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1.
Stat Biopharm Res ; 12(4): 399-411, 2020 Jul 06.
Artigo em Inglês | MEDLINE | ID: mdl-34191971

RESUMO

Abstract-The COVID-19 pandemic has had and continues to have major impacts on planned and ongoing clinical trials. Its effects on trial data create multiple potential statistical issues. The scale of impact is unprecedented, but when viewed individually, many of the issues are well defined and feasible to address. A number of strategies and recommendations are put forward to assess and address issues related to estimands, missing data, validity and modifications of statistical analysis methods, need for additional analyses, ability to meet objectives and overall trial interpretability.

2.
Artigo em Inglês | MEDLINE | ID: mdl-16182156

RESUMO

OBJECTIVE: To determine analgesic efficacy of a single oral dose of rofecoxib 50 mg compared with acetaminophen/codeine 600/60 mg, we conducted a double-blind, randomized, placebo- and active-comparator-controlled, parallel-group study. STUDY DESIGN: Patients (N = 390) experiencing moderate or severe pain postextraction of 2 or more third molars, with at least 1 mandibular impaction, were randomized to placebo (n = 30), rofecoxib (n = 180), or codeine/acetaminophen 60/600 mg (n = 180). Time to confirmed perceptible pain relief, and patient evaluations of pain intensity, pain relief, and global assessments were recorded. RESULTS: For total pain relief over 6 hours (primary end point), rofecoxib was superior to codeine/acetaminophen (15.5 vs 10.7; P < .001). Rofecoxib was statistically significantly superior to codeine/acetaminophen with respect to TOPAR4, patient global assessment, peak pain relief, and duration of analgesic effect. Median onset of analgesia was similar for both drugs. The codeine/acetaminophen group had more patients with 1 or more adverse events. CONCLUSION: Rofecoxib provided superior analgesic efficacy compared with codeine/acetaminophen with fewer gastrointestinal and nervous system adverse events.


Assuntos
Analgésicos Opioides/uso terapêutico , Codeína/uso terapêutico , Inibidores de Ciclo-Oxigenase 2/uso terapêutico , Dor Facial/tratamento farmacológico , Lactonas/uso terapêutico , Dor Pós-Operatória/tratamento farmacológico , Sulfonas/uso terapêutico , Acetaminofen/uso terapêutico , Doença Aguda , Adolescente , Adulto , Analgésicos não Narcóticos/uso terapêutico , Análise de Variância , Qualidade de Produtos para o Consumidor , Método Duplo-Cego , Combinação de Medicamentos , Dor Facial/etiologia , Feminino , Humanos , Modelos Logísticos , Masculino , Dente Serotino/cirurgia , Dor Pós-Operatória/etiologia , Extração Dentária/efeitos adversos
3.
J Clin Oncol ; 23(12): 2822-30, 2005 Apr 20.
Artigo em Inglês | MEDLINE | ID: mdl-15837996

RESUMO

PURPOSE: This is the first study in which the NK(1)-receptor antagonist, aprepitant (APR), was evaluated for the prevention of chemotherapy-induced nausea and vomiting (CINV) with moderately emetogenic chemotherapy. PATIENTS AND METHODS: Eligible breast cancer patients were naive to emetogenic chemotherapy and treated with cyclophosphamide +/- doxorubicin or epirubicin. Patients were randomly assigned to either an aprepitant regimen (day 1, APR 125 mg, ondansetron (OND) 8 mg, and dexamethasone 12 mg before chemotherapy and OND 8 mg 8 hours later; days 2 through 3, APR 80 qd) [DOSAGE ERROR CORRECTED] or a control regimen (day 1, OND 8 mg and dexamethasone 20 mg before chemotherapy and OND 8 mg 8 hours later; days 2 through 3, OND 8 mg bid). Data on nausea, vomiting, and use of rescue medication were collected with a self-report diary. The primary efficacy end point was the proportion of patients with complete response, defined as no vomiting and no use of rescue therapy, during 120 hours after initiation of chemotherapy in cycle 1. The secondary end point was the proportion of patients with an average item score higher than 6 of 7 on the Functional Living Index-Emesis questionnaire. RESULTS: Of 866 patients randomized, 857 patients (99%) were assessable. Overall complete response was greater with the aprepitant regimen than with the control regimen (50.8% v 42.5%; P = .015). More patients in the aprepitant group reported minimal or no impact of CINV on daily life (63.5% v 55.6%; P = .019). Both treatments were generally well tolerated. CONCLUSION: The aprepitant regimen was more effective than the control regimen for prevention of CINV in patients receiving both an anthracycline and cyclophosphamide.


