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NCT05868122

A Study to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy

StatusCompleted
PhasePhase 3
Primary completion
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Record History

All 15 versions: 8 with changes below, 7 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Results posted: Nov 3, 2026 Show 5 more changesShow less
    • Interventions: Acetaminophen/Naproxen Sodium Fixed Combination (Drug), Placebo (Drug) to Acetaminophen/Naproxen Sodium Fixed Combination (Drug), Placebo (Drug)
    • Eligibility criteria expanded, about 23 words
    • Secondary endpoints revised (6)
    • Primary endpoint revised
    • Site details revised at 1 of 4 sites
  2. Enrollment target: 122 to 143
    • Primary completion date: May 30, 2024 to May 25, 2024
    v14
  3. Trial status: Recruiting to Completed
    • Enrollment target: estimated 120 to confirmed 122
    • Primary and study completion dates changed from estimate of Jun 15, 2024 to May 30, 2024
    • Study sites revised (4)
    v12
  4. Primary and study completion dates pushed to Jun 15, 2024v11
  5. Primary completion date: Feb 15, 2024 to Apr 15, 2024
    • Study completion date: Mar 1, 2024 to Apr 30, 2024
    v10
Show 2 earlier versionsHide 2 earlier versions
  1. Study completion date: Sep 2, 2024 to Mar 1, 2024v6
  2. Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Feb 1, 2024 to Feb 15, 2024
    • Start date changed from estimate of Sep 1, 2023 to Sep 7, 2023
    • Site details revised at 4 of 4 sites
    v5
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Time-weighted Sum of Pain Intensity Difference Score From 0 to 24 Hours After Dosing (SPID 0-24)
Timeframe: Baseline (0 hour) up to 24 hours post-dose

Secondary (6)

Time-weighted SPID Score From 0 to 12 Hours After Dosing (SPID 0-12)
Time-weighted SPID From 0 to 48 Hours After Dosing (SPID 0-48)
Time to Confirmed Perceptible Pain Relief (TCPR)
Time to Meaningful Pain Relief (TMPR)
Time to First Use of Rescue Medication
Show 1 moreShow less
Proportion of Participants Who Use Rescue Medication During the First 12 Hours

Arms and interventions

Acetaminophen/Naproxen Sodium Fixed CombinationExperimental

Participants will receive oral doses of two Acetaminophen/Naproxen Sodium Fixed Combination tablets taken with water. Multiple doses will be administered over a 48-hour period.

PlaceboPlacebo comparator

Participants will receive oral doses of two placebo tablets taken with water. Multiple doses will be administered over a 48-hour period.

Drugs: Acetaminophen/Naproxen Sodium Fixed Combination, Placebo

Sites

4 sites in 1 country