Trial · NCT05868122
A Study to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy
NCT05868122, Phase 3, Completed, Johnson & Johnson Consumer Inc. (J&JCI)
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy. Trials, record NCT05868122. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05868122
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy
- NCT number
- NCT05868122
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 143 participants, actual
- Lead sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)
- Conditions
- Pain
- Interventions
- Acetaminophen/Naproxen Sodium Fixed Combination, Placebo
- First posted
- 2023-05-22
- Last updated
- 2026-11-03
Source ClinicalTrials.gov
Registered outcomes7
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 Score From 0 to 24 Hours After Dosing (SPID 0-24) | Baseline (0 hour) up to 24 hours post-dose | Time-weighted sum of the pain intensity difference (SPID) scores were calculated using a Pain Intensity-Numerical Rating Scale (PI-NRS) ranging from 0-10 (0 = no pain, 10 = very severe pain) collected at each scheduled timepoint within the specified timeframe. The Pain Intensity Difference (PID) at each time point was derived by subtracting the pain intensity at that time point from the baseline pain intensity. The SPID scores were derived by first multiplying each PID score by the time from the previous timepoint and adding these time weighted PID scores together over the intervals from 0-24 hours. PID is ranging from 0 to 10 point and SPID0-24 ranging from 0 to 240. A higher value of SPID indicated greater pain relief. |
| Secondary | Time-weighted SPID Score From 0 to 12 Hours After Dosing (SPID 0-12) | Baseline (0 hour) up to 12 hours post-dose | Time-weighted sum of the pain intensity difference (SPID) scores were calculated using a Pain Intensity-Numerical Rating Scale (PI-NRS) ranging from 0-10 (0 = no pain, 10 = very severe pain) collected at each scheduled timepoint within the specified timeframe. The Pain Intensity Difference (PID) at each time point was derived by subtracting the pain intensity at that time point from the baseline pain intensity. The SPID scores were derived by first multiplying each PID score by the time from the previous timepoint and adding these time weighted PID scores together over the intervals from 0-12 hours. PID is ranging from 0 to 10 point and SPID0-12 ranging from 0 to120. A higher value of SPID indicated greater pain relief. |
| Secondary | Time-weighted SPID From 0 to 48 Hours After Dosing (SPID 0-48) | Baseline (0 hour) up to 48 hours post-dose | Time-weighted sum of the pain intensity difference (SPID) scores were calculated using a Pain Intensity-Numerical Rating Scale (PI-NRS) ranging from 0-10 (0 = no pain, 10 = very severe pain) collected at each scheduled timepoint within the specified timeframe. The Pain Intensity Difference (PID) at each time point was derived by subtracting the pain intensity at that time point from the baseline pain intensity. The SPID scores were derived by first multiplying each PID score by the time from the previous timepoint and adding these time weighted PID scores together over the intervals from 0-48 hours. PID is ranging from 0 to 10 point and SPID0-48 ranging from 0 to 480. A higher value of SPID indicated greater pain relief. |
| Secondary | Time to Confirmed Perceptible Pain Relief (TCPR) | Up to 12 hours | TCPR is defined as the time (in minutes) to perceptible pain relief as indicated on the first stopwatch, provided that the participant also stopped the second stopwatch indicating meaningful pain relief. |
| Secondary | Time to Meaningful Pain Relief (TMPR) | Up to 12 hours | TMPR is defined as the time (in minutes) to meaningful pain relief as indicated on the second stopwatch. |
| Secondary | Time to First Use of Rescue Medication | Up to 48 hours | Time to first use of rescue medication was measured as the elapsed time from when investigational product was given until the time rescue medication was first given. |
| Secondary | Proportion of Participants Who Use Rescue Medication During the First 12 Hours | Up to 12 hours | Proportion of participants who use rescue medication during the first 12 hours was reported. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT05868122
GET https://conductscience.org/api/trials/v1/NCT05868122/registered