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To Evaluate the Safety and Efficacy of Acetaminophen 650 mg and 1000mg in Dental Pain After Surgery

torstai 26. huhtikuuta 2012 päivittänyt: 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.

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Interventio / Hoito

Yksityiskohtainen kuvaus

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.

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

540

Vaihe

  • Vaihe 3

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

  • Yhdysvallat
    • Utah
      • Salt Lake City, Utah, Yhdysvallat, 84124
        • Jean Brown Research

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

16 vuotta - 50 vuotta (Lapsi, Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

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

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Kaksinkertainen

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: ACE-1000
1000 mg Acetaminophen Caplet
Lääke: Acetaminophen
Acetaminophen Caplet - single dose
Muut nimet:
  • Tylenol
Active Comparator: ACE-650
650 mg Acetaminophen Caplet
Lääke: Acetaminophen
Acetaminophen Caplet - single dose
Muut nimet:
  • Tylenol
Placebo Comparator: ACE-0
0 mg Acetaminophen Caplet
Lääke: Placebo Control
0 mg Caplet - single dose
Muut nimet:
  • Ohjaus

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Overall Analgesic Efficacy - Sum of Pain Intensity Difference and Pain Relief Scores Over Six Hours (SPRID6)
Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Sum of Pain Intensity Difference Over Six Hours (SPID6)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: within 6 Hours
Minutes until rescue medication was given.
within 6 Hours
Rescue Rates Through Four Hours
Aikaikkuna: through 4 Hours
Percentage of subjects using rescue medication.
through 4 Hours
Rescue Rates Through Six Hours
Aikaikkuna: through 6 Hours
Percentage of subjects using rescue medication.
through 6 Hours
Percentage of Subjects With >50% of the Maximum Possible TOTPAR6 Score
Aikaikkuna: 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
Aikaikkuna: 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

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.

Tutkijat

  • Opintojohtaja: Daniel Qi, M.D., McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.

Julkaisuja ja hyödyllisiä linkkejä

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Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus

Tiistai 1. kesäkuuta 2010

Ensisijainen valmistuminen (Todellinen)

Lauantai 1. tammikuuta 2011

Opintojen valmistuminen (Todellinen)

Lauantai 1. tammikuuta 2011

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Perjantai 30. huhtikuuta 2010

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Maanantai 3. toukokuuta 2010

Ensimmäinen Lähetetty (Arvio)

Tiistai 4. toukokuuta 2010

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Arvio)

Maanantai 28. toukokuuta 2012

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Torstai 26. huhtikuuta 2012

Viimeksi vahvistettu

Sunnuntai 1. huhtikuuta 2012

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • ACEPAI2001

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