An evaluation of the FDA Responder Endpoint for IBS-C clinical trials: Analysis of data from linaclotide Phase 3 clinical trials

Neurogastroenterology and Motility

Volumn 25, Issue 6, 2013, Pages 481-e365

  Macdougall, J E ^a   Johnston, J M ^a   Lavins, B J ^a   Nelson, L M ^b   Williams, V S L ^b   Carson, R T ^c   Shiff, S J ^c   Shi, K ^c   Kurtz, C B ^a   Baird, M J ^a   Currie, M G ^a   Lembo, A J ^d  

^a Ironwood Pharmaceuticals   (United States)

^b RTI INTERNATIONAL   (United States)

^c FOREST RESEARCH INSTITUTE   (United States)

^d HARVARD MEDICAL SCHOOL   (United States)

Author keywords

Abdominal bloating; Abdominal discomfort; Abdominal pain; Guanylate cyclase type C receptor; Guanylin; MD 1100

Indexed keywords

LINACLOTIDE; PLACEBO;

ABDOMINAL PAIN; ABDOMINAL PAIN CRITERIA; ARTICLE; CLINICAL EVALUATION; COMPLETE SPONTANEOUS BOWEL MOVEMENT RATING; CONSTIPATION; DIAGNOSTIC ACCURACY; DISEASE SEVERITY; FOOD AND DRUG ADMINISTRATION RESPONDER ENDPOINT; HUMAN; INTESTINE MOTILITY; IRRITABLE COLON; META ANALYSIS; PATIENT RATING OF CHANGE QUESTIONS RATING; PERFORMANCE; PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RATING SCALE; SELF CONCEPT; SENSITIVITY AND SPECIFICITY;

EID: 84878015362     PISSN: 13501925     EISSN: 13652982     Source Type: Journal    
DOI: 10.1111/nmo.12089     Document Type: Article

References (16)

1. Hungin AP, Whorwell PJ, Tack J, Mearin F. The prevalence, patterns and impact of irritable bowel syndrome: an international survey of 40, 000 subjects. Aliment Pharmacol Ther 2003; 17: 643-50.
2. Lovell RM, Ford AC. Global prevalence of, and risk factors for, irritable bowel syndrome: a meta-analysis. Clin Gastroenterol Hepatol 2012; 10: 712-21.
3. Drossman DA, Camilleri M, Mayer EA, Whitehead WE. AGA technical review on irritable bowel syndrome. Gastroenterology 2002; 123: 2108-31.
4. Longstreth GF, Thompson WG, Chey WD, Houghton LA, Mearin F, Spiller RC. Functional bowel disorders. Gastroenterology 2006; 130: 1480-91.
5. Chang L, Heitkemper MM. Gender differences in irritable bowel syndrome. Gastroenterology 2002; 123: 1686-701.
6. Cash BD, Chey WD. Irritable bowel syndrome - an evidence-based approach to diagnosis. Aliment Pharmacol Ther 2004; 19: 1235-45.
7. Mayer EA. Clinical practice: irritable bowel syndrome. N Engl J Med 2008; 358: 1692-9.
8. U.S.Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER). Guidance for industry: irritable bowel syndrome - clinical evaluation of drugs for treatment. 2012.
9. Rao S, Lembo AJ, Shiff SJ et al. A 12-week, randomized, controlled trial with a 4-week randomized withdrawal period to evaluate the efficacy and safety of linaclotide in irritable bowel syndrome with constipation. Am J Gastroenterol 2012; 107: 1714-24.
10. Chey WD, Lembo AJ, Lavins BJ et al. Linaclotide for irritable bowel syndrome with constipation: a 26-week, randomized, double-blind, placebo-controlled trial to evaluate efficacy and safety. Am J Gastroenterol 2012; 107: 1702-12.
11. Jaeschke R, Singer J, Guyatt GH. Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials 1989; 10: 407-15.
12. McLeod LD, Coon CD, Martin SA, Fehnel SE, Hays RD. Interpreting patient-reported outcome results: US FDA guidance and emerging methods. Expert Rev Pharmacoecon Outcomes Res 2011; 11: 163-9.
13. Crosby RD, Kolotkin RL, Williams GR. Defining clinically meaningful change in health-related quality of life. J Clin Epidemiol 2003; 56: 395-407.
14. Littell RC, Milliken GA, Stroup WW, Wolfinger RD. SAS System for Mixed Models. Cary, NC: SAS Institute Inc, 1996.
15. McDowell Ian. Measuring Health - A Guide to Rating Scales and Questionnaires. New York, NY: Oxford University Press, 2006. 3.
16. Spiegel B, Bolus R, Harris LA et al. Measuring irritable bowel syndrome patient-reported outcomes with an abdominal pain numeric rating scale. Aliment Pharmacol Ther 2009; 30: 1159-70.