Sample size recalculation in internal pilot study designs: a review

T Friede, M Kieser - Biometrical Journal: Journal of …, 2006 - Wiley Online Library
The adequacy of sample size is important to clinical trials. In the planning phase of a trial,
however, the investigators are often quite uncertain about the sizes of parameters which are …

Comparison of fixed-dose weight-adjusted unfractionated heparin and low-molecular-weight heparin for acute treatment of venous thromboembolism

C Kearon, JS Ginsberg, JA Julian, J Douketis… - Jama, 2006 - jamanetwork.com
ContextWhen unfractionated heparin is used to treat acute venous thromboembolism, it is
usually administered by intravenous infusion with coagulation monitoring, which requires …

Statistical considerations for noninferiority/equivalence trials in vaccine development

WWB Wang, DV Mehrotra, ISF Chan… - Journal of …, 2006 - Taylor & Francis
Noninferiority/equivalence designs are often used in vaccine clinical trials. The goal of these
designs is to demonstrate that a new vaccine, or new formulation or regimen of an existing …

Effects of the potency and composition of the multivalent human-bovine (WC3) reassortant rotavirus vaccine on efficacy, safety and immunogenicity in healthy infants

T Vesikari, HF Clark, PA Offit, MJ Dallas, DJ DiStefano… - Vaccine, 2006 - Elsevier
BACKGROUND: Rotavirus gastroenteritis, which causes substantial infant mortality and
morbidity worldwide, is a vaccine-preventable disease. The purpose of this study was to …

Budesonide foam versus budesonide enema in active ulcerative proctitis and proctosigmoiditis

V Gross, S BAR‐MEIR, A Lavy… - Alimentary …, 2006 - Wiley Online Library
Background Rectal budesonide is an effective treatment of active ulcerative proctitis or
proctosigmoiditis. Aim To compare the therapeutic efficacy, tolerability and safety, and …

Efficacy and safety of a combination of sabal and urtica extract in lower urinary tract symptoms

U Engelmann, C Walther, B Bondarenko… - …, 2006 - thieme-connect.com
The aim of this prospective, randomized, double-blind, double-dummy, multicenter clinical
trial was to investigate the efficacy and safety of PRO 160/120 (Prostagutt® forte), a fixed …

Clinical and bacteriological efficacy in treatment of acute exacerbations of chronic bronchitis with cefditoren-pivoxil versus cefuroxime-axetil

JL Alvarez-Sala, P Kardos… - Antimicrobial agents …, 2006 - Am Soc Microbiol
ABSTRACT A randomized, double-blind, double-dummy trial was performed comparing 200
mg of cefditoren-pivoxil twice daily for 5 days versus standard cefuroxime-axetil treatment …

Comparison of the efficacy and safety of Eudragit‐L‐coated mesalazine tablets with ethylcellulose‐coated mesalazine tablets in patients with mild to moderately active …

PR Gibson, B Fixa, B Pekarkova… - Alimentary …, 2006 - Wiley Online Library
Background There are no comparative studies of coated mesalazine. Aim To compare the
efficacy and tolerability of Eudragit‐L‐and ethylcellulose‐coated mesalazine tablets in …

Retapamulin ointment twice daily for 5 days vs oral cephalexin twice daily for 10 days for empiric treatment of secondarily infected traumatic lesions of the skin

A Free, E Roth, M Dalessandro… - … : Dermatology for the …, 2006 - Wiley Online Library
Introduction: Retapamulin is a novel, topical antibacterial of the pleuromutilin class in
development for the treatment of secondarily infected traumatic lesions of the skin. Methods …

The effects of non‐compliance on intent‐to‐treat analysis of equivalence trials

D Sheng, MY Kim - Statistics in medicine, 2006 - Wiley Online Library
The standard approach for analysing a randomized clinical trial is based on intent‐to‐treat
(ITT) where subjects are analysed according to their assigned treatment group regardless of …