To Evaluate the Safety and Efficacy of Acetaminophen 650 mg and 1000mg in Dental Pain After Surgery
26 de abril de 2012 atualizado 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
Inscrição (Real)
540
Estágio
- Fase 3
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
-
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Utah
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Salt Lake City, Utah, Estados Unidos, 84124
- Jean Brown Research
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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
16 anos a 50 anos (Filho, Adulto)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
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
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: ACE-1000
1000 mg Acetaminophen Caplet
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Acetaminophen Caplet - single dose
Outros nomes:
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Comparador Ativo: ACE-650
650 mg Acetaminophen Caplet
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Acetaminophen Caplet - single dose
Outros nomes:
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Comparador de Placebo: ACE-0
0 mg Acetaminophen Caplet
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0 mg Caplet - single dose
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Overall Analgesic Efficacy - Sum of Pain Intensity Difference and Pain Relief Scores Over Six Hours (SPRID6)
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Sum of Pain Intensity Difference Over Six Hours (SPID6)
Prazo: 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)
Prazo: 6 Hours
|
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
Prazo: 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
Prazo: 30 Minutes
|
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
Prazo: 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
Prazo: 60 Minutes
|
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
Prazo: 75 Minutes
|
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
Prazo: 90 Minutes
|
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
Prazo: 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
Prazo: 180 Minutes
|
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
Prazo: 240 Minutes
|
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
Prazo: 300 Minutes
|
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
Prazo: 360 Minutes
|
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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
15 Minutes
|
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Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 30 Minutes
Prazo: 30 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
|
30 Minutes
|
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Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 45 Minutes
Prazo: 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
|
45 Minutes
|
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Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 60 Minutes
Prazo: 60 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
|
60 Minutes
|
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Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 75 Minutes
Prazo: 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
|
75 Minutes
|
|
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 90 Minutes
Prazo: 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
|
90 Minutes
|
|
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 120 Minutes
Prazo: 120 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
|
120 Minutes
|
|
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 180 Minutes
Prazo: 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
|
180 Minutes
|
|
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 240 Minutes
Prazo: 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
|
240 Minutes
|
|
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 300 Minutes
Prazo: 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
|
300 Minutes
|
|
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 360 Minutes
Prazo: 360 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
|
360 Minutes
|
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Time to Meaningful Pain Relief
Prazo: within 6 Hours
|
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
Prazo: within 6 Hours
|
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
Prazo: within 6 Hours
|
Minutes until rescue medication was given.
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within 6 Hours
|
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Rescue Rates Through Four Hours
Prazo: through 4 Hours
|
Percentage of subjects using rescue medication.
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through 4 Hours
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Rescue Rates Through Six Hours
Prazo: 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
Prazo: 6 Hours
|
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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Investigadores
- Diretor de estudo: Daniel Qi, M.D., McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
Publicações e links úteis
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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 janeiro de 2011
Conclusão do estudo (Real)
1 de janeiro de 2011
Datas de inscrição no estudo
Enviado pela primeira vez
30 de abril de 2010
Enviado pela primeira vez que atendeu aos critérios de CQ
3 de maio de 2010
Primeira postagem (Estimativa)
4 de maio de 2010
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
28 de maio de 2012
Última atualização enviada que atendeu aos critérios de controle de qualidade
26 de abril de 2012
Última verificação
1 de abril de 2012
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- ACEPAI2001
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 .
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