Idiopathic Constipation
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CLINICAL_TRIALS trial_result · 2019-07-02Clinical Trial Update: Open-label Extension (OLE) Study of Plecanatide for Chronic Idiopathic Constipation (CIC) [Phase 3]
Open-label extension study update for plecanatide in chronic idiopathic constipation completed; results posted in 2019.
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CLINICAL_TRIALS trial_result · 2019-07-02Clinical Trial Update: Efficacy of Linaclotide to Senna for CIC [NA]
Clinical trial update on the efficacy comparison between linaclotide and senna for chronic idiopathic constipation; study terminated with po…
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CLINICAL_TRIALS trial_result · 2019-04-01Clinical Trial Update: Lubiprostone for Chronic Idiopathic Constipation Treatment [Phase 3]
Phase 3 trial for lubiprostone in chronic idiopathic constipation completed with posted results.
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CLINICAL_TRIALS trial_result · 2019-03-21Clinical Trial Update: 12-Week Study of Plecanatide for CIC (The CIC3 Study) [Phase 3]
Phase 3 trial update for plecanatide in chronic idiopathic constipation (CIC) completed with results posted in 2019.
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CLINICAL_TRIALS trial_result · 2019-03-14Clinical Trial Update: 12-Week Study of Plecanatide for CIC (The National CIC3 Study) [Phase 3]
Phase 3 trial update for plecanatide in chronic idiopathic constipation completed with results posted in 2019.
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CLINICAL_TRIALS trial_result · 2018-12-31Clinical Trial Update: Lubiprostone for Treatment of Chronic Idiopathic Constipation [Phase 3]
A Phase 3 clinical trial update for lubiprostone in chronic idiopathic constipation has completed and posted results.
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FDA approval · 2018-12-14FDA Approved: MOTEGRITY — Original Application (Takeda Pharmaceuticals America, Inc.)
FDA approved MOTEGRITY for chronic idiopathic constipation in adults in an original NDA from Takeda Pharmaceuticals America, Inc. (prucalopr…
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FDA approval · 2018-07-25FDA Approved: TRULANCE IMMEDIATE RELEASE — Supplemental Application (Salix Pharmaceuticals Inc.)
The FDA approved a Supplemental Application for TRULANCE IMMEDIATE RELEASE (plecanatide) from Salix Pharmaceuticals Inc. This action concern…
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CLINICAL_TRIALS trial_result · 2018-07-13Clinical Trial Update: Effects of Lubiprostone on Gastric Function in Patients With Chronic Idiopathic Constipation [Phase 4]
A Phase 4 clinical trial assessing the effect of lubiprostone on gastric function in adults with chronic idiopathic constipation; results po…
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FDA approval · 2018-04-26FDA Approved: LUBIPROSTONE — Supplemental Application (Dr. Reddy's Laboratories Inc.)
FDA approved a supplemental application for Lubiprostone filed by Dr. Reddy's Laboratories Inc.
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CLINICAL_TRIALS trial_result · 2018-01-30Clinical Trial Update: Botulinum Toxin Injection Versus Anal Myectomy in Management of Idiopathic Constipation [Phase 4]
Phase 4 trial update comparing botulinum toxin injection to anal myectomy for chronic/functional constipation; current status is unknown.
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FDA approval · 2018-01-24FDA Approved: TRULANCE IMMEDIATE RELEASE — Supplemental Application (Salix Pharmaceuticals Inc.)
FDA approved a supplemental application for an immediate-release formulation of Trulance (plecanatide) from Salix Pharmaceuticals, expanding…
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CLINICAL_TRIALS trial_result · 2017-11-29Clinical Trial Update: The Plecanatide Chronic Idiopathic Constipation (CIC) Study [Phase 2, Phase 3]
Clinical trial update for plecanatide in chronic idiopathic constipation completed phases 2 and 3 with results posted.
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CLINICAL_TRIALS trial_result · 2017-11-07Clinical Trial Update: Performance, Efficacy and Safety of Vibrating Capsule in Aiding Constipated Individuals [NA]
The clinical trial evaluating the Vibrating Capsule for chronic idiopathic constipation has completed. The update summarizes the performance…
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FDA label_change · 2017-08-01FDA Approved: LUBIPROSTONE — Supplemental Application (Dr. Reddy's Laboratories Inc.)
FDA approved a supplemental application for Lubiprostone filed by Dr. Reddy's Laboratories to update the product labeling with expanded indi…
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CLINICAL_TRIALS trial_result · 2017-05-19Clinical Trial Update: Trial of Linaclotide in Patients With Chronic Idiopathic Constipation [Phase 3]
The Phase 3 trial of linaclotide in chronic idiopathic constipation has been completed, and results were posted in May 2017.
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CLINICAL_TRIALS trial_result · 2017-03-22Clinical Trial Update: Study of Elobixibat (A3309) in Patients With Chronic Idiopathic Constipation [Phase 2]
Elobixibat (A3309) was studied in a Phase 2 trial for chronic idiopathic constipation; the study completed and results were posted in 2017.
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FDA approval · 2017-01-19FDA Approved: TRULANCE IMMEDIATE RELEASE — Original Application (Salix Pharmaceuticals Inc.)
The FDA approved Trulance immediate-release (plecanatide) from Salix Pharmaceuticals in an original NDA for the treatment of chronic idiopat…
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FDA approval · 2017-01-06FDA Approved: LINZESS — Supplemental Application (Allergan, Inc.)
FDA approved a supplemental application for Linzess (linaclotide) filed by Allergan, expanding its regulatory status.
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FDA approval · 2016-10-11FDA Approved: LUBIPROSTONE — Supplemental Application (Dr. Reddy's Laboratories Inc.)
FDA approved a supplemental application for Lubiprostone from Dr. Reddy's Laboratories Inc., typically reflecting updates to labeling or ind…
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CLINICAL_TRIALS trial_result · 2016-08-01Clinical Trial Update: Lubiprostone Effect on Gastrointestinal Tract Transit Times Measured by Smartpill in Patients With Chronic Constipation [Phase 2, Phase 3]
This update reports results from Phase 2/3 trials evaluating lubiprostone's effect on gastrointestinal transit times in adults with chronic …
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FDA approval · 2016-05-18FDA Approved: LINZESS — Supplemental Application (Allergan, Inc.)
FDA has approved a supplemental application for Linzess (linaclotide) from Allergan, expanding the labeling for the product.
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CLINICAL_TRIALS trial_result · 2016-05-09Clinical Trial Update: Safety and Tolerability Extension Trial for Patients With Chronic Idiopathic Constipation [Phase 3]
Safety and tolerability data from a Phase 3 extension trial in patients with Chronic Idiopathic Constipation, sponsored by Ferring Pharmaceu…
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FDA approval · 2016-04-06FDA Approved: LINZESS — Supplemental Application (Allergan, Inc.)
FDA approved Allergan's supplemental application for LINZESS (linaclotide).
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FDA approval · 2015-11-23FDA Approved: LINZESS — Supplemental Application (Allergan, Inc.)
The FDA approved a supplemental application for LINZESS (linaclotide) submitted by Allergan, Inc. This action updates the regulatory status …