- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01115673
To Evaluate the Safety and Efficacy of Acetaminophen 650 mg and 1000mg in Dental Pain After Surgery
26 april 2012 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
540
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Utah
-
Salt Lake City, Utah, Förenta staterna, 84124
- Jean Brown Research
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
16 år till 50 år (Barn, Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: ACE-1000
1000 mg Acetaminophen Caplet
|
Acetaminophen Caplet - single dose
Andra namn:
|
Aktiv komparator: ACE-650
650 mg Acetaminophen Caplet
|
Acetaminophen Caplet - single dose
Andra namn:
|
Placebo-jämförare: ACE-0
0 mg Acetaminophen Caplet
|
0 mg Caplet - single dose
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Overall Analgesic Efficacy - Sum of Pain Intensity Difference and Pain Relief Scores Over Six Hours (SPRID6)
Tidsram: 6 Hours
|
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.
|
6 Hours
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Sum of Pain Intensity Difference Over Six Hours (SPID6)
Tidsram: 6 Hours
|
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.
|
6 Hours
|
Sum of Pain Relief Scores Over Six Hours (TOTPAR6)
Tidsram: 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.
|
6 Hours
|
Pain Intensity Difference (PID) at 15 Minutes
Tidsram: 15 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.
|
15 Minutes
|
Pain Intensity Difference (PID) at 30 Minutes
Tidsram: 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.
|
30 Minutes
|
Pain Intensity Difference (PID) at 45 Minutes
Tidsram: 45 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.
|
45 Minutes
|
Pain Intensity Difference (PID) at 60 Minutes
Tidsram: 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.
|
60 Minutes
|
Pain Intensity Difference (PID) at 75 Minutes
Tidsram: 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
|
Pain Intensity Difference (PID) at 90 Minutes
Tidsram: 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.
|
90 Minutes
|
Pain Intensity Difference (PID) at 120 Minutes
Tidsram: 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.
|
120 Minutes
|
Pain Intensity Difference (PID) at 180 Minutes
Tidsram: 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.
|
180 Minutes
|
Pain Intensity Difference (PID) at 240 Minutes
Tidsram: 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.
|
240 Minutes
|
Pain Intensity Difference (PID) at 300 Minutes
Tidsram: 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
|
Pain Intensity Difference (PID) at 360 Minutes
Tidsram: 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.
|
360 Minutes
|
Pain Relief (PAR) Scores at 15 Minutes
Tidsram: 15 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
|
15 Minutes
|
Pain Relief (PAR) Scores at 30 Minutes
Tidsram: 30 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
|
30 Minutes
|
Pain Relief (PAR) Scores at 45 Minutes
Tidsram: 45 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
|
45 Minutes
|
Pain Relief (PAR) Scores at 60 Minutes
Tidsram: 60 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
|
60 Minutes
|
Pain Relief (PAR) Scores at 75 Minutes
Tidsram: 75 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
|
75 Minutes
|
Pain Relief (PAR) Scores at 90 Minutes
Tidsram: 90 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
|
90 Minutes
|
Pain Relief (PAR) Scores at 120 Minutes
Tidsram: 120 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
|
120 Minutes
|
Pain Relief (PAR) Scores at 180 Minutes
Tidsram: 180 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
|
180 Minutes
|
Pain Relief (PAR) Scores at 240 Minutes
Tidsram: 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
|
240 Minutes
|
Pain Relief (PAR) Scores at 300 Minutes
Tidsram: 300 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
|
300 Minutes
|
Pain Relief (PAR) Scores at 360 Minutes
Tidsram: 360 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
|
360 Minutes
|
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 15 Minutes
Tidsram: 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
|
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 30 Minutes
Tidsram: 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
Tidsram: 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
|
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 60 Minutes
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Time to Meaningful Pain Relief
Tidsram: 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.
|
within 6 Hours
|
Time to Confirmed Perceptible Pain Relief
Tidsram: 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.
|
within 6 Hours
|
Duration of Analgesia - Time to Rescue
Tidsram: within 6 Hours
|
Minutes until rescue medication was given.
|
within 6 Hours
|
Rescue Rates Through Four Hours
Tidsram: through 4 Hours
|
Percentage of subjects using rescue medication.
|
through 4 Hours
|
Rescue Rates Through Six Hours
Tidsram: through 6 Hours
|
Percentage of subjects using rescue medication.
|
through 6 Hours
|
Percentage of Subjects With >50% of the Maximum Possible TOTPAR6 Score
Tidsram: 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
|
6 Hours
|
Patient Global Evaluation
Tidsram: 6 Hours
|
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
|
6 Hours
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Studierektor: Daniel Qi, M.D., McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juni 2010
Primärt slutförande (Faktisk)
1 januari 2011
Avslutad studie (Faktisk)
1 januari 2011
Studieregistreringsdatum
Först inskickad
30 april 2010
Först inskickad som uppfyllde QC-kriterierna
3 maj 2010
Första postat (Uppskatta)
4 maj 2010
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
28 maj 2012
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
26 april 2012
Senast verifierad
1 april 2012
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ACEPAI2001
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