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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. )
ClinicalTrials.gov Identifier:
NCT01115673
First received: April 30, 2010
Last updated: April 26, 2012
Last verified: April 2012
  Purpose

The objective of this study is to evaluate the safety and efficacy of acetaminophen 650 mg and acetaminophen 1000 mg in dental surgery.


Condition Intervention Phase
Pain
Drug: Acetaminophen
Drug: Placebo Control
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Consumer and Personal Products Worldwide:

Primary Outcome Measures:
  • Overall Analgesic Efficacy - Sum of Pain Intensity Difference and Pain Relief Scores Over Six Hours (SPRID6) [ Time Frame: 6 Hours ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Sum of Pain Intensity Difference Over Six Hours (SPID6) [ Time Frame: 6 Hours ] [ Designated as safety issue: No ]
    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.

  • Sum of Pain Relief Scores Over Six Hours (TOTPAR6) [ Time Frame: 6 Hours ] [ Designated as safety issue: No ]
    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.

  • Pain Intensity Difference (PID) at 15 Minutes [ Time Frame: 15 Minutes ] [ Designated as safety issue: No ]
    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.

  • Pain Intensity Difference (PID) at 30 Minutes [ Time Frame: 30 Minutes ] [ Designated as safety issue: No ]
    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.

  • Pain Intensity Difference (PID) at 45 Minutes [ Time Frame: 45 Minutes ] [ Designated as safety issue: No ]
    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.

  • Pain Intensity Difference (PID) at 60 Minutes [ Time Frame: 60 Minutes ] [ Designated as safety issue: No ]
    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.

  • Pain Intensity Difference (PID) at 75 Minutes [ Time Frame: 75 Minutes ] [ Designated as safety issue: No ]
    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.

  • Pain Intensity Difference (PID) at 90 Minutes [ Time Frame: 90 Minutes ] [ Designated as safety issue: No ]
    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.

  • Pain Intensity Difference (PID) at 120 Minutes [ Time Frame: 120 Minutes ] [ Designated as safety issue: No ]
    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.

  • Pain Intensity Difference (PID) at 180 Minutes [ Time Frame: 180 Minutes ] [ Designated as safety issue: No ]
    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.

  • Pain Intensity Difference (PID) at 240 Minutes [ Time Frame: 240 Minutes ] [ Designated as safety issue: No ]
    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.

  • Pain Intensity Difference (PID) at 300 Minutes [ Time Frame: 300 Minutes ] [ Designated as safety issue: No ]
    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.

  • Pain Intensity Difference (PID) at 360 Minutes [ Time Frame: 360 Minutes ] [ Designated as safety issue: No ]
    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.

  • Pain Relief (PAR) Scores at 15 Minutes [ Time Frame: 15 Minutes ] [ Designated as safety issue: No ]
    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

  • Pain Relief (PAR) Scores at 30 Minutes [ Time Frame: 30 Minutes ] [ Designated as safety issue: No ]
    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

  • Pain Relief (PAR) Scores at 45 Minutes [ Time Frame: 45 Minutes ] [ Designated as safety issue: No ]
    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

  • Pain Relief (PAR) Scores at 60 Minutes [ Time Frame: 60 Minutes ] [ Designated as safety issue: No ]
    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

  • Pain Relief (PAR) Scores at 75 Minutes [ Time Frame: 75 Minutes ] [ Designated as safety issue: No ]
    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

  • Pain Relief (PAR) Scores at 90 Minutes [ Time Frame: 90 Minutes ] [ Designated as safety issue: No ]
    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

  • Pain Relief (PAR) Scores at 120 Minutes [ Time Frame: 120 Minutes ] [ Designated as safety issue: No ]
    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

  • Pain Relief (PAR) Scores at 180 Minutes [ Time Frame: 180 Minutes ] [ Designated as safety issue: No ]
    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

  • Pain Relief (PAR) Scores at 240 Minutes [ Time Frame: 240 Minutes ] [ Designated as safety issue: No ]
    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

  • Pain Relief (PAR) Scores at 300 Minutes [ Time Frame: 300 Minutes ] [ Designated as safety issue: No ]
    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

  • Pain Relief (PAR) Scores at 360 Minutes [ Time Frame: 360 Minutes ] [ Designated as safety issue: No ]
    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

  • Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 15 Minutes [ Time Frame: 15 Minutes ] [ Designated as safety issue: No ]
    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

  • Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 30 Minutes [ Time Frame: 30 Minutes ] [ Designated as safety issue: No ]
    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

  • Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 45 Minutes [ Time Frame: 45 Minutes ] [ Designated as safety issue: No ]
    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

  • Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 60 Minutes [ Time Frame: 60 Minutes ] [ Designated as safety issue: No ]
    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

  • Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 75 Minutes [ Time Frame: 75 Minutes ] [ Designated as safety issue: No ]
    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

  • Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 90 Minutes [ Time Frame: 90 Minutes ] [ Designated as safety issue: No ]
    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

  • Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 120 Minutes [ Time Frame: 120 Minutes ] [ Designated as safety issue: No ]
    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

  • Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 180 Minutes [ Time Frame: 180 Minutes ] [ Designated as safety issue: No ]
    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

  • Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 240 Minutes [ Time Frame: 240 Minutes ] [ Designated as safety issue: No ]
    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

  • Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 300 Minutes [ Time Frame: 300 Minutes ] [ Designated as safety issue: No ]
    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

  • Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 360 Minutes [ Time Frame: 360 Minutes ] [ Designated as safety issue: No ]
    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

  • Time to Meaningful Pain Relief [ Time Frame: within 6 Hours ] [ Designated as safety issue: No ]
    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.

  • Time to Confirmed Perceptible Pain Relief [ Time Frame: within 6 Hours ] [ Designated as safety issue: No ]
    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.

  • Duration of Analgesia - Time to Rescue [ Time Frame: within 6 Hours ] [ Designated as safety issue: No ]
    Minutes until rescue medication was given.

  • Rescue Rates Through Four Hours [ Time Frame: through 4 Hours ] [ Designated as safety issue: No ]
    Percentage of subjects using rescue medication.

  • Rescue Rates Through Six Hours [ Time Frame: through 6 Hours ] [ Designated as safety issue: No ]
    Percentage of subjects using rescue medication.

  • Percentage of Subjects With >50% of the Maximum Possible TOTPAR6 Score [ Time Frame: 6 Hours ] [ Designated as safety issue: No ]
    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

  • Patient Global Evaluation [ Time Frame: 6 Hours ] [ Designated as safety issue: No ]
    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


Enrollment: 540
Study Start Date: June 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ACE-1000
1000 mg Acetaminophen Caplet
Drug: Acetaminophen
Acetaminophen Caplet - single dose
Other Name: Tylenol
Active Comparator: ACE-650
650 mg Acetaminophen Caplet
Drug: Acetaminophen
Acetaminophen Caplet - single dose
Other Name: Tylenol
Placebo Comparator: ACE-0
0 mg Acetaminophen Caplet
Drug: Placebo Control
0 mg Caplet - single dose
Other Name: Control

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   16 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01115673

Locations
United States, Utah
Jean Brown Research
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
Investigators
Study Director: Daniel Qi, M.D. McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
  More Information

No publications provided by Johnson & Johnson Consumer and Personal Products Worldwide

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. )
ClinicalTrials.gov Identifier: NCT01115673     History of Changes
Other Study ID Numbers: ACEPAI2001
Study First Received: April 30, 2010
Results First Received: January 4, 2012
Last Updated: April 26, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Acetaminophen
Analgesics
Analgesics, Non-Narcotic
Antipyretics
Central Nervous System Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014