Short Bowel Syndrome
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CLINICAL_TRIALS trial_result · 2016-02-22Clinical Trial Update: Short Bowel Syndrome and Teduglutide Versus Placebo [Phase 4]
Phase 4 clinical trial comparing teduglutide to placebo in short bowel syndrome has completed and posted results in 2016.
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FDA approval · 2015-10-05FDA Approved: GATTEX — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
FDA approved a supplemental application for GATTEX (teduglutide) submitted by Takeda Pharmaceuticals America, Inc.
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CLINICAL_TRIALS trial_result · 2015-09-14Clinical Trial Update: A Pharmacokinetic, Safety, and Pharmacodynamic Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome [Phase 3]
Phase 3 pediatric pharmacokinetic, safety, and pharmacodynamic study of teduglutide in short bowel syndrome has completed with results poste…
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FDA approval · 2015-05-18FDA Approved: GATTEX — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for GATTEX (teduglutide) filed by Takeda Pharmaceuticals America, Inc.
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CLINICAL_TRIALS withdrawal · 2015-02-18Clinical Trial Update: A Open Label Extension Study for Subjects That Complete Study MP-101-CL-001 [Phase 3]
The Phase 3 open-label extension MP-101-CL-001 for short bowel syndrome has been withdrawn.
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CLINICAL_TRIALS withdrawal · 2015-02-18Clinical Trial Update: A Phase III Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Investigational Product MP-101 in Subjects With Short Bowel Syndrome Who Have Had an Inadequate Response to Anti-Diarrheals [Phase 3]
Phase III trial of MP-101 for short bowel syndrome has been withdrawn due to inadequate response to anti-diarrheals.
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FDA approval · 2015-01-05FDA Approved: GATTEX — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for Gattex (teduglutide) submitted by Takeda Pharmaceuticals America, Inc. The action updates th…
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CLINICAL_TRIALS trial_result · 2014-12-25Clinical Trial Update: A One-Year, Open-Label Study With Teduglutide for Subjects Who Completed Study CL0600-021 [Phase 3]
Open-label extension study of teduglutide in subjects who completed a prior study for short bowel syndrome; completed Phase 3 trial with res…
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CLINICAL_TRIALS trial_result · 2014-12-24Clinical Trial Update: Open-Label Study of Teduglutide for Subjects With PN-Dependent Short Bowel Syndrome (SBS) [Phase 3]
Open-label Phase 3 trial evaluating teduglutide in subjects with parenteral nutrition-dependent short bowel syndrome has completed with resu…
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CLINICAL_TRIALS trial_result · 2014-12-23Clinical Trial Update: Safety and Dosing Study of Glucagon-like Peptide 2 (GLP-2) in Infants and Children With Intestinal Failure [Phase 1, Phase 2]
A terminated Phase 1/2 safety and dosing study evaluated glucagon-like peptide 2 in infants and children with intestinal failure, including …
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CLINICAL_TRIALS trial_result · 2014-12-03Clinical Trial Update: Energy Metabolism in Patients With Short Bowel Syndrome
A completed clinical trial from the University of Sao Paulo studying energy metabolism in patients with Short Bowel Syndrome.
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CLINICAL_TRIALS trial_result · 2014-07-17Clinical Trial Update: Limited Long Term Survival in Patients After In-hospital Intestinal Failure Requiring Total Parenteral Nutrition
A completed clinical trial reports limited long-term survival in patients with intestinal failure who required total parenteral nutrition du…
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FDA approval · 2014-06-26FDA Approved: GATTEX — Supplemental Application (Takeda Pharmaceuticals America, Inc.)
The FDA approved a supplemental application for GATTEX (teduglutide) submitted by Takeda Pharmaceuticals America, Inc.
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CLINICAL_TRIALS trial_result · 2014-06-13Clinical Trial Update: Safety and Immunogenicity of Rotavirus Vaccine (RotaTeq(R)) in Infants With Short Bowel Syndrome [Phase 1]
Phase 1 clinical trial update reporting safety and immunogenicity of the Rotavirus vaccine RotaTeq in infants with short bowel syndrome, wit…
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CLINICAL_TRIALS trial_result · 2014-03-31Clinical Trial Update: rHGH and Intestinal Permeability in Intestinal Failure [Phase 4]
Phase 4 trial evaluating recombinant human growth hormone for intestinal permeability in short bowel syndrome; results were posted in 2014.
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CLINICAL_TRIALS withdrawal · 2014-01-15Clinical Trial Update: Fiber Use in Pediatric Short Bowel Syndrome [NA]
Clinical trial investigating fiber use in pediatric Short Bowel Syndrome has been withdrawn (NCT00922805).
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CLINICAL_TRIALS withdrawal · 2014-01-14Clinical Trial Update: Exenatide on GI Motor Function and Permeability in Short Bowel Syndrome [Phase 4]
A Phase 4 clinical trial evaluating Exenatide for gastrointestinal motor function and permeability in Short Bowel Syndrome has been withdraw…
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CLINICAL_TRIALS research · 2013-12-17Clinical Trial Update: Mechanisms of Adaptation in Human Short Bowel Syndrome
This clinical trial update summarizes research on mechanisms of adaptation in humans with Short Bowel Syndrome and notes the trial status as…
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CLINICAL_TRIALS trial_result · 2013-07-15Clinical Trial Update: Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome [Phase 3]
Phase 3 safety and efficacy study of teduglutide in subjects with Short Bowel Syndrome completed.
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CLINICAL_TRIALS trial_result · 2013-04-23Clinical Trial Update: Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome Who Completed Protocol CL0600-004 (NCT00081458) [Phase 3]
Phase 3 trial update on teduglutide for short bowel syndrome, reporting safety and efficacy in subjects who completed the protocol.
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FDA approval · 2012-12-21FDA Approved: GATTEX — Original Application (Takeda Pharmaceuticals America, Inc.)
FDA approved GATTEX (teduglutide) from Takeda Pharmaceuticals America as an Original Application for the treatment of short bowel syndrome t…
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CLINICAL_TRIALS trial_result · 2012-12-03Clinical Trial Update: Efficacy and Safety of Omega-3 Lipid Therapy in Pediatric Patients With Parenteral Nutrition-Associated Liver Disease [Phase 2]
A Phase 2 clinical trial update evaluating the efficacy and safety of omega-3 lipid therapy in pediatric patients with parenteral nutrition–…
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CLINICAL_TRIALS trial_result · 2012-10-01Clinical Trial Update: Prescription Pattern of Adjuvant Drugs and Vitamins in Patients Undergoing Long-term Home Nutritional Support for Intestinal Insufficiency
This completed clinical trial update reports on the prescription patterns of adjuvant drugs and vitamins used in long-term home nutritional …
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EMA approval · 2012-06-22European Medicines Agency recommends first medical treatment for patients with short bowel syndrome
EMA recommends the first medical treatment option for patients with short bowel syndrome, signaling a potential new therapy option in this c…
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CLINICAL_TRIALS trial_result · 2012-02-01Clinical Trial Update: Study of Teduglutide Effectiveness in Parenteral Nutrition (PN)-Dependent Short Bowel Syndrome (SBS) Subjects [Phase 3]
Phase 3 trial evaluating teduglutide for effectiveness in adults with parenteral nutrition-dependent short bowel syndrome has completed with…