| Linzess (linaclotide) / Astellas, Ironwood Pharma, AbbVie |
NCT02559206: Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C) |
|
|
| Completed | 2b | 759 | US | Linaclotide, Matching Placebo | Ironwood Pharmaceuticals, Inc., Forest Laboratories | Irritable Bowel Syndrome With Constipation | 09/16 | 09/16 | | |
NCT00306748: Phase 2 Study of MD-1100 Acetate Administered for 14 Days to Patients Meeting Criteria for Chronic Constipation |
|
|
| Completed | 2 | 40 | US | MD-1100 Acetate | Ironwood Pharmaceuticals, Inc. | Constipation | | 08/06 | | |
NCT00258193: Phase 2 Study of MD-1100 Acetate on Gastrointestinal Transit in Patients With C-IBS |
|
|
| Completed | 2 | 36 | US | MD-1100 Acetate | Ironwood Pharmaceuticals, Inc. | Irritable Bowel Syndrome | | 09/06 | | |
NCT00402337: Dose-range-finding, Phase 2 Trial of Oral Linaclotide Acetate Administered to Patients With Chronic Constipation |
|
|
| Completed | 2 | 310 | US | linaclotide acetate, Matching placebo | Ironwood Pharmaceuticals, Inc. | Chronic Constipation | 12/07 | 02/08 | | |
NCT00460811: Randomized, Double-blind, Dose-range-finding, Phase 2 Study of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation (IBS-C) |
|
|
| Completed | 2 | 420 | US, Canada | Linaclotide Acetate, Matching placebo | Ironwood Pharmaceuticals, Inc. | Irritable Bowel Syndrome With Constipation | 02/08 | 04/08 | | |
NCT01714843: A Study to Evaluate the Effect of ASP0456 in Patients With Constipation Predominant Irritable Bowel Syndrome |
|
|
| Completed | 2 | 559 | Japan | linaclotide, ASP0456, placebo | Astellas Pharma Inc | Constipation-predominant Irritable Bowel Syndrome (IBS-C) | 12/13 | 12/13 | | |
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 | 2 | 254 | US | Linaclotide 145 micrograms, Linzess, Linaclotide 290 micrograms, Placebo | Forest Laboratories, Ironwood Pharmaceuticals, Inc. | Opioid-Induced Constipation | 08/15 | 10/15 | | |
NCT02425722: A Study to Evaluate Dose Responses of Efficacy and Safety of ASP0456 in Patient With Chronic Constipation |
|
|
| Completed | 2 | 383 | Japan | ASP0456, Linaclotide, Placebo | Astellas Pharma Inc | Chronic Constipation | 10/15 | 10/15 | | |
NCT02559570: A Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 6-17 Years Who Fulfill Modified Rome III Criteria for Child/Adolescent Functional Constipation (FC) |
|
|
| Completed | 2 | 173 | Canada, US | Placebo, LIN Dose A, LINZESS, LIN Dose B, LIN Dose C, LIN 145 µg | Forest Laboratories, Ironwood Pharmaceuticals, Inc. | Functional Constipation in Children Ages 6-17 Years | 04/18 | 05/18 | | |
LIN-MD-63, NCT02559817: A Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 7-17 Years, With Irritable Bowel Syndrome With Constipation |
|
|
| Terminated | 2 | 101 | Canada, US | Linaclotide Dose A, Linzess, Linaclotide Dose B, Linaclotide Dose C, Linaclotide Approved Adult Dose, Matching Placebo | Forest Laboratories, Ironwood Pharmaceuticals, Inc. | Irritable Bowel Syndrome With Constipation | 08/19 | 08/19 | | |
| Completed | 2 | 35 | US | Linaclotide, Placebo | Allergan, Ironwood Pharmaceuticals, Inc. | Functional Constipation | 04/21 | 04/21 | | |
NCT03796884: Linaclotide in Treating Patients With Stages 0-3 Colorectal Cancer |
|
|
| Active, not recruiting | 2 | 230 | US | Linaclotide, 851199-59-2, Linzess, [9-L-tyrosine]heat-stable enterotoxin (Escherichia coli)-(6-19)-peptide, L-Tyrosine, L-cysteinyl-L-cysteinyl-L-alpha-glutamyl-L-tyrosyl-L-cysteinyl-L-cysteinyl-L- asparaginyl-L-prolyl-L-alanyl-L-cysteinyl-L-threonylglycyl-L-cysteiny, cyclic (1->6), (2->10), (5->13)-tris(disulfide), MD-1100, Placebo | Sidney Kimmel Cancer Center at Thomas Jefferson University, United States Department of Defense | Colorectal Adenoma, Stage 0 Colorectal Cancer AJCC v8, Stage I Colorectal Cancer AJCC v8, Stage II Colorectal Cancer AJCC v8, Stage IIA Colorectal Cancer AJCC v8, Stage IIB Colorectal Cancer AJCC v8, Stage IIC Colorectal Cancer AJCC v8, Stage III Colorectal Cancer AJCC v8, Stage IIIA Colorectal Cancer AJCC v8, Stage IIIB Colorectal Cancer AJCC v8, Stage IIIC Colorectal Cancer AJCC v8 | 06/25 | 06/25 | | |
NCT05760313: A Study to Assess Adverse Events and Change in Disease Activity in Pediatric Participants (Age 6 Months to <2 Years) With Functional Constipation Who Are Treated With Linaclotide |
|
|
| Recruiting | 2 | 30 | Europe, US, RoW | Linaclotide, Linzess, Placebo | AbbVie, Ironwood Pharmaceuticals, Inc. | Functional Constipation | 09/25 | 09/25 | | |
