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NCT05484401
Ibuprofen Liquid Capsules 2 x 200 mg Efficacy and PK/PD Study in Surgical Removal of Impacted Third Molars
Phase 3 trial testing Ibuprofen 200Mg Oral Cap in Tooth, Impacted in 294 participants. Completed in 15 June 2023.
15 June 2023
Quick facts
| Lead sponsor | Reckitt Benckiser Healthcare (UK) Limited |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 294 |
| Start date | 9 August 2022 |
| Primary completion | 15 June 2023 |
| Estimated completion | 15 June 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Ibuprofen 200Mg Oral Cap — full drug profile →
- Ibuprofen 200Mg Oral Tablet — full drug profile →
- Placebo Liquid Capsule
- Placebo Tablets — full drug profile →
Conditions studied
- Tooth, Impacted — all drugs for Tooth, Impacted →
- Tooth Diseases — all drugs for Tooth Diseases →
- Stomatognathic Diseases — all drugs for Stomatognathic Diseases →
Sponsor
Reckitt Benckiser Healthcare (UK) Limited — full company profile →
Who can join
Adults 16 to 55, any sex, with Tooth, Impacted or Tooth Diseases. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a single centre, three-arm randomised, double-blind, double-dummy, parallel group, single-dose, active and placebo-controlled efficacy and pharmacokinetics/ pharmacodynamics study to evaluate the efficacy and safety of 2 x 200 mg Ibuprofen Liquid Capsules in subjects with post-operative dental pain.
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 NCT05484401
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT05484401 (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 Reckitt Benckiser Healthcare (UK) Limited
- Last refreshed: 22 June 2023
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/NCT05484401.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing