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CLINICAL TRIALS PROFILE FOR LINZESS

All Clinical Trials for Linzess

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Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01950403	Linaclotide Acetate in Preventing Colorectal Cancer in Healthy Volunteers	Active, not recruiting	National Cancer Institute (NCI)	Phase 1	2013-09-01	This randomized phase I trial studies the side effects and best dose of linaclotide acetate in preventing colorectal cancer in healthy volunteers. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of linaclotide acetate may prevent colorectal cancer.
NCT01950403	Linaclotide Acetate in Preventing Colorectal Cancer in Healthy Volunteers	Active, not recruiting	Mayo Clinic	Phase 1	2013-09-01	This randomized phase I trial studies the side effects and best dose of linaclotide acetate in preventing colorectal cancer in healthy volunteers. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of linaclotide acetate may prevent colorectal cancer.
NCT02220348	A Lactation Study in Women Who Are Breastfeeding or Pumping and Are Receiving Linaclotide Therapeutically	Recruiting	Forest Laboratories	Phase 1	2014-07-01	The purpose of this study is to determine the amount of linaclotide and its active metabolite (MM-419447) excreted in breast milk after multiple, once daily doses of linaclotide (145 μg or 290 μg) in lactating women receiving the drug therapeutically.
NCT02270983	Phase 2 Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of Linaclotide Administered to Patients With Opioid-Induced Constipation Receiving Chronic Opioid Treatment for Non-Cancer Pain	Completed	Ironwood Pharmaceuticals, Inc.	Phase 2	2014-10-01	The purpose of this study is to evaluate the safety and efficacy of linaclotide for the treatment of opioid-induced constipation (OIC), in adults receiving stable opioid treatment for chronic non-cancer pain that has been present for a minimum of 3 months. This study includes up to a 4-week Screening Period, and a 2 to 3-week Pretreatment Period. Patients meeting the entry criteria will be randomized to 1 of 2 doses of linaclotide or placebo for 8 weeks. This 8-week study will assess the effects of linaclotide on bowel movement frequency, as well as other bowel symptoms of OIC.
NCT02270983	Phase 2 Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of Linaclotide Administered to Patients With Opioid-Induced Constipation Receiving Chronic Opioid Treatment for Non-Cancer Pain	Completed	Forest Laboratories	Phase 2	2014-10-01	The purpose of this study is to evaluate the safety and efficacy of linaclotide for the treatment of opioid-induced constipation (OIC), in adults receiving stable opioid treatment for chronic non-cancer pain that has been present for a minimum of 3 months. This study includes up to a 4-week Screening Period, and a 2 to 3-week Pretreatment Period. Patients meeting the entry criteria will be randomized to 1 of 2 doses of linaclotide or placebo for 8 weeks. This 8-week study will assess the effects of linaclotide on bowel movement frequency, as well as other bowel symptoms of OIC.
NCT02465385	Single-dose Linaclotide for Capsule Endoscopy Preparation	Completed	University of Virginia	Phase 4	2015-02-01	Video capsule endoscopy is an important procedure that can be used by doctors to find abnormalities in the small intestine, especially those that can cause bleeding. The procedure uses a tiny wireless camera to take pictures of the digestive tract. The camera sits inside a vitamin-sized capsule that a person can swallow. As the capsule travels through the digestive tract, the camera takes thousands of pictures that are transmitted to a recorder worn on a belt around a person's waist or over his/her shoulder. However, abnormalities can be missed partly because the normal dark liquids present in the intestine can prevent abnormalities from being recorded, hiding them from the physician who reviews the video. The current method used to clear these dark liquids from your small intestine is to follow a clear liquid diet and drink approximately 2 quarts of polyethylene glycol (Golytely®) the day before the video endoscopy and take simethicone (a medication used to treat symptoms of gas such as uncomfortable or painful pressure, fullness, and bloating) the morning of the test. Some of the current preparations to clear these dark liquids are not able to entirely prevent abnormalities from being missed and most have an unpleasant taste or involve drinking a lot of fluid. Linaclotide (Linzess®) is a medication approved by the Food and Drug Administration (FDA) for the treatment of constipation and irritable bowel syndrome. It is not approved by the FDA for use as an aid for clearing dark liquid from the small intestine prior to a video endoscopy. A recent presentation at a medical meeting proposed using one-dose of linaclotide (Linzess®) to improve cleansing of the small intestine for capsule endoscopy preparation to supplement fasting and clear liquid diet. This report claimed a noticeably better quality of small intestine cleansing and a 20% shorter transit time for the capsule by taking one dose of linaclotide one hour before patients swallowed the video capsule. The purpose of this study is to assess the use of one dose of linaclotide in terms of the total time it takes the capsule to move through the small bowel, and image quality as compared to the current method. The results of this study will be compared to previous patients who drank the preparation that is currently used
NCT02559206	Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)	Active, not recruiting	Forest Laboratories	Phase 2	2015-10-01	The objectives of this study are to evaluate the safety, efficacy, and dose response of two delayed release formulations of linaclotide (DR; DR formulation 1 is DR1; DR formulation 2 is DR2) administered orally to patients with irritable bowel syndrome with constipation (IBS-C). Additional objectives include understanding how the two DR formulations compare with each other and with the FDA-approved 290 μg LINZESS® (the immediate release [IR] formulation of linaclotide).
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