Irritable Bowel Syndrome with Constipation
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CLINICAL_TRIALS trial_result · 2019-08-20Clinical Trial Update: The Effect of CSP01 on Chronic Idiopathic Constipation and Irritable Bowel Syndrome With Constipation [NA]
Clinical trial update on CSP01 for chronic idiopathic constipation and irritable bowel syndrome with constipation has completed with results…
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CLINICAL_TRIALS trial_result · 2019-06-14Clinical Trial Update: The Plecanatide Irritable Bowel Syndrome With Constipation Study (IBS-C) [Phase 3]
Phase 3 trial update for plecanatide in irritable bowel syndrome with constipation (IBS-C) completed with results posted.
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CLINICAL_TRIALS trial_result · 2019-06-14Clinical Trial Update: Second Plecanatide Study In Irritable Bowel Syndrome With Constipation (IBS-C) [Phase 3]
Phase 3 trial update for plecanatide in irritable bowel syndrome with constipation has completed, with results posted in 2019.
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CLINICAL_TRIALS trial_result · 2019-02-15Clinical Trial Update: An Open-Label, Long-Term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation [Phase 3]
An open-label, long-term safety study evaluating linaclotide in patients with chronic constipation or irritable bowel syndrome with constipa…
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CLINICAL_TRIALS trial_result · 2018-09-17Clinical Trial Update: The Plecanatide Irritable Bowel Syndrome With Constipation Study (IBS-C) [Phase 2]
Phase 2 clinical trial update for plecanatide in irritable bowel syndrome with constipation (IBS-C) completed with results posted in 2018.
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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 · 2018-07-23Clinical Trial Update: Investigation of Linaclotide's Effect on the Bi-directional Brain and Gut Axis in IBS-C Patients [NA]
A completed clinical trial evaluating the effects of linaclotide on the brain-gut axis in patients with irritable bowel syndrome with consti…
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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 · 2018-02-19Clinical Trial Update: An Open-label, Long-term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation [Phase 3]
Open-label, long-term safety study of linaclotide in chronic constipation and irritable bowel syndrome with constipation completed with resu…
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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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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 · 2017-03-08Clinical Trial Update: A Study of the Effect of SYN-010 on Subjects With IBS-C [Phase 2]
Phase 2 clinical trial update for SYN-010 in Irritable Bowel Syndrome With Constipation (IBS-C) has completed with results posted in 2017.
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CLINICAL_TRIALS trial_result · 2017-03-08Clinical Trial Update: A Single-Dose, Open-Label, Study to Evaluate the Sustainability of the Effects of SYN-010 in Patients With IBS-C [Phase 2]
Phase 2 trial assessing sustainability of effects of SYN-010 in Irritable Bowel Syndrome with Constipation (IBS-C); study completed with res…
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CLINICAL_TRIALS trial_result · 2017-01-20Clinical Trial Update: A Single-centre, Randomised, Double-blind, Controlled, Parallel-group Study to Evaluate the Effect of a Fermented Dairy Product on Abdominal Distension, Digestive Symptoms and Rectal Sensitivity in Patients With Irritable Bowel Syndrome With Constipation (IBS-C) [NA]
A single-centre randomized, double-blind, parallel-group trial evaluated a fermented dairy product for effects on abdominal distension, dige…
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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 · 2016-09-27Clinical Trial Update: A Phase 3, International, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Trial of Linaclotide Administered Orally for 12 Weeks to Patients With Irritable Bowel Syndrome With Constipation (IBS-C) [Phase 3]
This update notes the completion of a Phase 3, randomized, double-blind trial evaluating oral linaclotide for irritable bowel syndrome with …
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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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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 …
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CLINICAL_TRIALS trial_result · 2015-05-05Clinical Trial Update: Effect of Mosapride on Gut Transit in Patients With Chronic Constipation or Constipated Irritable Bowel Syndrome and Healthy Subjects [Phase 4]
This Phase 4 clinical trial update describes a study evaluating the effect of mosapride on gut transit in patients with chronic constipation…
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FDA approval · 2015-01-05FDA Approved: LINZESS — Supplemental Application (Allergan, Inc.)
The FDA approved a supplemental application for Linzess (linaclotide) from Allergan, Inc., indicating agency approval of a supplemental NDA …
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FDA approval · 2014-12-11FDA Approved: LINZESS — Supplemental Application (Allergan, Inc.)
The FDA approved a supplemental application for Linzess (linaclotide) from Allergan, expanding its labeling.
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FDA approval · 2014-07-09FDA Approved: LINZESS — Supplemental Application (Allergan, Inc.)
FDA approved a supplemental application for Linzess (linaclotide) filed by Allergan, Inc.