NCT01960114

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
403

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2013

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

Study Start

First participant enrolled

October 1, 2013

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 8, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 10, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

June 10, 2015

Completed
Last Updated

July 10, 2015

Status Verified

June 1, 2015

Enrollment Period

6 months

First QC Date

October 8, 2013

Results QC Date

May 28, 2015

Last Update Submit

June 11, 2015

Conditions

Dental Pain

Keywords

AcetaminophenParacetamol AnalgesicsAnalgesicsNon-Narcotic PainPostoperative PainAntipyretics Dental SurgeryThird molar extraction

Outcome Measures

Primary Outcomes (1)

  • 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.

    10 Hours

Secondary Outcomes (4)

  • Time to Confirmed First Perceptible Pain Relief

    Within 12 Hours

  • Time to Meaningful Pain Relief

    Within 12 Hours

  • Duration of Pain Relief

    Within 12 Hours

  • Patient Global Evaluation

    12 Hours

Study Arms (2)

Acetaminophen ER

EXPERIMENTAL
Drug: Acetaminophen ER

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Acetaminophen ERDRUG

Single dose (2 tablets) Acetaminophen ER 750 mg

Acetaminophen ER
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age17 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

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, Postoperative

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesFacial PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Results Point of Contact

Title
Rajesh Mishra, MD, PhD/Vice President, Medical/Clinical Affairs, Global OTC
Organization
McNeil Consumer Healthcare
rmishr16@its.jnj.com
215-273-8569 USA EST

Study Officials

  • McNeil Study Director

    McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

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

October 8, 2013

First Posted

October 10, 2013

Study Start

October 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

July 10, 2015

Results First Posted

June 10, 2015

Record last verified: 2015-06

Locations

US(1)