Assuntos
Antieméticos/efeitos adversos , Antieméticos/uso terapêutico , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Neoplasias da Mama/tratamento farmacológico , Morfolinas/efeitos adversos , Morfolinas/uso terapêutico , Náusea/induzido quimicamente , Náusea/prevenção & controle , Vômito/induzido quimicamente , Vômito/prevenção & controle , Adulto , Antieméticos/farmacologia , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Aprepitanto , Ciclofosfamida/administração & dosagem , Ciclofosfamida/efeitos adversos , Dexametasona/uso terapêutico , Método Duplo-Cego , Doxorrubicina/administração & dosagem , Doxorrubicina/efeitos adversos , Epirubicina/administração & dosagem , Epirubicina/efeitos adversos , Feminino , Humanos , Pessoa de Meia-Idade , Morfolinas/farmacologia , Ondansetron/uso terapêutico
4.
J Pain ; 4(6): 307-15, 2003 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-14622687

RESUMO

We evaluated etoricoxib, a novel COX-2-specific inhibitor, in 319 patients with chronic low back pain (LBP) in this double-blind, placebo-controlled trial. Patients were randomized to a 60 mg dose (n = 103) or 90 mg dose (n = 107) of etoricoxib, or placebo (n = 109), daily for 12 weeks. The primary endpoint was low back pain intensity scale (Visual Analog Scale of 0- to 100-mm) time-weighted average change from baseline over 4 weeks. Other endpoints included evaluation over 3 months of low back pain intensity scale, Roland-Morris Disability Questionnaire (RMDQ), low back pain bothersomeness scale, patient- and investigator-global assessments, Patient Health Survey (MOS SF-12), rescue acetaminophen use, and discontinuation due to lack of efficacy. Etoricoxib provided significant improvement from baseline versus placebo in pain intensity (4 weeks: 12.9 mm and 10.3 mm for 60-mg and 90-mg doses, P <.001 for each; 12 weeks: 10.5 mm and 7.5 mm for 60-mg and 90-mg doses, P =.001 and.018, respectively). Etoricoxib at either dose led to significant improvement in other endpoints, including RMDQ scores, bothersomeness scores and global assessments. Etoricoxib given once daily provided significant relief of symptoms, and disability associated with chronic LBP that was observed 1 week after initiating therapy, was maximal at 4 weeks, and was maintained over 3 months.


Assuntos
Inibidores de Ciclo-Oxigenase/administração & dosagem , Isoenzimas/antagonistas & inibidores , Dor Lombar/tratamento farmacológico , Piridinas/administração & dosagem , Sulfonas/administração & dosagem , Adolescente , Adulto , Idoso , Doença Crônica , Ciclo-Oxigenase 2 , Inibidores de Ciclo-Oxigenase 2 , Inibidores de Ciclo-Oxigenase/efeitos adversos , Avaliação da Deficiência , Etoricoxib , Feminino , Humanos , Dor Lombar/reabilitação , Masculino , Proteínas de Membrana , Pessoa de Meia-Idade , Prostaglandina-Endoperóxido Sintases , Piridinas/efeitos adversos , Sulfonas/efeitos adversos , Resultado do Tratamento
5.
Clin Infect Dis ; 37(9): 1155-64, 2003 Nov 01.
Artigo em Inglês | MEDLINE | ID: mdl-14557958

RESUMO

To assess the efficacy of a 7-valent pneumococcal polysaccharide-meningococcal outer membrane protein complex conjugate vaccine (PncOMPC) against acute otitis media (AOM), 1666 infants were randomly assigned to receive either PncOMPC or control vaccine (hepatitis B vaccine) at 2, 4, 6, and 12 months of age. Of the 835 children assigned to receive PncOMPC, 187 received a 23-valent pneumococcal polysaccharide vaccine (PncPS) at 12 months of age instead. Whenever AOM was diagnosed, middle ear fluid was aspirated for bacterial culture. In the PncOMPC and control groups, there were 110 and 250 AOM episodes, respectively, in children between 6.5 and 24 months of age that could be attributed to vaccine serotypes, which indicates a vaccine efficacy of 56% (95% confidence interval, 44%-66%). The serotype-specific efficacy ranged from 37% for 19F to 82% for 9V. The 2 boosters seemed to provide equal protection against AOM, but PncPS induced markedly higher antibody concentrations. The efficacy of PncOMPC was comparable to that of the recently licensed pneumococcal conjugate vaccine.


Assuntos
Otite Média/prevenção & controle , Vacinas Pneumocócicas/administração & dosagem , Vacinas Conjugadas/administração & dosagem , Doença Aguda , Proteínas da Membrana Bacteriana Externa/administração & dosagem , Proteínas da Membrana Bacteriana Externa/química , Criança , Estudos de Coortes , Método Duplo-Cego , Humanos , Imunização Secundária , Lactente , Vacinas Meningocócicas/administração & dosagem , Vacinas Meningocócicas/efeitos adversos , Vacinas Meningocócicas/química , Otite Média/imunologia , Infecções Pneumocócicas/prevenção & controle , Vacinas Pneumocócicas/efeitos adversos , Vacinas Pneumocócicas/química , Streptococcus pneumoniae , Vacinas Conjugadas/efeitos adversos
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