To Evaluate the Safety and Efficacy of Acetaminophen 650 mg and 1000mg in Dental Pain After Surgery
2012. április 26. frissítette: 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.
A tanulmány áttekintése
Állapot
Befejezve
Körülmények
Beavatkozás / kezelés
Részletes leírás
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.
Tanulmány típusa
Beavatkozó
Beiratkozás (Tényleges)
540
Fázis
- 3. fázis
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi helyek
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Utah
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Salt Lake City, Utah, Egyesült Államok, 84124
- Jean Brown Research
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Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
16 év (Gyermek, Felnőtt)
Egészséges önkénteseket fogad
Nem
Tanulmányozható nemek
Összes
Leírás
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
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Kettős
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Kísérleti: ACE-1000
1000 mg Acetaminophen Caplet
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Acetaminophen Caplet - single dose
Más nevek:
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Aktív összehasonlító: ACE-650
650 mg Acetaminophen Caplet
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Acetaminophen Caplet - single dose
Más nevek:
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Placebo Comparator: ACE-0
0 mg Acetaminophen Caplet
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0 mg Caplet - single dose
Más nevek:
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Overall Analgesic Efficacy - Sum of Pain Intensity Difference and Pain Relief Scores Over Six Hours (SPRID6)
Időkeret: 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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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Sum of Pain Intensity Difference Over Six Hours (SPID6)
Időkeret: 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)
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 15 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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15 Minutes
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Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 30 Minutes
Időkeret: 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
Időkeret: 45 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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45 Minutes
|
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Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 60 Minutes
Időkeret: 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
Időkeret: 75 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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75 Minutes
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Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 90 Minutes
Időkeret: 90 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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90 Minutes
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Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 120 Minutes
Időkeret: 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
Időkeret: 180 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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180 Minutes
|
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Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 240 Minutes
Időkeret: 240 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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240 Minutes
|
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Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 300 Minutes
Időkeret: 300 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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300 Minutes
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Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 360 Minutes
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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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Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Nyomozók
- Tanulmányi igazgató: Daniel Qi, M.D., McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
Publikációk és hasznos linkek
A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete
2010. június 1.
Elsődleges befejezés (Tényleges)
2011. január 1.
A tanulmány befejezése (Tényleges)
2011. január 1.
Tanulmányi regisztráció dátumai
Először benyújtva
2010. április 30.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2010. május 3.
Első közzététel (Becslés)
2010. május 4.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Becslés)
2012. május 28.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2012. április 26.
Utolsó ellenőrzés
2012. április 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- ACEPAI2001
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .
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