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Linzess (Linaclotide) - Summary



LINZESS is contraindicated in pediatric patients up to 6 years of age; in nonclinical studies, administration of a single, clinically relevant adult oral dose of linaclotide caused deaths due to dehydration in young juvenile mice. Avoid use of LINZESS in pediatric patients 6 through 17 years of age. The safety and efficacy of LINZESS has not been established in pediatric patients under 18 years of age [see Contraindications (4), Warnings and Precautions Use in Specific Populations and Nonclinical Toxicology].



LINZESS (linaclotide) is a guanylate cyclase-C agonist. Linaclotide is a 14-amino acid peptide.

LINZESS (linaclotide) is indicated for the following:

Irritable Bowel Syndrome with Constipation (IBS-C)

LINZESS (linaclotide) is indicated in adults for the treatment of irritable bowel syndrome with constipation (IBS-C).

Chronic Idiopathic Constipation (CIC)

LINZESS is indicated in adults for the treatment of chronic idiopathic constipation (CIC).

See all Linzess indications & dosage >>


Published Studies Related to Linzess (Linaclotide)

Impact of linaclotide treatment on work productivity and activity impairment in adults with irritable bowel syndrome with constipation: results from 2 randomized, double-blind, placebo-controlled phase 3 trials. [2014]
indirect costs associated with this condition... CONCLUSION: The results of this analysis indicate that appropriate treatment of

Linaclotide: a novel approach to the treatment of irritable bowel syndrome. [2011]
CONCLUSIONS: Linaclotide appears to be a safe and effective treatment for IBS.

Efficacy of linaclotide for patients with chronic constipation. [2010]
a range of linaclotide doses in patients with chronic constipation... CONCLUSIONS: Linaclotide therapy was associated with few adverse events and

Pilot study on the effect of linaclotide in patients with chronic constipation. [2009]
frequency, and loosened stool consistency... CONCLUSIONS: In this pilot study, linaclotide treatment improved bowel habits and

Effect of 5 days linaclotide on transit and bowel function in females with constipation-predominant irritable bowel syndrome. [2007]
transit was normal in >50% patients... CONCLUSIONS: In women with constipation-predominant irritable bowel syndrome,

more studies >>

Clinical Trials Related to Linzess (Linaclotide)

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 [Active, not recruiting]
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.

Linaclotide Acetate in Preventing Colorectal Cancer in Healthy Volunteers [Active, not recruiting]

Efficacy of Linaclotide to Senna for CIC [Recruiting]
In this prospective, randomized, double blind study, the aim is to determine the efficacy of Linaclotide in relation to Senna in relieving the symptoms of chronic idiopathic

constipation (CIC). Patients with CIC, (age 18 - 70) will be enrolled in the study and

randomized to Senna or Linaclotide. Patients will be asked to complete questionnaires during the study and will be followed for 12 weeks. Main outcomes include number of daily bowel movements and measures from surveys regarding bowel habits, relief, and satisfaction.

Single-dose Linaclotide for Capsule Endoscopy Preparation [Recruiting]
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

Safety and Efficacy of Linaclotide in Patients With Chronic Constipation and Prominent Abdominal Bloating [Completed]
The purpose of this study is to evaluate the efficacy and safety of linaclotide compared with placebo in patients with chronic constipation (CC) and prominent abdominal bloating. This study includes an up to 3-week screening period and a 2-3 week pretreatment period. Patients who are eligible will be randomized to one of two doses of linaclotide or placebo for 12 weeks. This 12-week study will assess the effects of linaclotide on bowel movement frequency, as well as other abdominal and bowel symptoms of CC.

more trials >>

Page last updated: 2014-11-30

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