PainPhase 3NCT01115673
To Evaluate the Safety and Efficacy of Acetaminophen 650 mg and 1000mg in Dental Pain After Surgery
A Phase 3 study testing Acetaminophen in people with Pain, run by McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. at 1 site in United States.
Trial summary
The objective of this study is to evaluate the safety and efficacy of acetaminophen 650 mg and acetaminophen 1000 mg in dental surgery. Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- Pain
- What is being tested?
- Acetaminophen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 540 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Jan 2011
- Phase
- Phase 3
- 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 16 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Safety and Efficacy Study of Acetaminophen 1000 mg and Acetaminophen 650 mg in Post Operative Dental Pain
The objective of this study is to evaluate the safety and efficacy of acetaminophen 650 mg and acetaminophen 1000 mg in dental surgery.
Read the detailed description
This trial is to assess the relative efficacy of acetaminophen 1000 mg versus acetaminophen 650 mg over a six-hour period, in subjects experiencing at least moderate post-operative dental pain.
- Conditions
- Pain
- Being tested
- Acetaminophen, Placebo Control
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetaminophenDrug
Also called Tylenol
Acetaminophen Caplet - single dose
Placebo ControlDrug
Also called Control
0 mg Caplet - single dose
| Study group | Role | What they receive |
|---|---|---|
| ACE-1000 | Experimental | 1000 mg Acetaminophen Caplet Receives: Drug: Acetaminophen |
| ACE-650 | Active comparator | 650 mg Acetaminophen Caplet Receives: Drug: Acetaminophen |
| ACE-0 | Placebo comparator | 0 mg Acetaminophen Caplet Receives: Drug: Placebo Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 Hours
Secondary outcomes (42)
Sum of Pain Intensity Difference Over Six Hours (SPID6)
Weighted Sum of the Pain Intensity Difference from Baseline Over Six Hours (SPID6) - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain. The total possible minimum value is -300 (worst) and the total possible maximum value is 600 (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.
Measured: 6 Hours
Sum of Pain Relief Scores Over Six Hours (TOTPAR6)
Weighted Sum of the Pain Relief Scores Over Six Hours (TOTPAR6) - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief. The total possible minimum value is 0 (worst) and the total possible maximum value is 600 (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.
Measured: 6 Hours
Pain Intensity Difference (PID) at 15 Minutes
Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.
Measured: 15 Minutes
Pain Intensity Difference (PID) at 30 Minutes
Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.
Measured: 30 Minutes
Pain Intensity Difference (PID) at 45 Minutes
Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.
Measured: 45 Minutes
Pain Intensity Difference (PID) at 60 Minutes
Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.
Measured: 60 Minutes
Pain Intensity Difference (PID) at 75 Minutes
Pain Intensity Difference (PID) from Baseline at Each Assessment Time Point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.
Measured: 75 Minutes
Pain Intensity Difference (PID) at 90 Minutes
Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.
Measured: 90 Minutes
Pain Intensity Difference (PID) at 120 Minutes
Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.
Measured: 120 Minutes
Pain Intensity Difference (PID) at 180 Minutes
Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.
Measured: 180 Minutes
Pain Intensity Difference (PID) at 240 Minutes
Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.
Measured: 240 Minutes
Pain Intensity Difference (PID) at 300 Minutes
Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.
Measured: 300 Minutes
Pain Intensity Difference (PID) at 360 Minutes
Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.
Measured: 360 Minutes
Pain Relief (PAR) Scores at 15 Minutes
Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100
Measured: 15 Minutes
Pain Relief (PAR) Scores at 30 Minutes
Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100
Measured: 30 Minutes
Pain Relief (PAR) Scores at 45 Minutes
Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100
Measured: 45 Minutes
Pain Relief (PAR) Scores at 60 Minutes
Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100
Measured: 60 Minutes
Pain Relief (PAR) Scores at 75 Minutes
Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100
Measured: 75 Minutes
Pain Relief (PAR) Scores at 90 Minutes
Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100
Measured: 90 Minutes
Pain Relief (PAR) Scores at 120 Minutes
Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100
Measured: 120 Minutes
Pain Relief (PAR) Scores at 180 Minutes
Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100
Measured: 180 Minutes
Pain Relief (PAR) Scores at 240 Minutes
Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100
Measured: 240 Minutes
Pain Relief (PAR) Scores at 300 Minutes
Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100
Measured: 300 Minutes
Pain Relief (PAR) Scores at 360 Minutes
Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100
Measured: 360 Minutes
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 15 Minutes
Sum of PID and PAR Scores (PRID) at each Assessment Time point - 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
Measured: 15 Minutes
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 30 Minutes
Sum of PID and PAR Scores (PRID) at each Assessment Time point - 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
Measured: 30 Minutes
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 45 Minutes
Sum of PID and PAR Scores (PRID) at each Assessment Time point - 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
Measured: 45 Minutes
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 60 Minutes
Sum of PID and PAR Scores (PRID) at each Assessment Time point - 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
Measured: 60 Minutes
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 75 Minutes
Sum of PID and PAR Scores (PRID) at each Assessment Time point - 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
Measured: 75 Minutes
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 90 Minutes
Sum of PID and PAR Scores (PRID) at each Assessment Time point - 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
Measured: 90 Minutes
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 120 Minutes
Sum of PID and PAR Scores (PRID) at each Assessment Time point - 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
Measured: 120 Minutes
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 180 Minutes
Sum of PID and PAR Scores (PRID) at each Assessment Time point - 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
Measured: 180 Minutes
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 240 Minutes
Sum of PID and PAR Scores (PRID) at each Assessment Time point - 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
Measured: 240 Minutes
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 300 Minutes
Sum of PID and PAR Scores (PRID) at each Assessment Time point - 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
Measured: 300 Minutes
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 360 Minutes
Sum of PID and PAR Scores (PRID) at each Assessment Time point - 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
Measured: 360 Minutes
Time to Meaningful Pain Relief
Minutes until meaningful pain relief was achieved. A stopwatch was provided to the subject after ingestion of the study medication. The subject was instructed to stop the stopwatch when the relief from the starting pain was meaningful to them.
Measured: within 6 Hours
Time to Confirmed Perceptible Pain Relief
Minutes until confirmed perceptible pain relief was achieved. A stopwatch was provided to the subject after ingestion of the study medication. The subject was instructed to stop the stopwatch when they first began to feel any pain relieving effect whatsoever of the drug, that was when they first felt any pain relief. It did not necessarily mean they felt completely better, although they might have, but when they first felt any difference in the pain.
Measured: within 6 Hours
Duration of Analgesia - Time to Rescue
Minutes until rescue medication was given.
Measured: within 6 Hours
Rescue Rates Through Four Hours
Percentage of subjects using rescue medication.
Measured: through 4 Hours
Rescue Rates Through Six Hours
Percentage of subjects using rescue medication.
Measured: through 6 Hours
Percentage of Subjects With >50% of the Maximum Possible TOTPAR6 Score
Percentage of Subjects with >50% of the Maximum Possible TOTPAR6 Score - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 600 so >50% is >300 out of 600
Measured: 6 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: 6 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2010 (estimated)
- Study startJun 2010
- Primary completionJan 2011
- Study completionJan 2011
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 540 participants (actual)
Sponsor and investigators
- Lead sponsor
- McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Qi, M.D., Study director, McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01115673
- Sponsor's protocol ID
- ACEPAI2001
- Status last verified
- Apr 2012
- First submitted
- 30 Apr 2010
- Last updated
- 28 May 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 23200183
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2012. 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, Safety and Efficacy Study of Acetaminophen 1000 mg and Acetaminophen 650 mg in Post Operative Dental Pain
- ClinicalTrials.gov ID
- NCT01115673
- Acronym / sponsor ID
- ACEPAI2001
- Conditions
- Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 540 participants (actual)
- Lead sponsor
- McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 4 May 2010 (estimated)
- Results
- Posted 28 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the safety and efficacy of acetaminophen 650 mg and acetaminophen 1000 mg in dental surgery.
Detailed description
This trial is to assess the relative efficacy of acetaminophen 1000 mg versus acetaminophen 650 mg over a six-hour period, in subjects experiencing at least moderate post-operative dental pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ACE-1000 | Experimental | Drug: Acetaminophen1000 mg Acetaminophen Caplet |
| ACE-650 | Active comparator | Drug: Acetaminophen650 mg Acetaminophen Caplet |
| ACE-0 | Placebo comparator | Drug: Placebo Control0 mg Acetaminophen Caplet |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| AcetaminophenAlso: TylenolAcetaminophen Caplet - single dose | Drug | ACE-1000, ACE-650 |
| Placebo ControlAlso: Control0 mg Caplet - single dose | Drug | ACE-0 |
Primary outcome
Overall Analgesic Efficacy - Sum of Pain Intensity Difference and Pain Relief Scores Over Six Hours (SPRID6)
Time frame: 6 Hours
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.
42 secondary outcomes
Sum of Pain Intensity Difference Over Six Hours (SPID6)
Time frame: 6 Hours
Sum of Pain Relief Scores Over Six Hours (TOTPAR6)
Time frame: 6 Hours
Pain Intensity Difference (PID) at 15 Minutes
Time frame: 15 Minutes
Pain Intensity Difference (PID) at 30 Minutes
Time frame: 30 Minutes
Pain Intensity Difference (PID) at 45 Minutes
Time frame: 45 Minutes
Pain Intensity Difference (PID) at 60 Minutes
Time frame: 60 Minutes
Pain Intensity Difference (PID) at 75 Minutes
Time frame: 75 Minutes
Pain Intensity Difference (PID) at 90 Minutes
Time frame: 90 Minutes
Pain Intensity Difference (PID) at 120 Minutes
Time frame: 120 Minutes
Pain Intensity Difference (PID) at 180 Minutes
Time frame: 180 Minutes
Pain Intensity Difference (PID) at 240 Minutes
Time frame: 240 Minutes
Pain Intensity Difference (PID) at 300 Minutes
Time frame: 300 Minutes
Pain Intensity Difference (PID) at 360 Minutes
Time frame: 360 Minutes
Pain Relief (PAR) Scores at 15 Minutes
Time frame: 15 Minutes
Pain Relief (PAR) Scores at 30 Minutes
Time frame: 30 Minutes
Pain Relief (PAR) Scores at 45 Minutes
Time frame: 45 Minutes
Pain Relief (PAR) Scores at 60 Minutes
Time frame: 60 Minutes
Pain Relief (PAR) Scores at 75 Minutes
Time frame: 75 Minutes
Pain Relief (PAR) Scores at 90 Minutes
Time frame: 90 Minutes
Pain Relief (PAR) Scores at 120 Minutes
Time frame: 120 Minutes
Pain Relief (PAR) Scores at 180 Minutes
Time frame: 180 Minutes
Pain Relief (PAR) Scores at 240 Minutes
Time frame: 240 Minutes
Pain Relief (PAR) Scores at 300 Minutes
Time frame: 300 Minutes
Pain Relief (PAR) Scores at 360 Minutes
Time frame: 360 Minutes
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 15 Minutes
Time frame: 15 Minutes
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 30 Minutes
Time frame: 30 Minutes
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 45 Minutes
Time frame: 45 Minutes
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 60 Minutes
Time frame: 60 Minutes
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 75 Minutes
Time frame: 75 Minutes
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 90 Minutes
Time frame: 90 Minutes
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 120 Minutes
Time frame: 120 Minutes
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 180 Minutes
Time frame: 180 Minutes
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 240 Minutes
Time frame: 240 Minutes
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 300 Minutes
Time frame: 300 Minutes
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 360 Minutes
Time frame: 360 Minutes
Time to Meaningful Pain Relief
Time frame: within 6 Hours
Time to Confirmed Perceptible Pain Relief
Time frame: within 6 Hours
Duration of Analgesia - Time to Rescue
Time frame: within 6 Hours
Rescue Rates Through Four Hours
Time frame: through 4 Hours
Rescue Rates Through Six Hours
Time frame: through 6 Hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23200183Qi 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.
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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.
Daniel Qi, M.D. 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 3 study testing Acetaminophen in people with 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 3 inclusion and 3 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 28 May 2012. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 28 May 2012). 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?
Overall Analgesic Efficacy - Sum of Pain Intensity Difference and Pain Relief Scores Over Six Hours (SPRID6) (time frame: 6 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 NCT01115673, which also lists 1 linked publication.
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 28 May 2012.