To Evaluate the Safety and Efficacy of Acetaminophen 650 mg and 1000mg in Dental Pain After Surgery
26 de abril de 2012 actualizado por: McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Safety and Efficacy Study of Acetaminophen 1000 mg and Acetaminophen 650 mg in Post Operative Dental Pain
The objective of this study is to evaluate the safety and efficacy of acetaminophen 650 mg and acetaminophen 1000 mg in dental surgery.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
This trial is to assess the relative efficacy of acetaminophen 1000 mg versus acetaminophen 650 mg over a six-hour period, in subjects experiencing at least moderate post-operative dental pain.
Tipo de estudio
Intervencionista
Inscripción (Actual)
540
Fase
- Fase 3
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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Utah
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Salt Lake City, Utah, Estados Unidos, 84124
- Jean Brown Research
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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
16 años a 50 años (Niño, Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Must be at least 16 and less than 51 years of age
- Must weigh at least 100 lbs with a body mass index of at least 18 and less than 30
- Must have up to four of their back teeth (third-molars) pulled
Exclusion Criteria:
- Cannot be allergic to acetaminophen (Tylenol)
- Cannot be pregnant (or planning to be pregnant) or nursing a baby
- Cannot have any other medical conditions that the investigator determines might compromise your safety or the study results
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
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: ACE-1000
1000 mg Acetaminophen Caplet
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Acetaminophen Caplet - single dose
Otros nombres:
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Comparador activo: ACE-650
650 mg Acetaminophen Caplet
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Acetaminophen Caplet - single dose
Otros nombres:
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Comparador de placebos: ACE-0
0 mg Acetaminophen Caplet
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0 mg Caplet - single dose
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Overall Analgesic Efficacy - Sum of Pain Intensity Difference and Pain Relief Scores Over Six Hours (SPRID6)
Periodo de tiempo: 6 Hours
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Weighted Sum of Pain Intensity Difference and Pain Relief Scores Over Six Hours (SPRID6) - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief.
For SPRID6, the total possible minimum value is -300 (worst) and the total possible maximum value is 1200 (best).
The weights used in the calculation of weighted sums were equal to the elapsed time (hour) between the time point of interest and the preceding time point.
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6 Hours
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Sum of Pain Intensity Difference Over Six Hours (SPID6)
Periodo de tiempo: 6 Hours
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Weighted Sum of the Pain Intensity Difference from Baseline Over Six Hours (SPID6) - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain.
The total possible minimum value is -300 (worst) and the total possible maximum value is 600 (best).
The weights used in the calculation of weighted sums were equal to the elapsed time (hour) between the time point of interest and the preceding time point.
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6 Hours
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Sum of Pain Relief Scores Over Six Hours (TOTPAR6)
Periodo de tiempo: 6 Hours
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Weighted Sum of the Pain Relief Scores Over Six Hours (TOTPAR6) - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief.
The total possible minimum value is 0 (worst) and the total possible maximum value is 600 (best).
The weights used in the calculation of weighted sums were equal to the elapsed time (hour) between the time point of interest and the preceding time point.
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6 Hours
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Pain Intensity Difference (PID) at 15 Minutes
Periodo de tiempo: 15 Minutes
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Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100.
The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.
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15 Minutes
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Pain Intensity Difference (PID) at 30 Minutes
Periodo de tiempo: 30 Minutes
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Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100.
The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.
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30 Minutes
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Pain Intensity Difference (PID) at 45 Minutes
Periodo de tiempo: 45 Minutes
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Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100.
The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.
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45 Minutes
|
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Pain Intensity Difference (PID) at 60 Minutes
Periodo de tiempo: 60 Minutes
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Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100.
The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.
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60 Minutes
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Pain Intensity Difference (PID) at 75 Minutes
Periodo de tiempo: 75 Minutes
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Pain Intensity Difference (PID) from Baseline at Each Assessment Time Point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100.
The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.
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75 Minutes
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Pain Intensity Difference (PID) at 90 Minutes
Periodo de tiempo: 90 Minutes
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Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100.
The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.
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90 Minutes
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Pain Intensity Difference (PID) at 120 Minutes
Periodo de tiempo: 120 Minutes
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Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100.
The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.
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120 Minutes
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Pain Intensity Difference (PID) at 180 Minutes
Periodo de tiempo: 180 Minutes
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Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100.
The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.
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180 Minutes
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Pain Intensity Difference (PID) at 240 Minutes
Periodo de tiempo: 240 Minutes
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Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100.
The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.
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240 Minutes
|
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Pain Intensity Difference (PID) at 300 Minutes
Periodo de tiempo: 300 Minutes
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Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100.
The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.
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300 Minutes
|
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Pain Intensity Difference (PID) at 360 Minutes
Periodo de tiempo: 360 Minutes
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Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100.
The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.
