Mean Responses on PGI-Improvement Primary Endpoint at Week 12

Slides:



Advertisements
Similar presentations
Asthma Trial – a double blinded, randomized, placebo-controlled study Team Moser: Jing Dong Yan Yan Wu Haipeng Yao.
Advertisements

Data Supplement RIO-Europe RIO-Lipids RIO-Diabetes RIO-North America European labeling.
Differences in Patterns of Impairment, Psychiatric Comorbidity and Headache Beliefs in Migraine and Chronic Tension-type Headache Kathleen M. Romanek M.S.,
Clinical Trial Results. org The Canadian Cardiac Randomized Evaluation of Antidepressant and Psychotherapy Efficacy (CREATE) Trial François Lespérance,
Design: A randomized, prospective, double-blind cohort followed for 16 weeks RenehaVis Original Study 50 DMW 50 HMW 50 LMW 50 Placebo.
Switch NNRTI to NNRTI  Switch EFV to ETR –CNS toxicity study –Patient’s preference study.
Efficacy and Safety of Memantine in Patients With Mild to Moderate Vascular Dementia A Randomized, Placebo-controlled Trial (MMM 300) Orgogozo J.M., Rigaud.
Exam 2 Review. Example Information A researcher wants to know if using their flashcard program increases the number of items an individual can memorize.
Journal of the American Medical Association (JAMA), 2004, 291:
Treatment month Adjusted mean change in IPSS from baseline (ITT, LOCF) Tamsulosin
Supplemental Figure Legends Supplemental Figure 1a: SF-36. SF-36 mental component score among subjects randomized to SAMe or placebo, at baseline, Week.
Tetrabenazine (Xenazine ® ) Prestwick Pharmaceuticals NDA Peripheral and Central Nervous System Drugs Advisory Committee Meeting Beltsville, Maryland.
Chapter 11: The t Test for Two Related Samples. Related t Formulas.
Effects of Memantine on behavioural symptoms in Alzheimer’s disease patients: an analysis of the Neuropsychiatric Inventory (NPI) data of two randomised,
Differences in Fatigue and Depressive Symptoms Between Long and Average Sleeping Older Adults Introduction Methods Results Discussion Support Major Depressive.
School of Allied Health Professions & School of Medicine, Health Policy & Practice LAMP A pragmatic unblinded randomised controlled trial and economic.
Date of download: 6/24/2016 Copyright © 2016 American Medical Association. All rights reserved. From: Aripiprazole, an Antipsychotic With a Novel Mechanism.
1 Statistical Issues in NDA Laura Lu, Ph.D FDA/CDER.
Copyright © 2013 American Medical Association. All rights reserved.
Sofija Zagarins1, PhD, Garry Welch1, PhD, Jane Garb2, MS
CONCLUSIONS AND DISCUSSION
Copyright © 2010 American Medical Association. All rights reserved.
A Randomized, Placebo-Controlled Trial of OROS Methylphenidate in Adults with Attention-Deficit/Hyperactivity Disorder  Joseph Biederman, Eric Mick, Craig.
Figure 1. Raw mean scores of the MFI subscales ‘mental fatigue’ and ‘reduction in motivation’ (range 4–20, the higher the score the more mental fatigue.
PICO Amanda DiMaria.
Efficacy of escitalopram in the treatment of social anxiety disorder: A meta-analysis versus placebo  David S. Baldwin, Satoshi Asakura, Tsukasa Koyama,
Copyright © 2015 by the American Osteopathic Association.
Theoretical Background Conclusions & Future Directions
Copyright © 2002 American Medical Association. All rights reserved.
Copyright © 2003 American Medical Association. All rights reserved.
Copyright © 2013 American Medical Association. All rights reserved.
Neal B, et al. Diabetes Care 2015;38:403–411
Copyright © 2004 American Medical Association. All rights reserved.
Copyright © 2003 American Medical Association. All rights reserved.
Effect of Linaclotide on Severe Abdominal Symptoms in Patients With Irritable Bowel Syndrome With Constipation  Satish S.C. Rao, Eamonn M.M. Quigley,
PASI responder rates (A, B) and total resolution in (C) nail psoriasis, (D) enthesitis and (E) dactylitis in affected patients receiving CZP from Week.
Effect of Linaclotide on Severe Abdominal Symptoms in Patients With Irritable Bowel Syndrome With Constipation  Satish S.C. Rao, Eamonn M.M. Quigley,
Can Primary Care Physicians Take the Lead in Combating Obesity?
Efficacy and safety of naproxcinod in the treatment of patients with osteoarthritis of the knee: a 13-week prospective, randomized, multicenter study 
Patients included in linear extrapolation and observed/last observation carried forward analyses at week 48. Patients who were rescued or discontinued.
N3-378 Template 12/31/2018 7:52 PM 8 8.
An Introductory Tutorial
Antidepressant Therapy in Patients Undergoing Coronary Artery Bypass Grafting: The MOTIV-CABG Trial  Sidney Chocron, MD, PhD, Pierre Vandel, MD, PhD,
Mean ADHD-RS-IV Scores at End Point
Once-Daily Gastroretentive Gabapentin for Postherpetic Neuralgia: Integrated Efficacy, Time to Onset of Pain Relief and Safety Analyses of Data From Two.
Proportion of Patients Achieving a ≥30% Reduction in Pain Scores at Week 12 of Stable Dose Treatment
FX006 Pivotal Ph 2b Data September , 2015
AGENT III: 12 week results
Ranolazine in Microvascular Dysfunction
Apremilast, an oral phosphodiesterase 4 inhibitor, in patients with difficult-to-treat nail and scalp psoriasis: Results of 2 phase III randomized, controlled.
OSLER Trial design: Patients from five phase 2 trials and seven phase 3 trials with evolocumab were invited to participate in the OSLER extension program,
Volume 151, Issue 6, Pages (December 2016)
Impact of intensified pharmaceutical care on health related quality of life in patients with stroke in a tertiary care hospital  Dilip Chandrasekhar,
Effects of reslizumab on asthma control questionnaire-7 (ACQ-7) score in Global Initiative for Asthma (GINA) Step 4 and 5 patients. Effects of reslizumab.
Efficacy and safety of duloxetine in Chinese patients with chronic pain due to osteoarthritis: a randomized, double-blind, placebo-controlled study  G.
by Isobel M Cameron, Kenneth Lawton, and Ian C Reid
Volume 132, Issue 1, Pages (January 2007)
Patient-reported outcomes: proportion of patients with clinically meaningful improvements in (A) SF-36 PCS and MCS at Week 52 and Week 104*†‡ and (B) HAQ-DI.
Impact of intensified pharmaceutical care on health related quality of life in patients with stroke in a tertiary care hospital  Dilip Chandrasekhar,
Ulrich Mrowietz, MD, Hervé Bachelez, MD, PhD, A
Percentages of patients reporting improvements from baseline ≥minimum clinically important difference (MCID) and number needed to treat (NNT) in (A) patient-reported.
Changes in glycated hemoglobin (HbA1c) levels after 12 weeks’ treatment with lixisenatide (according to dose increase regimen) or placebo. Changes in glycated.
Fig. 2. Efficacy endpoints among treatment groups: least square (LS) mean changes from baseline in the WOMAC-pain subscale (A), total WOMACOA index score.
Mean change from baseline over time in BILAG score,
FIM total score by study visit (ITT population).
Clinical responses to therapy from baseline to week 24 and end point with last observation carried forward (LOCF). Clinical responses to therapy from baseline.
Dupilumab provides important clinical benefits to patients with atopic dermatitis who do not achieve clear or almost clear skin according to the Investigator’s.
Patient-reported Outcome Measures
(A) Short Health Scale (SHS) dimension scores (left) and Psychological General Well-Being Index (PGWBI) global scores (right) for the open-label phase.
Presentation transcript:

Mean Responses on PGI-Improvement Primary Endpoint at Week 12 Very much better 1 Much better 2 *** *** *** *** A little better 3 No change 4 2 4 8 12 A little worse 5 Week of Study Much worse 6 Duloxetine Placebo Very much worse 7 *** P<0.001 vs placebo PGI=Patient Global Impression. At week 12 57% of duloxetine patients who had a PGI-I score ≤2, which was significantly more than patients in the placebo group.

LOCF Mean Change from Baseline to Endpoint in MFI Subscale Scores 17.0 17.1 15.4 15.3 13.2 12.9 13.7 13.6 12.4 12.5 Improvement ** *** ** * ** Duloxetine Placebo General Fatigue Physical Fatigue Mental Fatigue Reduced Activity Reduced Motivation * P≤ 0.05; ** P≤ 0.01; *** P≤ 0.001 LOCF= last observation carried forward; MFI= Multidimensional Fatigue Inventory. There were no significant between-treatment differences at baseline.

Beck Depression Inventory Beck Anxiety Inventory LOCF Mean Change from Baseline to Endpoint in Beck Depression and Anxiety Inventories Beck Depression Inventory Beck Anxiety Inventory ** 15.8 16.3 12.4 13.3 Duloxetine Placebo Improvement Baseline: ** P<0.01 vs placebo LOCF= last observation carried forward.