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NCT05484401 · ClinicalTrials.gov registry record · Phase 3
Ibuprofen Liquid Capsules 2 x 200 mg Efficacy and PK/PD Study in Surgical Removal of Impacted Third Molars
A Phase 3 study of Tooth Diseases and Tooth, Impacted, sponsored by Reckitt Benckiser Healthcare (UK) Limited.
- Completed
- Registry status
- Phase 3
- Development phase
- 294
- Enrollment target
- 1
- Study location
NCT05484401: Completed Phase 3 study of Tooth Diseases and Tooth, Impacted, sponsored by Reckitt Benckiser Healthcare (UK) Limited.
NCT05484401 is a Phase 3 study of Tooth Diseases and Tooth, Impacted that has completed, run by Reckitt Benckiser Healthcare (UK) Limited. The registered enrollment target is 294 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05484401, a Phase 3 study of Tooth Diseases and Tooth, Impacted, has completed, sponsored by Reckitt Benckiser Healthcare (UK) Limited.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 294 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
SPID0-8 will be used to compare the test product against the placebo product. Pain Intensity Difference (Difference in NRS for baseline and each timepoint) will be plotted against timepoint up to the 8 hour timepoint, the SPID0-8 will be take as the area under the curve. The NRS will be used to assess the Pain Intensity, the NRS for pain is an 11-point scale (0-10) where a higher score indicates a greater amount of pain.
Conditions Studied
Interventions
- OTHER Placebo Tablets
- DRUG Ibuprofen 200Mg Oral Cap
- DRUG Ibuprofen 200Mg Oral Tablet
- OTHER Placebo Liquid Capsule
Study Locations (1)
Utah
- JBR Clinical Research - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 294 participants |
| Start Date | 2022-08-09 |
| Est. Completion | 2023-06-15 |
| Phase | Phase 3 |
What the finished NCT05484401 record still lists
NCT05484401 is an interventional study that assigns participants to a tested intervention. The registered 294 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% lower).
The record links to 3 conditions, with Tooth Diseases appearing as the primary indexed condition, and to 4 interventions - of which Placebo Tablets is the first listed.
NCT05484401 reports a single indexed study location in Utah.
Frequently Asked Questions
What is clinical trial NCT05484401 about?
NCT05484401 is a clinical study titled "Ibuprofen Liquid Capsules 2 x 200 mg Efficacy and PK/PD Study in Surgical Removal of Impacted Third Molars". 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 dent...
What is the current status of trial NCT05484401?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 294 participants. The study started on 2022-08-09. Estimated completion is 2023-06-15.
What conditions does trial NCT05484401 study?
This clinical trial studies the following conditions: Tooth Diseases, Tooth, Impacted, Stomatognathic Diseases.
What interventions are being tested in trial NCT05484401?
The interventions under investigation include: Placebo Tablets (OTHER), Ibuprofen 200Mg Oral Cap (DRUG), Ibuprofen 200Mg Oral Tablet (DRUG), Placebo Liquid Capsule (OTHER).
Who is sponsoring clinical trial NCT05484401?
This trial is sponsored by Reckitt Benckiser Healthcare (UK) Limited, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05484401 being conducted?
This trial has 1 study location across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05484401's enrollment target sits among peer trials
294 1166th of 2000 higher than 835 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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