A Trial of Linaclotide 290 μg in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

Completed · Phase 3 · Has a placebo group

Conditions studied: Irritable Bowel Syndrome Characterized by Constipation

In brief

To evaluate the efficacy on abdominal symptoms (abdominal bloating, abdominal discomfort, and abdominal pain) and safety of linaclotide 290 μg administered orally to patients with IBS-C.

Key facts

Study ID

NCT03573908

Run by

Ironwood Pharmaceuticals, Inc.

People needed

614

Starts

2018-06-20

Expected to finish

2019-04-10

Last updated by the study team

2020-12-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient has no clinically significant findings on a physical examination and clinical laboratory tests
• Female patients of childbearing potential must agree to use one of the following methods of birth control:
• Hormonal contraception
• Double-barrier birth control
• Maintenance of a monogamous relationship with a male partner who has been surgically sterilized by vasectomy
• Patient meets protocol criteria for diagnosis of IBS-C
• Patient demonstrates continued IBS-C symptoms through Pretreatment Period
• Patient maintains a minimum level of compliance with daily diary

You may not qualify if…

• Patient has history of loose or watery stools
• Patient has symptoms of or been diagnosed with a medical condition that may contribute to abdominal pain
• Patient has a structural abnormality of the gastrointestinal (GI) tract or a disease or condition that can affect GI motility
• Patient has any protocol-excluded or clinically significant medical or surgical history that could confound the study assessments

Where it is running

• Elite Clinical Studies — Phoenix, Arizona, United States
• Adobe Clinical Research, LLC — Tucson, Arizona, United States
• Arkansas Gastroenterology — North Little Rock, Arkansas, United States
• GW Research, Inc. — Chula Vista, California, United States
• Kindred Medical Institute for Clinical Trials, LLC — Corona, California, United States
• Diagnamics, Inc. — Encinitas, California, United States
• MD Studies, Inc. — Fountain Valley, California, United States
• Paragon Rx Clinical, Inc. - Garden Grove — Garden Grove, California, United States
• Grossmont Center For Clinical Research — La Mesa, California, United States
• Facey Medical Foundation — Mission Hills, California, United States
• Providence Clinical Research — North Hollywood, California, United States
• Precision Research Institute — San Diego, California, United States
• Paragon Rx Clinical, Inc.- Santa Ana — Santa Ana, California, United States
• Millennium Clinical Trials — Thousand Oaks, California, United States
• St. Joseph Heritage Healthcare — Yorba Linda, California, United States
• Connecticut Clinical Research Institute — Bristol, Connecticut, United States
• Chase Medical Research, LLC — Waterbury, Connecticut, United States
• Clinical Research of South Florida — Coral Gables, Florida, United States
• Avail Clinical Research, LLC — DeLand, Florida, United States
• Palmetto Research, LLC — Hialeah, Florida, United States
• Nature Coast Clinical Research, LLC — Inverness, Florida, United States
• The Chappel Group Research — Kissimmee, Florida, United States
• Jesscan Medical Research — Miami, Florida, United States
• Well Pharma Medical Research Corporation — Miami, Florida, United States
• Clinical Research Associates — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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