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360 Minutes
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Pain Relief (PAR) Scores at 15 Minutes
Periodo de tiempo: 15 Minutes
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Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100
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15 Minutes
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Pain Relief (PAR) Scores at 30 Minutes
Periodo de tiempo: 30 Minutes
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Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100
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30 Minutes
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Pain Relief (PAR) Scores at 45 Minutes
Periodo de tiempo: 45 Minutes
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Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100
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45 Minutes
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Pain Relief (PAR) Scores at 60 Minutes
Periodo de tiempo: 60 Minutes
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Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100
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60 Minutes
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Pain Relief (PAR) Scores at 75 Minutes
Periodo de tiempo: 75 Minutes
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Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100
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75 Minutes
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Pain Relief (PAR) Scores at 90 Minutes
Periodo de tiempo: 90 Minutes
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Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100
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90 Minutes
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Pain Relief (PAR) Scores at 120 Minutes
Periodo de tiempo: 120 Minutes
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Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100
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120 Minutes
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Pain Relief (PAR) Scores at 180 Minutes
Periodo de tiempo: 180 Minutes
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Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100
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180 Minutes
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Pain Relief (PAR) Scores at 240 Minutes
Periodo de tiempo: 240 Minutes
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Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100
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240 Minutes
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Pain Relief (PAR) Scores at 300 Minutes
Periodo de tiempo: 300 Minutes
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Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100
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300 Minutes
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Pain Relief (PAR) Scores at 360 Minutes
Periodo de tiempo: 360 Minutes
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Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100
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360 Minutes
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Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 15 Minutes
Periodo de tiempo: 15 Minutes
|
Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief
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15 Minutes
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Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 30 Minutes
Periodo de tiempo: 30 Minutes
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Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief
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30 Minutes
|
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Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 45 Minutes
Periodo de tiempo: 45 Minutes
|
Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief
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45 Minutes
|
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Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 60 Minutes
Periodo de tiempo: 60 Minutes
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Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief
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60 Minutes
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Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 75 Minutes
Periodo de tiempo: 75 Minutes
|
Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief
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75 Minutes
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Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 90 Minutes
Periodo de tiempo: 90 Minutes
|
Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief
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90 Minutes
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Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 120 Minutes
Periodo de tiempo: 120 Minutes
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Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief
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120 Minutes
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Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 180 Minutes
Periodo de tiempo: 180 Minutes
|
Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief
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180 Minutes
|
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Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 240 Minutes
Periodo de tiempo: 240 Minutes
|
Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief
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240 Minutes
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Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 300 Minutes
Periodo de tiempo: 300 Minutes
|
Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief
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300 Minutes
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Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 360 Minutes
Periodo de tiempo: 360 Minutes
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Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief
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360 Minutes
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Time to Meaningful Pain Relief
Periodo de tiempo: within 6 Hours
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Minutes until meaningful pain relief was achieved.
A stopwatch was provided to the subject after ingestion of the study medication.
The subject was instructed to stop the stopwatch when the relief from the starting pain was meaningful to them.
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within 6 Hours
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Time to Confirmed Perceptible Pain Relief
Periodo de tiempo: within 6 Hours
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Minutes until confirmed perceptible pain relief was achieved.
A stopwatch was provided to the subject after ingestion of the study medication.
The subject was instructed to stop the stopwatch when they first began to feel any pain relieving effect whatsoever of the drug, that was when they first felt any pain relief.
It did not necessarily mean they felt completely better, although they might have, but when they first felt any difference in the pain.
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within 6 Hours
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Duration of Analgesia - Time to Rescue
Periodo de tiempo: within 6 Hours
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Minutes until rescue medication was given.
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within 6 Hours
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Rescue Rates Through Four Hours
Periodo de tiempo: through 4 Hours
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Percentage of subjects using rescue medication.
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through 4 Hours
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Rescue Rates Through Six Hours
Periodo de tiempo: through 6 Hours
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Percentage of subjects using rescue medication.
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through 6 Hours
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Percentage of Subjects With >50% of the Maximum Possible TOTPAR6 Score
Periodo de tiempo: 6 Hours
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Percentage of Subjects with >50% of the Maximum Possible TOTPAR6 Score - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 600 so >50% is >300 out of 600
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6 Hours
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Patient Global Evaluation
Periodo de tiempo: 6 Hours
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Patient Assessment of the Pain Medication - Number of Subjects rating the medication they received as a pain reliever on a score of 0-4, where 0=poor, 1=fair, 2=good, 3=very good, 4=excellent
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6 Hours
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Investigadores
- Director de estudio: Daniel Qi, M.D., McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el 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 enero de 2011
Finalización del estudio (Actual)
1 de enero de 2011
Fechas de registro del estudio
Enviado por primera vez
30 de abril de 2010
Primero enviado que cumplió con los criterios de control de calidad
3 de mayo de 2010
Publicado por primera vez (Estimar)
4 de mayo de 2010
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
28 de mayo de 2012
Última actualización enviada que cumplió con los criterios de control de calidad
26 de abril de 2012
Última verificación
1 de abril de 2012
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ACEPAI2001
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. .
Ensayos clínicos sobre Acetaminophen
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Janssen Korea, Ltd., KoreaTerminado
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Stanford UniversityMayo Clinic; University of British Columbia; Albert Einstein College of Medicine; Vanderbilt University Medical Center y otros colaboradoresTerminadoDolor | Dolor Postoperatorio | Sinusitis | Uso de opioides | Abuso de opioides | Uso de narcóticos | Enfermedad OtorrinolaringológicaEstados Unidos, Canadá