Evaluation of the Effectiveness, Compliance of Ibuprofen in a Sustained Release Form in the Treatment of Egyptian Osteoarthritic Patients
16 de setembro de 2013 atualizado por: Abbott
A Prospective, Multi-center, Post-marketing Observational Study to Evaluate the Effectiveness and Compliance of Ibuprofen in a Sustained Release Form in the Treatment of Egyptian Osteoarthritic Patients
This is a prospective, multi-center, post-marketing observational study to evaluate the effectiveness and compliance of ibuprofen in a sustained release form in the treatment of Egyptian osteoarthritic patients.
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
This was a prospective, longitudinal, multicenter observational study conducted in a clinical practice setting where the study product was used in osteoarthritis patients as indicated in the approved package insert; the dosing regimen of Brufen retard is 2 tablets as a single dose once daily.
Tipo de estudo
Observacional
Inscrição (Real)
519
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
-
Alexandria, Egito
- Site Reference ID/Investigator# 42584
-
Alexandria, Egito
- Site Reference ID/Investigator# 42585
-
Alexandria, Egito
- Site Reference ID/Investigator# 42591
-
Alexandria, Egito
- Site Reference ID/Investigator# 42593
-
Alexandria, Egito
- Site Reference ID/Investigator# 42594
-
Cairo, Egito
- Site Reference ID/Investigator# 29755
-
Cairo, Egito
- Site Reference ID/Investigator# 42582
-
Cairo, Egito
- Site Reference ID/Investigator# 42583
-
Cairo, Egito
- Site Reference ID/Investigator# 42586
-
Cairo, Egito
- Site Reference ID/Investigator# 42587
-
Cairo, Egito
- Site Reference ID/Investigator# 42588
-
Cairo, Egito
- Site Reference ID/Investigator# 42589
-
Cairo, Egito
- Site Reference ID/Investigator# 42590
-
Cairo, Egito
- Site Reference ID/Investigator# 42592
-
Cairo, Egito
- Site Reference ID/Investigator# 42595
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra Não Probabilística
População do estudo
Primary care clinics
Descrição
Inclusion Criteria:
- Patients seeking treatment for osteoarthritis and there are clinical or radiological evidence of the disease,
- Male or female, age ≥ 18
- Designated to treatment with Ibuprofen in a sustained release form (Brufen Retard) according to the best criterion of the physician and if he decides to treat the patient according to labeled indication and dose for 4 weeks.
- Patients who have given their written informed consent to participate in the study
- Patients who are currently taking non steroidal anti inflammatory drugs (NSAIDs), should complete an initial washout phase 10 days depending on the half life of the drug taken
Exclusion Criteria:
- Contraindications as described in company core data sheet (CCDS) and specifically
- Patients with active peptic ulcer
- Patients who have presented reactions of hypersensitivity (asthma , rhinitis or urticaria ) with ibuprofen or other anti-inflammatory non steroids
- Patients with active cardiovascular disease and those taking aspirin/warfarin for prophylaxis for myocardial infarction (MI) or stroke
- Patients with moderate to severe renal diseases
- Patients with moderate to severe hepatic disease
- Patients with Crohn's disease
- Patients included currently in another study
- Women of childbearing potential must not be pregnant
- Any patients the investigators consider ineligible for this study
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
|---|
|
Osteoarthritic patients
Patients male or female, age ≥ 18 having clinical or radiological evidence of osteoarthritis
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Day and Night Mean Pain Score for the Previous 24 Hours on a Nine-point Scale (0 = no Pain to 8 = Very Severe Pain) at Visit 3 (4 Weeks Following Treatment) in Comparison to Baseline.
Prazo: Baseline and 4 weeks
|
Scoring of day and night pain for the previous 24 hours was performed on a nine-point scale (0 = no pain to 8 = very severe pain) at each visit and compared to baseline.
The overall mean pain score was calculated for participants who completed the study at each visit.
|
Baseline and 4 weeks
|
|
Number of Participants Who Improved (Reduced Pain), Had no Change (Equal Scores at Baseline and Visit), and Worsened (Increased Pain) at Visit 3 (After 4 Weeks of Treatment).
Prazo: 4 weeks
|
Scoring of day and night pain for the previous 24 hours was performed on a 9-point scale (0 = no pain to 8 = very severe pain) at each visit.
The number of participants at Visit 3 (after 4 weeks of treatment) who improved (had reduced pain; from higher baseline score to lower Visit 3 score), had no change (equal scores at baseline and Visit 3), and worsened (increased pain; from lower baseline score to higher Visit 3 score) was calculated.
|
4 weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Percent of Participant Compliance
Prazo: 2 and 4 weeks
|
The frequency with which the participant forgot to take treatment or changed dose/administration was determined by comparing the actual number of tablets taken by the participant to the scheduled number of tablets since the last visit.
Results are presented in percent (0 - 100% scale, with 100% being perfect compliance and 0% being no compliance at all).
|
2 and 4 weeks
|
|
Number of Participants With Joint Tenderness/Stiffness at Each Visit
Prazo: Baseline, 2 weeks, and 4 weeks
|
Joint tenderness/stiffness was measured using a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) at each visit.
|
Baseline, 2 weeks, and 4 weeks
|
|
Number of Participants Who Improved (Reduced), Had no Change (Equal at Baseline and Visit), and Worsened (Increased) in Joint Tenderness/Stiffness at Visit 2 (After 2 Weeks of Treatment) and Visit 3 (After 4 Weeks of Treatment).
Prazo: 2 and 4 weeks
|
Duration of morning stiffness at each visit was assessed and the number of participants who improved, had no change, or worsened at each visit, following 2 and 4 weeks of treatment (Visit 2 and Visit 3, respectively) was calculated.
|
2 and 4 weeks
|
|
Duration of Morning Stiffness
Prazo: Baseline, 2 weeks, and 4 weeks
|
The duration of morning stiffness in minutes was assessed at each visit.
|
Baseline, 2 weeks, and 4 weeks
|
|
Number of Participants With 80% Reduction From Baseline in Duration of Morning Stiffness at Visit 2 (2 Weeks of Treatment) and Visit 3 (4 Weeks of Treatment)
Prazo: 2 and 4 weeks
|
The number of participants who achieved an 80% reduction from baseline in morning stiffness was calculated at each visit.
|
2 and 4 weeks
|
|
Number of Participants With the Ability to Carry Out Normal Activities at Each Visit
Prazo: Baseline, 2 weeks, and 4 weeks
|
The number of participants who were able or unable to carry out normal activities was assessed at each visit.
|
Baseline, 2 weeks, and 4 weeks
|
|
Number of Participants Who Experienced Adverse Events and Serious Adverse Events
Prazo: Baseline to 4 weeks
|
Tolerability was assessed by collecting adverse events during the course of the study up to 30 days following the last dose of Brufen Retard.
The number of participants experiencing a serious or non-serious adverse event is summarized.
See the Reported Adverse Event section for details.
|
Baseline to 4 weeks
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de junho de 2010
Conclusão Primária (Real)
1 de novembro de 2010
Conclusão do estudo (Real)
1 de novembro de 2010
Datas de inscrição no estudo
Enviado pela primeira vez
7 de setembro de 2010
Enviado pela primeira vez que atendeu aos critérios de CQ
20 de outubro de 2010
Primeira postagem (Estimativa)
21 de outubro de 2010
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
20 de setembro de 2013
Última atualização enviada que atendeu aos critérios de controle de qualidade
16 de setembro de 2013
Última verificação
1 de janeiro de 2012
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- P12-162
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .