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NCT05868122
A Study to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy
Phase 3 trial testing Acetaminophen/Naproxen Sodium Fixed Combination in Pain in 122 participants. Completed in 30 May 2024.
30 May 2024
Quick facts
| Lead sponsor | Johnson & Johnson Consumer Inc. (J&JCI) |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 122 |
| Start date | 7 September 2023 |
| Primary completion | 30 May 2024 |
| Estimated completion | 30 May 2024 |
| Sites | 4 locations across United States |
Drugs / interventions tested
- Acetaminophen/Naproxen Sodium Fixed Combination — full drug profile →
- Placebo
Conditions studied
- Pain — all drugs for Pain →
Sponsor
Johnson & Johnson Consumer Inc. (J&JCI) — full company profile →
Who can join
Adults 16 to 65, any sex, with Pain. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to evaluate effectiveness of a fixed combination of acetaminophen/naproxen sodium compared with placebo for reduction of pain when administered as multiple doses over a 48-hour period.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05868122
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Acetaminophen/Naproxen Sodium Fixed Combination
Trials testing the same drug.
- NCT05845008 — A Multiple-Dose Safety Study of Fixed Combination of Acetaminophen/Naproxen Sodium in Adolescents With Orthodontic Pain · Phase 3 · withdrawn
- NCT05761574 — A Study of an Acetaminophen/Naproxen Sodium Fixed Combination, Acetaminophen and Naproxen Sodium in Postoperative Dental · Phase 3 · completed
Other recruiting trials for Pain
Currently open trials in the same condition.
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- NCT07487610 — Relationship Between Neuropathic Pain and Geriatric Assessment Parameters in Patients Aged 80 Years and Older · recruiting
- NCT07454993 — The Effect of Music During Colonoscopy · NA · recruiting
Other Johnson & Johnson Consumer Inc. (J&JCI) trials
Trials by the same sponsor.
- NCT06852742 — A Study to Evaluate and Compare the Efficacy of Two Facial Creams on Moderately to Severely Photodamaged Skin · NA · completed
- NCT06734299 — A Study to Evaluate Usage of Mineral Sunscreens With Differentiated Whitening Attributes in Multi-Cultural Skin Tones · NA · completed
- NCT06658847 — A Study to Evaluate the Effect of a Topical Retinol on Epigenetic Changes and Expression of Certain Genes in the Skin Us · NA · completed
- NCT06654102 — A Study to Evaluate the Cutaneous Effects of Deep Ultraviolet A +/- High-Energy Visible Blue Light Exposure · NA · completed
- NCT06318637 — Evaluation of the Acceptability and Feasibility of a Bedtime Routine for Neonates · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05868122 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Johnson & Johnson Consumer Inc. (J&JCI)
- Last refreshed: 15 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05868122.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing