| Linzess (linaclotide) / Ironwood Pharma, AbbVie |
NCT01642914: Safety and Efficacy of Linaclotide in Patients With Chronic Constipation and Prominent Abdominal Bloating |
|
|
| Completed | 3b | 487 | US, Canada | Linaclotide 290 micrograms, Linaclotide 145 micrograms, Matching placebo | Forest Laboratories, Ironwood Pharmaceuticals, Inc. | Chronic Constipation, Constipation | 05/13 | 08/13 | | |
NCT03573908: A Trial of Linaclotide 290 μg in Patients With Irritable Bowel Syndrome With Constipation (IBS-C) |
|
|
| Completed | 3b | 614 | US | Linaclotide, Linzess, Placebo | Ironwood Pharmaceuticals, Inc., Allergan Sales, LLC | Irritable Bowel Syndrome Characterized by Constipation | 03/19 | 04/19 | | |
NCT00765882: Phase III, Randomized, Double-Blind, Placebo-Controlled, Trial of Linaclotide Administered to Patients With Chronic Constipation |
|
|
| Completed | 3 | 633 | US, Canada | Linaclotide 290 micrograms, Linaclotide 145 micrograms, Placebo | Forest Laboratories, Ironwood Pharmaceuticals, Inc. | Chronic Constipation | 07/09 | 08/09 | | |
NCT00730015: Trial of Linaclotide in Patients With Chronic Constipation |
|
|
| Completed | 3 | 643 | US | Matching Placebo, Linaclotide | Ironwood Pharmaceuticals, Inc., Forest Laboratories | Chronic Constipation | 08/09 | 10/09 | | |
NCT00948818: Trial of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation |
|
|
| Completed | 3 | 803 | US, Canada | Linaclotide 290 micrograms, Matching placebo | Forest Laboratories, Ironwood Pharmaceuticals, Inc. | Irritable Bowel Syndrome Characterized by Constipation | 07/10 | 08/10 | | |
NCT00938717: Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C) |
|
|
| Completed | 3 | 805 | US | Linaclotide or Matching Placebo | Ironwood Pharmaceuticals, Inc., Forest Laboratories | Irritable Bowel Syndrome With Constipation | 09/10 | 09/10 | | |
NCT00765999: An Open-Label, Long-Term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation |
|
|
| Completed | 3 | 1559 | Canada, US | Linaclotide, Linzess | Forest Laboratories, Ironwood Pharmaceuticals, Inc. | Chronic Constipation, Irritable Bowel Syndrome With Constipation | 01/12 | 01/12 | | |
NCT00730171: An Open-label, Long-term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation |
|
|
| Completed | 3 | 1743 | US | Linaclotide, Linzess | Ironwood Pharmaceuticals, Inc., Forest Laboratories | Irritable Bowel Syndrome With Constipation, Chronic Constipation | 03/12 | 03/12 | | |
NCT01880424: 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) |
|
|
| Completed | 3 | 1722 | US, Canada, RoW | Placebo, Linaclotide | AstraZeneca, Ironwood Pharmaceuticals, Inc. | Irritable Bowel Syndrome With Constipation (IBS-C) | 05/15 | 05/15 | | |
NCT02291679: Trial of Linaclotide in Patients With Chronic Idiopathic Constipation |
|
|
| Completed | 3 | 1223 | US | Linaclotide, Linzess, Constella, Matching Placebo | Ironwood Pharmaceuticals, Inc., Forest Laboratories | Chronic Idiopathic Constipation | 08/15 | 08/15 | | |
NCT02316899: Phase III Study to Evaluate the Efficacy and Safety of ASP0456 in Patients With Constipation Predominant Irritable Bowel Syndrome |
|
|
| Completed | 3 | 500 | Japan | linaclotide, ASP0456, Placebo | Astellas Pharma Inc | Irritable Bowel Syndrome With Constipation (IBS-C) | 09/15 | 03/16 | | |
2013-001248-67: Evaluation of predictors of response to linaclotide in patients with irritable bowel syndrome and explore the impact on intestinal symptoms Evaluacion de factores predictores de respuesta a linaclotida en pacientes con Síndrome de Intestino Irritable y explorar el impacto sobre los síntomas extraintestinales |
|
|
| Ongoing | 3 | 120 | Europe | Capsule, Constella | almirall, Almirall | Irritable bowel syndrome Síndrome de intestino irritable, Irritable bowel syndrome Sindrome de intestino irritable, Diseases [C] - Digestive System Diseases [C06] | | | | |
NCT02809105: A Study of Oral Dosing of ASP0456 in Patients With Chronic Constipation |
|
|
| Completed | 3 | 186 | Japan | linaclotide, ASP0456, Placebo | Astellas Pharma Inc | Chronic Constipation | 11/16 | 11/17 | | |
NCT04804267: Evaluation of Clinical Equivalence Between Two Linaclotide Products in the Treatment of Chronic Idiopathic Constipation |
|
|
| Recruiting | 3 | 750 | RoW | Linaclotide, LINZESS®, Placebo | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Chronic Idiopathic Constipation | 08/22 | 08/22 | | |
LINZESS, NCT04026113 / 2019-001500-38: Linaclotide Safety and Efficacy in Pediatric Participants, 6 to 17 Years of Age, With Irritable Bowel Syndrome With Constipation (IBS-C) or Functional Constipation (FC) |
|
|
| Completed | 3 | 438 | Europe, Canada, US, RoW | Linaclotide, Placebo | AbbVie, Ironwood Pharmaceuticals, Inc. | Functional Constipation, Irritable Bowel Syndrome With Constipation | 05/24 | 05/24 | | |
NCT05652205: A Study to Assess Adverse Events and Change in Symptoms With Linaclotide Versus Placebo in Pediatric Subjects, Ages 2 to 5 Years, With Functional Constipation |
|
|
| Completed | 3 | 123 | Europe, US | Linaclotide, Placebo for Linaclotide | AbbVie, Ironwood Pharmaceuticals, Inc. | Functional Constipation (FC), Chronic Idiopathic Constipation (CIC) | 09/25 | 09/25 | | |
| Completed | 3 | 381 | Europe, Canada, US, RoW | Irritable Bowel Syndrome with Constipation (IBS-C) participants (LIN-MD-63 and LIN-MD-64 completers), Functional Constipation (FC) participants (LIN-MD-62 and LIN-MD-64 completers) | AbbVie, Ironwood Pharmaceuticals, Inc. | Irritable Bowel Syndrome With Constipation, Functional Constipation | 06/25 | 06/25 | | |
NCT01352325: Efficacy of System Constellations in a General Population |
|
|
| Completed | 2/3 | 216 | Europe | system constellations seminar | Heidelberg University | Psychological Well-being | 12/11 | 12/11 | | |
