Dental PainPhase 2NCT01960114

Study of Long-Acting Acetaminophen in Postoperative Dental Pain

A Phase 2 study testing Acetaminophen ER in people with Dental Pain, run by McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 17 to 45 years
Conditions the study is for: Dental Pain
What is being tested?: Acetaminophen ER
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 403 participants
Where: 1 siteUnited States
Study dates: Oct 2013to Apr 2014
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 17 to 45 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Jean Brown Research
Salt Lake City, Utah, 84124

Other trials in United States

About this study

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

Conditions: Dental Pain
Being tested: Acetaminophen ER, Placebo
Keywords: Acetaminophen, Paracetamol Analgesics, Analgesics, Non-Narcotic Pain, Postoperative Pain, Antipyretics Dental Surgery, Third molar extraction
Medical subject headings: Toothache, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01960114
Study group	Role	What they receive
Acetaminophen ER	Experimental	Not described Receives: Drug: Acetaminophen ER
Placebo	Placebo comparator	Single dose (2 tablets) Acetaminophen ER 750 mg matching placebo Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 10 Hours

Secondary outcomes (4)

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.
Measured: Within 12 Hours
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.
Measured: Within 12 Hours
Duration of Pain Relief
Minutes until rescue medication was given.
Measured: Within 12 Hours
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.
Measured: 12 Hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2013Apr 2014

First posted10 Oct 2013 (estimated)
Study startOct 2013
Primary completionApr 2014
Study completionApr 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Dental PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 403 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01960114
Sponsor's protocol ID: AERPAI2001
Status last verified: Jun 2015
First submitted: 8 Oct 2013
Last updated: 10 Jul 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
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PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
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Submucosal Cryotherapy and Anti-inflammatory Drugs for Postoperative Pain Following Root Canal Treatment in Maxillary Molars
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All Dental Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01960114
Acronym / sponsor ID: AERPAI2001
Conditions: Dental Pain
Keywords: Acetaminophen, Paracetamol Analgesics, Analgesics, Non-Narcotic Pain, Postoperative Pain, Antipyretics Dental Surgery, Third molar extraction
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 403 participants (actual)
Lead sponsor: McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.Industry (pharma, biotech, devices)
Study start: Oct 2013
Primary completion: Apr 2014 (actual)
Study completion: Apr 2014 (actual)
First posted: 10 Oct 2013 (estimated)
Results: Posted 10 Jun 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Acetaminophen ER	Experimental	Drug: Acetaminophen ER
Placebo	Placebo comparator	Drug: PlaceboSingle dose (2 tablets) Acetaminophen ER 750 mg matching placebo

Who may qualify

Ages: 17 to 45 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Acetaminophen ERSingle dose (2 tablets) Acetaminophen ER 750 mg	Drug	Acetaminophen ER
PlaceboSingle dose (2 tablets) Acetaminophen ER 750 mg matching placebo	Drug	Placebo

Primary outcome

Time Weighted Sum of Pain Intensity Difference (PID) Over 10 Hours (SPID 0-10)
Time frame: 10 Hours
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.

4 secondary outcomes

Time to Confirmed First Perceptible Pain Relief
Time frame: Within 12 Hours
Time to Meaningful Pain Relief
Time frame: Within 12 Hours
Duration of Pain Relief
Time frame: Within 12 Hours
Patient Global Evaluation
Time frame: 12 Hours

Results and safety

Results posted to the registry on 10 Jun 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	134	133
ACE ER 1500 mg	269	268

Primary outcome: Time Weighted Sum of Pain Intensity Difference (PID) Over 10 Hours (SPID 0-10)

Time frame: 10 Hours. Least squares mean (Standard Error). Unit: units on a scale

Measure	Placebo n = 134	ACE ER 1500 mg n = 269
Value	5.745 (2.5056)	30.986 (1.8951)

Placebo vs ACE ER 1500 mg: Least Squares Mean Difference: 25.241 (95% CI 19.669 to 30.813), p <0.001, ANOVA

Population analysed: Analysis was based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 5-7 for non-serious adverse events, until 30 days after the last study site visit for serious adverse events.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 134 (0%)	14 of 134 (10.4%)	Not reported
ACE ER 1500 mg	0 of 268 (0%)	26 of 268 (9.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Dental Pain

Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
Not yet recruiting
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis
Not yet recruitingPhase 3
Submucosal Cryotherapy and Anti-inflammatory Drugs for Postoperative Pain Following Root Canal Treatment in Maxillary Molars
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

McNeil Study Director study director

McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Acetaminophen ER in people with Dental Pain, run by McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time Weighted Sum of Pain Intensity Difference (PID) Over 10 Hours (SPID 0-10) (time frame: 10 Hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01960114.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2015.