NCT02320708

Brief Summary

This is a dental pain study evaluating the efficacy and safety of a single dose of test acetaminophen (ACE) (1000 mg) compared to commercial acetaminophen (1000 mg), ibuprofen (IBU) (400 mg), and placebo over a 6 hour period. Subjects will undergo dental extraction of three or four third molars.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 19, 2014

Completed
12 days until next milestone

Study Start

First participant enrolled

December 31, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2015

Completed
Last Updated

December 3, 2021

Status Verified

November 1, 2021

Enrollment Period

4 months

First QC Date

December 16, 2014

Last Update Submit

November 29, 2021

Conditions

Dental Pain

Keywords

Molar,third; Teeth,wisdom; Pain, Postoperative; Dental Surgery; Third molar extraction

Outcome Measures

Primary Outcomes (1)

  • Time weighted sum of pain intensity difference from 0-6 hours (SPID 0-6)

    Time weighted sum of pain intensity difference scores from baseline over 6 hours. Pain intensity was evaluated using a 0-10 pain intensity numerical rating scale (PI-NRS) where 0 = no pain and 10 = very severe pain

    6 Hours

Secondary Outcomes (31)

  • Time weighted sum of pain intensity difference from 0-4 hours (SPID 0-4)

    4 Hours

  • Time to meaningful pain relief

    Within 6 Hours

  • Time to first perceptible pain relief

    Within 6 Hours

  • Time to confirmed first perceptible relief

    Within 6 Hours

  • Time weighted sum of pain relief from 0-4 (TOTPAR 0-4)

    4 hours

  • +26 more secondary outcomes

Study Arms (4)

Test Acetaminophen (ACE) (1000 mg) and placebo

EXPERIMENTAL
Drug: Acetaminophen (ACE) (1000 mg)Drug: Placebo

Commerical ACE (1000 mg) and placebo

ACTIVE COMPARATOR
Drug: Commercial ACE (1000 mg)Drug: Placebo

Commerical Ibuprofen (IBU) (400 mg) and placebo

ACTIVE COMPARATOR
Drug: Commercial Ibuprofen (IBU) (400 mg)Drug: Placebo

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Acetaminophen (ACE) (1000 mg)DRUG

2 Test ACE 500 mg tablets taken orally one time

Test Acetaminophen (ACE) (1000 mg) and placebo
Commercial ACE (1000 mg)DRUG

2 ACE 500 mg caplets taken orally one time

Commerical ACE (1000 mg) and placebo
Commercial Ibuprofen (IBU) (400 mg)DRUG

2 IBU 200 mg soft-gels taken orally one time

Commerical Ibuprofen (IBU) (400 mg) and placebo
PlaceboDRUG

2 placebo caplets for acetaminophen taken orally one time

Commerical Ibuprofen (IBU) (400 mg) and placeboPlaceboTest Acetaminophen (ACE) (1000 mg) and placebo

Eligibility Criteria

Age17 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Are 17 to 50 years of age
  • Weigh 100 lbs or greater and body mass index (BMI) 18 to 30 (inclusive)
  • Dental extraction of three or four third-molars.
  • Experience moderate to severe pain after extraction of third molars

You may not qualify if:

  • Currently pregnant (or planning to be pregnant) or nursing a baby
  • Known allergy to acetaminophen (ACE) or non-steroidal anti-inflammatory drugs (NSAIDs)
  • Inability to swallow whole large tablets or capsules
  • Have other conditions that the investigator feels may impact subject's safety and/or the integrity of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jean Brown Research

Salt Lake City, Utah, 84124, United States

Location

MeSH Terms

Conditions

ToothachePain

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesFacial PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Study Director

    McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2014

First Posted

December 19, 2014

Study Start

December 31, 2014

Primary Completion

April 30, 2015

Study Completion

April 30, 2015

Last Updated

December 3, 2021

Record last verified: 2021-11

Locations

US(1)