Evaluation of the Effectiveness, Compliance of Ibuprofen in a Sustained Release Form in the Treatment of Egyptian Osteoarthritic Patients
16 de septiembre de 2013 actualizado 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
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 estudio
De observación
Inscripción (Actual)
519
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Alexandria, Egipto
- Site Reference ID/Investigator# 42584
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Alexandria, Egipto
- Site Reference ID/Investigator# 42585
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Alexandria, Egipto
- Site Reference ID/Investigator# 42591
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Alexandria, Egipto
- Site Reference ID/Investigator# 42593
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Alexandria, Egipto
- Site Reference ID/Investigator# 42594
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Cairo, Egipto
- Site Reference ID/Investigator# 29755
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Cairo, Egipto
- Site Reference ID/Investigator# 42582
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Cairo, Egipto
- Site Reference ID/Investigator# 42583
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Cairo, Egipto
- Site Reference ID/Investigator# 42586
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Cairo, Egipto
- Site Reference ID/Investigator# 42587
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Cairo, Egipto
- Site Reference ID/Investigator# 42588
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Cairo, Egipto
- Site Reference ID/Investigator# 42589
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Cairo, Egipto
- Site Reference ID/Investigator# 42590
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Cairo, Egipto
- Site Reference ID/Investigator# 42592
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Cairo, Egipto
- Site Reference ID/Investigator# 42595
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
Primary care clinics
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Osteoarthritic patients
Patients male or female, age ≥ 18 having clinical or radiological evidence of osteoarthritis
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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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.
Periodo de tiempo: Baseline and 4 weeks
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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.
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Baseline and 4 weeks
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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).
Periodo de tiempo: 4 weeks
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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.
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4 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Percent of Participant Compliance
Periodo de tiempo: 2 and 4 weeks
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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).
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2 and 4 weeks
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Number of Participants With Joint Tenderness/Stiffness at Each Visit
Periodo de tiempo: Baseline, 2 weeks, and 4 weeks
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Joint tenderness/stiffness was measured using a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) at each visit.
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Baseline, 2 weeks, and 4 weeks
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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).
Periodo de tiempo: 2 and 4 weeks
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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.
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2 and 4 weeks
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Duration of Morning Stiffness
Periodo de tiempo: Baseline, 2 weeks, and 4 weeks
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The duration of morning stiffness in minutes was assessed at each visit.
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Baseline, 2 weeks, and 4 weeks
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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)
Periodo de tiempo: 2 and 4 weeks
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The number of participants who achieved an 80% reduction from baseline in morning stiffness was calculated at each visit.
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2 and 4 weeks
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Number of Participants With the Ability to Carry Out Normal Activities at Each Visit
Periodo de tiempo: Baseline, 2 weeks, and 4 weeks
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The number of participants who were able or unable to carry out normal activities was assessed at each visit.
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Baseline, 2 weeks, and 4 weeks
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Number of Participants Who Experienced Adverse Events and Serious Adverse Events
Periodo de tiempo: Baseline to 4 weeks
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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.
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Baseline to 4 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de junio de 2010
Finalización primaria (Actual)
1 de noviembre de 2010
Finalización del estudio (Actual)
1 de noviembre de 2010
Fechas de registro del estudio
Enviado por primera vez
7 de septiembre de 2010
Primero enviado que cumplió con los criterios de control de calidad
20 de octubre de 2010
Publicado por primera vez (Estimar)
21 de octubre de 2010
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
20 de septiembre de 2013
Última actualización enviada que cumplió con los criterios de control de calidad
16 de septiembre de 2013
Última verificación
1 de enero de 2012
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- P12-162
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .