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CLINICAL TRIALS PROFILE FOR LINZESS
Clinical Trials for Linzess
| 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. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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