To Evaluate the Safety and Efficacy of Acetaminophen 650 mg and 1000mg in Dental Pain After Surgery
26 april 2012 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
540
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Utah
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Salt Lake City, Utah, Verenigde Staten, 84124
- Jean Brown Research
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
16 jaar tot 50 jaar (Kind, Volwassen)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: ACE-1000
1000 mg Acetaminophen Caplet
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Acetaminophen Caplet - single dose
Andere namen:
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Actieve vergelijker: ACE-650
650 mg Acetaminophen Caplet
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Acetaminophen Caplet - single dose
Andere namen:
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Placebo-vergelijker: ACE-0
0 mg Acetaminophen Caplet
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0 mg Caplet - single dose
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Overall Analgesic Efficacy - Sum of Pain Intensity Difference and Pain Relief Scores Over Six Hours (SPRID6)
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Sum of Pain Intensity Difference Over Six Hours (SPID6)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.
|
45 Minutes
|
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Pain Intensity Difference (PID) at 60 Minutes
Tijdsspanne: 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
Tijdsspanne: 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.
|
75 Minutes
|
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Pain Intensity Difference (PID) at 90 Minutes
Tijdsspanne: 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
Tijdsspanne: 120 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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120 Minutes
|
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Pain Intensity Difference (PID) at 180 Minutes
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.
|
300 Minutes
|
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Pain Intensity Difference (PID) at 360 Minutes
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 240 Minutes
|
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
Tijdsspanne: 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
|
300 Minutes
|
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Pain Relief (PAR) Scores at 360 Minutes
Tijdsspanne: 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
|
360 Minutes
|
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Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 15 Minutes
Tijdsspanne: 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
Tijdsspanne: 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
|
|
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 45 Minutes
Tijdsspanne: 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
Tijdsspanne: 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
|
|
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 75 Minutes
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Studie directeur: Daniel Qi, M.D., McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 juni 2010
Primaire voltooiing (Werkelijk)
1 januari 2011
Studie voltooiing (Werkelijk)
1 januari 2011
Studieregistratiedata
Eerst ingediend
30 april 2010
Eerst ingediend dat voldeed aan de QC-criteria
3 mei 2010
Eerst geplaatst (Schatting)
4 mei 2010
Updates van studierecords
Laatste update geplaatst (Schatting)
28 mei 2012
Laatste update ingediend die voldeed aan QC-criteria
26 april 2012
Laatst geverifieerd
1 april 2012
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- ACEPAI2001
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .