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CLINICAL TRIALS PROFILE FOR LINZESS

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Clinical Trials for Linzess

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT01950403	Linaclotide Acetate in Preventing Colorectal Cancer in Healthy Volunteers	Active, not recruiting	National Cancer Institute (NCI)	Phase 1	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	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	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	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.

Clinical Trial Conditions for Linzess

Condition Name

Condition Name for Linzess
Intervention	Trials
Irritable Bowel Syndrome With Constipation	3
Colorectal Cancer	1
Healthy, no Evidence of Disease	1
Chronic Idiopathic Constipation	1

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Condition MeSH

Condition MeSH for Linzess
Intervention	Trials
Constipation	8
Irritable Bowel Syndrome	5
Syndrome	4
Colorectal Neoplasms	1

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Clinical Trial Locations for Linzess

Trials by Country

Trials by Country for Linzess
Location	Trials
United States	168
Canada	6

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Trials by US State

Trials by US State for Linzess
Location	Trials
Pennsylvania	7
Virginia	7
Texas	7
Massachusetts	6
Florida	6

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Clinical Trial Progress for Linzess

Clinical Trial Phase

Clinical Trial Phase for Linzess
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	1
Phase 2	4

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Clinical Trial Status

Clinical Trial Status for Linzess
Clinical Trial Phase	Trials
Recruiting	4
Active, not recruiting	4
Completed	2

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Clinical Trial Sponsors for Linzess

Sponsor Name

Sponsor Name for Linzess
Sponsor	Trials
Ironwood Pharmaceuticals, Inc.	6
Forest Laboratories	4
Forest Laboratories, LLC, an Allergan Affiliate	2

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Sponsor Type

Sponsor Type for Linzess
Sponsor	Trials
Industry	13
Other	3
NIH	1

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