Responders vs clinical response: a critical analysis of data from linaclotide phase 3 clinical trials in IBS-C
| Autor: | Anthony Lembo, Caroline B. Kurtz, M Currie, Jeffrey M. Johnston, James E. MacDougall, Brian E. Lacy, S J Shiff |
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| Jazyk: | angličtina |
| Rok vydání: | 2014 |
| Předmět: |
Adult
Male medicine.medical_specialty Abdominal pain Physiology clinical response Placebo Food and drug administration Irritable Bowel Syndrome chemistry.chemical_compound Young Adult Internal medicine medicine Humans Bowel function Young adult Linaclotide Irritable bowel syndrome complete spontaneous bowel movement Aged Aged 80 and over Endocrine and Autonomic Systems business.industry Gastroenterology abdominal pain Original Articles Middle Aged medicine.disease Surgery Clinical trial guanylate cyclase type-C receptor Treatment Outcome chemistry Clinical Trials Phase III as Topic IBS-C Female medicine.symptom business Peptides |
| Zdroj: | Neurogastroenterology and Motility |
| ISSN: | 1365-2982 1350-1925 |
| Popis: | Background US Food and Drug Administration (FDA) set a rigorous standard for defining patient responders in irritable bowel syndrome-C (IBS-C; i.e., FDA's Responder Endpoint) for regulatory approval. However, this endpoint's utility for health-care practitioners to assess clinical response has not been determined. We analyzed pooled IBS-C linaclotide trial data to evaluate clinically significant responses in linaclotide-treated patients who did not meet the FDA responder definition. Methods Percentages of FDA non-responders reporting improvement in abdominal pain, bowel function and/or global relief measures were determined using pooled data from two linaclotide Phase 3 IBS-C trials. Key Results 1602 IBS-C patients enrolled; 34% of linaclotide-treated and 17% of placebo-treated patients met the FDA Responder Endpoint (p |
| Databáze: | OpenAIRE |
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