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Study of Acetaminophen (ACM) in Post-operative Dental Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02735122
Recruitment Status : Completed
First Posted : April 12, 2016
Last Update Posted : December 18, 2017
Sponsor:
Collaborator:
Johnson & Johnson Consumer and Personal Products Worldwide
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division )

Tracking Information
First Submitted Date  ICMJE March 31, 2016
First Posted Date  ICMJE April 12, 2016
Last Update Posted Date December 18, 2017
Actual Study Start Date  ICMJE April 30, 2016
Actual Primary Completion Date October 5, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 6, 2016)
Time to first confirmed perceptible pain relief [ Time Frame: 6 hours ]
Minutes until confirmed first perceptible pain relief are achieved. Stopwatch is started after the subject takes the study medication. The subject is instructed to stop the stopwatch when they first begin to feel any pain relief. The first perceptible pain relief is confirmed if the subject also stopped the second stopwatch indicating meaningful pain relief.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02735122 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2016)
  • Percentage of subjects with confirmed perceptible relief from 30 minutes to successively earlier minutes in one-minute increments (Test ACM versus placebo) [ Time Frame: 30 minutes or less ]
  • Risk ratios of confirmed perceptible relief by 10 minutes (Test acetominophen and commercial ibuprofen) [ Time Frame: 10 minutes or less ]
    The risk ratios and confidence intervals for incidence of confirmed perceptible relief of Test ACM divided by commercial IBU will be presented for 10 minutes
  • Risk ratios of confirmed perceptible relief by 15 minutes (Test acetominophen and commercial ibuprofen) [ Time Frame: 15 minutes or less ]
    The risk ratios and confidence intervals for incidence of confirmed perceptible relief of Test ACM divided by commercial IBU will be presented for 15 minutes
  • Risk ratios of confirmed perceptible relief by 20 minutes (Test acetominophen and commercial ibuprofen) [ Time Frame: 20 minutes or less ]
    The risk ratios and confidence intervals for incidence of confirmed perceptible relief of Test ACM divided by commercial IBU will be presented for 20 minutes
  • Percentage of subjects with meaningful relief by 30 minutes [ Time Frame: 30 minutes or less ]
  • Time to meaningful pain relief [ Time Frame: 6 hours ]
    Minutes until meaningful pain relief are achieved. Stopwatch is started after the subject takes the study medication. The subjects are instructed to stop the stopwatch when the relief from the starting pain is meaningful to them.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Acetaminophen (ACM) in Post-operative Dental Pain
Official Title  ICMJE A Randomized, Double-Blind, Placebo- and Active- Controlled, Single-Dose, Efficacy, Safety, and Pharmacokinetics Study of a Test Acetaminophen 500 mg Tablet in Postoperative Dental Pain
Brief Summary This is a Dental Pain Study which will evaluate the analgesic onset, efficacy and safety of 1000 mg acetaminophen as two Test acetaminophen 500 mg tablets, compared with commercial products of acetaminophen 1000 mg administered as two 500 mg caplets, and ibuprofen (IBU) 400 mg following third molar (wisdom tooth) extraction.
Detailed Description This is a single-dose, randomized, double-blind, triple-dummy, placebo- and active controlled, parallel-group study to evaluate the analgesic onset, efficacy, and safety profile of Test acetaminophen 1000 mg compared with two commercial products over a six-hour period after third-molar extractions. Subjects will undergo dental extraction of three or four third molars.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Post Operative Dental Pain
Intervention  ICMJE
  • Drug: acetaminophen Tablet
    2 test acetaminophen 500 mg tablets
    Other Name: Test ACM
  • Drug: acetaminophen Caplet
    2 commercial acetaminophen 500 mg caplets
    Other Name: Commercial ACM
  • Drug: ibuprofen Liquid-filled capsule
    2 commercial ibuprofen 200 mg Liquid-filled capsules
    Other Name: Commercial IBU
  • Drug: Placebo Tablet
    2 placebo tablets
  • Drug: Placebo Caplet
    2 placebo caplets
  • Drug: Placebo Liquid-filled capsule
    2 placebo Liquid-filled capsules
Study Arms  ICMJE
  • Experimental: Test acetaminophen
    acetaminophen tablet and placebo caplet and placebo liquid-filled capsule
    Interventions:
    • Drug: acetaminophen Tablet
    • Drug: Placebo Caplet
    • Drug: Placebo Liquid-filled capsule
  • Active Comparator: Commercial acetaminophen
    acetaminophen caplet and placebo tablet and placebo liquid-filled capsule
    Interventions:
    • Drug: acetaminophen Caplet
    • Drug: Placebo Tablet
    • Drug: Placebo Liquid-filled capsule
  • Active Comparator: Commercial ibuprofen
    ibuprofen liquid-filled capsule and placebo tablet and placebo caplet
    Interventions:
    • Drug: ibuprofen Liquid-filled capsule
    • Drug: Placebo Tablet
    • Drug: Placebo Caplet
  • Placebo Comparator: Placebo
    Placebo tablet and placebo caplet and placebo liquid-filled capsule
    Interventions:
    • Drug: Placebo Tablet
    • Drug: Placebo Caplet
    • Drug: Placebo Liquid-filled capsule
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 6, 2016)
420
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 5, 2016
Actual Primary Completion Date October 5, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 17 years to 50 years old
  2. Weight 100 lbs or greater with a body mass index (BMI) 18-30 inclusive
  3. Dental extraction of three or four molars
  4. Experience moderate to severe pain after extraction of third molars
  5. Females of childbearing age must be willing to use acceptable method of birth control

Exclusion Criteria:

  1. Currently pregnant or planning to be pregnant or nursing a baby
  2. Known allergy to acetaminophen (ACM) or non-steroidal anti-inflammatory drugs (NSAIDS)
  3. Inability to swallow whole large tablets or capsules
  4. Have other conditions that the investigator feels may impact subject's safety and/or the integrity of the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 17 Years to 50 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02735122
Other Study ID Numbers  ICMJE CO-151027203834-PACT
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: At this time we do plan to share IPD through the YODA site. The specific individual participant data sets have not yet been determined.
Responsible Party Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division )
Study Sponsor  ICMJE Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Collaborators  ICMJE Johnson & Johnson Consumer and Personal Products Worldwide
Investigators  ICMJE
Principal Investigator: Derek D. Muse, M.D. Jean Brown Research
PRS Account Johnson & Johnson Consumer and Personal Products Worldwide
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP