Trial · NCT01960114
Study of Long-Acting Acetaminophen in Postoperative Dental Pain
NCT01960114, Phase 2, Completed, McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.; results first posted 2015-06-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Long-Acting Acetaminophen in Postoperative Dental Pain. Trials, record NCT01960114. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01960114
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Long-Acting Acetaminophen in Postoperative Dental Pain
- NCT number
- NCT01960114
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 403 participants, actual
- Lead sponsor
- McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
- Conditions
- Dental Pain
- Interventions
- Acetaminophen ER, Placebo
- First posted
- 2013-10-10
- Last updated
- 2015-07-10
- Results first posted
- 2015-06-10
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time Weighted Sum of Pain Intensity Difference (PID) Over 10 Hours (SPID 0-10) | 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. |
| Secondary | Time to Confirmed First Perceptible Pain Relief | Within 12 Hours | 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. |
| Secondary | Time to Meaningful Pain Relief | Within 12 Hours | 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. |
| Secondary | Duration of Pain Relief | Within 12 Hours | Minutes until rescue medication was given. |
| Secondary | Patient Global Evaluation | 12 Hours | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time Weighted Sum of Pain Intensity Difference (PID) Over 10 Hours (SPID 0-10) | 10 Hours | Analysis was based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Time to Confirmed First Perceptible Pain Relief | Within 12 Hours | Analysis was based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized. | Minutes | MEDIAN |
| SECONDARY | Time to Meaningful Pain Relief | Within 12 Hours | Analysis was based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized. | Minutes | MEDIAN |
| SECONDARY | Duration of Pain Relief | Within 12 Hours | Analysis was based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized. | Minutes | MEDIAN |
| SECONDARY | Patient Global Evaluation | 12 Hours | Analysis was based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time Weighted Sum of Pain Intensity Difference (PID) Over 10 Hours (SPID 0-10) | Placebo | 5.745 | Standard Error 2.5056 | units on a scale | |
| Time Weighted Sum of Pain Intensity Difference (PID) Over 10 Hours (SPID 0-10) | ACE ER 1500 mg | 30.986 | Standard Error 1.8951 | units on a scale | |
| Time to Confirmed First Perceptible Pain Relief | Placebo | NA | 95% Confidence Interval NA to NA | Minutes | |
| Time to Confirmed First Perceptible Pain Relief | ACE ER 1500 mg | 26.817 | 95% Confidence Interval 23.683 to 29.950 | Minutes | |
| Time to Meaningful Pain Relief | Placebo | NA | 95% Confidence Interval NA to NA | Minutes | |
| Time to Meaningful Pain Relief | ACE ER 1500 mg | 84.675 | 95% Confidence Interval 66.333 to 120.633 | Minutes | |
| Duration of Pain Relief | Placebo | 106.5 | 95% Confidence Interval 99.000 to 132.000 | Minutes | |
| Duration of Pain Relief | ACE ER 1500 mg | NA | 95% Confidence Interval NA to NA | Minutes | |
| Patient Global Evaluation | Placebo | Poor (0) | 63.2 | percentage of participants | |
| Patient Global Evaluation | ACE ER 1500 mg | Poor (0) | 18.3 | percentage of participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 134 | |
| Overall Study | STARTED | ACE ER 1500 mg | 269 | |
| Overall Study | COMPLETED | Placebo | 133 | |
| Overall Study | COMPLETED | ACE ER 1500 mg | 268 | |
| Overall Study | NOT COMPLETED | Placebo | 1 | |
| Overall Study | NOT COMPLETED | ACE ER 1500 mg | 1 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Placebo | 14 | 134 | |
| other | Nausea | Gastrointestinal disorders | ACE ER 1500 mg | 26 | 268 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | ACE ER 1500 mg | ||
| Total, other adverse events | Placebo | 14 | 134 |
| Total, other adverse events | ACE ER 1500 mg | 26 | 268 |
| Total, serious adverse events | Placebo | 0 | 134 |
| Total, serious adverse events | ACE ER 1500 mg | 0 | 268 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| ACE ER 1500 mg vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01960114
GET https://conductscience.org/api/trials/v1/NCT01960114/registered