacksonville, Florida, United States
• Advanced Gastroenterology Associates, LLC — Palm Harbor, Florida, United States
• Gulf Regions Clinical Research Institute — Pensacola, Florida, United States
• Accord Clinical Research, LLC — Port Orange, Florida, United States
• Bearss Medical — Tampa, Florida, United States
• Florida Medical Clinic, PA — Zephyrhills, Florida, United States
• Illinois Gastroenterology Group, LLC/Northwest Gastroenterologists — Arlington Heights, Illinois, United States
• Gastroenterology Consultants Inc. — Tuscaloosa, Alabama, United States

Full record on ClinicalTrials.gov

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