NCT01115673

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
540

participants targeted

Target at P75+ for phase_3 pain

Timeline
Completed

Started Jun 2010

Shorter than P25 for phase_3 pain

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

April 30, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 4, 2010

Completed
28 days until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

May 28, 2012

Completed
Last Updated

May 28, 2012

Status Verified

April 1, 2012

Enrollment Period

7 months

First QC Date

April 30, 2010

Results QC Date

January 4, 2012

Last Update Submit

April 26, 2012

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • Overall Analgesic Efficacy - Sum of Pain Intensity Difference and Pain Relief Scores Over Six Hours (SPRID6)

    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

Secondary Outcomes (42)

  • Sum of Pain Intensity Difference Over Six Hours (SPID6)

    6 Hours

  • Sum of Pain Relief Scores Over Six Hours (TOTPAR6)

    6 Hours

  • Pain Intensity Difference (PID) at 15 Minutes

    15 Minutes

  • Pain Intensity Difference (PID) at 30 Minutes

    30 Minutes

  • Pain Intensity Difference (PID) at 45 Minutes

    45 Minutes

  • +37 more secondary outcomes

Study Arms (3)

ACE-1000

EXPERIMENTAL

1000 mg Acetaminophen Caplet

Drug: Acetaminophen

ACE-650

ACTIVE COMPARATOR

650 mg Acetaminophen Caplet

Drug: Acetaminophen

ACE-0

PLACEBO COMPARATOR

0 mg Acetaminophen Caplet

Drug: Placebo Control

Interventions

AcetaminophenDRUG

Acetaminophen Caplet - single dose

Also known as: Tylenol
ACE-1000ACE-650
Placebo ControlDRUG

0 mg Caplet - single dose

Also known as: Control
ACE-0

Eligibility Criteria

Age16 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jean Brown Research

Salt Lake City, Utah, 84124, United States

Location

Related Publications (1)

  • Qi DS, May LG, Zimmerman B, Peng P, Atillasoy E, Brown JD, Cooper SA. A randomized, double-blind, placebo-controlled study of acetaminophen 1000 mg versus acetaminophen 650 mg for the treatment of postsurgical dental pain. Clin Ther. 2012 Dec;34(12):2247-2258.e3. doi: 10.1016/j.clinthera.2012.11.003. Epub 2012 Nov 28.

    PMID: 23200183DERIVED

MeSH Terms

Conditions

Pain

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Limitations and Caveats

Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.

Results Point of Contact

Title
Joyce Hauze, RPS Sr Specialist, Clinical Research Operations
Organization
Johnson & Johnson Consumer and Personal Products Worldwide
jhauze@its.jnj.com
928-277-0715

Study Officials

  • Daniel Qi, M.D.

    McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2010

First Posted

May 4, 2010

Study Start

June 1, 2010

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

May 28, 2012

Results First Posted

May 28, 2012

Record last verified: 2012-04

Locations

US(1)