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Study of Long-Acting Acetaminophen in Postoperative Dental Pain

Primary Purpose

Dental Pain

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Acetaminophen ER
Placebo
Sponsored by
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Pain focused on measuring Acetaminophen, Paracetamol Analgesics, Analgesics, Non-Narcotic Pain, Postoperative Pain, Antipyretics Dental Surgery, Third molar extraction

Eligibility Criteria

17 Years - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Must be at least 17 and less than 46 years of age
  • Must weigh at least 100 lbs with a body mass index of at least 18 and less than 30
  • Scheduled to undergo surgical extraction of one impacted third molar from the lower jaw. The third molar from the upper jaw from the same side may also be removed.
  • Experiencing moderate to severe pain after extraction of third molars.

Exclusion Criteria:

  • Cannot be allergic to acetaminophen (Tylenol) or any non-steroidal anti-inflammatory drugs (e.g., Motrin, Advil, Aleve, Naproxen).
  • Cannot be pregnant (or planning to be pregnant) or nursing a baby
  • Unable to swallow whole large tablets or caplets.
  • Cannot have any other medical conditions that the investigator feels may compromise your safety or the study results.

Sites / Locations

  • Jean Brown Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Acetaminophen ER

Placebo

Arm Description

Single dose (2 tablets) Acetaminophen ER 750 mg matching placebo

Outcomes

Primary Outcome Measures

Time Weighted Sum of Pain Intensity Difference (PID) Over 10 Hours (SPID 0-10)
Time weighted sum of pain intensity difference scores from baseline over 10 hours. Pain intensity was evaluated using a 0-10 numerical rating scale (NRS) where 0 = no pain and 10 = very severe pain. SPID 0-10 = 0.25 x (PID at 15 min + PID at 30 min + PID at 45 min + PID at 60 min + PID at 75 min + PID at 90 min) + 0.5 x (PID at 120 min) + PID at 3 h + PID at 4 h + PID at 5 h + PID at 6 h + PID at 7 h + PID at 8 h + PID at 9 h + PID at 10 h.

Secondary Outcome Measures

Time to Confirmed First Perceptible Pain Relief
Minutes until confirmed first perceptible pain relief was achieved. Stopwatch was started after the subject took the study medication. The subject was instructed to stop the stopwatch when they first began to feel any pain relief. The first perceptible pain relief was confirmed if the subject also stopped the second stopwatch indicating meaningful pain relief.
Time to Meaningful Pain Relief
Minutes until meaningful pain relief was achieved. Stopwatch was started after the subject took the study medication. The subjects were instructed to stop the stopwatch when the relief from the starting pain was meaningful to them.
Duration of Pain Relief
Minutes until rescue medication was given.
Patient Global Evaluation
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.

Full Information

First Posted
October 8, 2013
Last Updated
June 11, 2015
Sponsor
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01960114
Brief Title
Study of Long-Acting Acetaminophen in Postoperative Dental Pain
Official Title
A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Efficacy, Safety, and Pharmacokinetics Study of Extended-Release (ER) Acetaminophen in Postoperative Dental Pain
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to evaluate the efficacy and safety of acetaminophen ER 1500 mg (two 750 mg tablets) over 10 to 12 hours in the dental pain model following third molar extraction(s) and to evaluate the pharmacokinetics of acetaminophen ER 1500 mg (two 750 mg tablets) in a sub-group of subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Pain
Keywords
Acetaminophen, Paracetamol Analgesics, Analgesics, Non-Narcotic Pain, Postoperative Pain, Antipyretics Dental Surgery, Third molar extraction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
403 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acetaminophen ER
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Single dose (2 tablets) Acetaminophen ER 750 mg matching placebo
Intervention Type
Drug
Intervention Name(s)
Acetaminophen ER
Intervention Description
Single dose (2 tablets) Acetaminophen ER 750 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Single dose (2 tablets) Acetaminophen ER 750 mg matching placebo
Primary Outcome Measure Information:
Title
Time Weighted Sum of Pain Intensity Difference (PID) Over 10 Hours (SPID 0-10)
Description
Time weighted sum of pain intensity difference scores from baseline over 10 hours. Pain intensity was evaluated using a 0-10 numerical rating scale (NRS) where 0 = no pain and 10 = very severe pain. SPID 0-10 = 0.25 x (PID at 15 min + PID at 30 min + PID at 45 min + PID at 60 min + PID at 75 min + PID at 90 min) + 0.5 x (PID at 120 min) + PID at 3 h + PID at 4 h + PID at 5 h + PID at 6 h + PID at 7 h + PID at 8 h + PID at 9 h + PID at 10 h.
Time Frame
10 Hours
Secondary Outcome Measure Information:
Title
Time to Confirmed First Perceptible Pain Relief
Description
Minutes until confirmed first perceptible pain relief was achieved. Stopwatch was started after the subject took the study medication. The subject was instructed to stop the stopwatch when they first began to feel any pain relief. The first perceptible pain relief was confirmed if the subject also stopped the second stopwatch indicating meaningful pain relief.
Time Frame
Within 12 Hours
Title
Time to Meaningful Pain Relief
Description
Minutes until meaningful pain relief was achieved. Stopwatch was started after the subject took the study medication. The subjects were instructed to stop the stopwatch when the relief from the starting pain was meaningful to them.
Time Frame
Within 12 Hours
Title
Duration of Pain Relief
Description
Minutes until rescue medication was given.
Time Frame
Within 12 Hours
Title
Patient Global Evaluation
Description
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.
Time Frame
12 Hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Must be at least 17 and less than 46 years of age Must weigh at least 100 lbs with a body mass index of at least 18 and less than 30 Scheduled to undergo surgical extraction of one impacted third molar from the lower jaw. The third molar from the upper jaw from the same side may also be removed. Experiencing moderate to severe pain after extraction of third molars. Exclusion Criteria: Cannot be allergic to acetaminophen (Tylenol) or any non-steroidal anti-inflammatory drugs (e.g., Motrin, Advil, Aleve, Naproxen). Cannot be pregnant (or planning to be pregnant) or nursing a baby Unable to swallow whole large tablets or caplets. Cannot have any other medical conditions that the investigator feels may compromise your safety or the study results.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
McNeil Study Director
Organizational Affiliation
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Jean Brown Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States

12. IPD Sharing Statement

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Study of Long-Acting Acetaminophen in Postoperative Dental Pain

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