Trials / Completed
CompletedNCT04640376
Paracetamol UNIFLASH for Buccal Use Phase III Trial in Acute Pain Due to a Tooth Extraction
Comparison of the Analgesic Effect of a New Paracetamol Formulation (Paracetamol UNIFLASH) for Buccal Use and Two Different Doses of an Oral Paracetamol Form Controlled Versus Placebo in Patients Suffering From Moderate Pain Due to a Tooth Extraction.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 407 (actual)
- Sponsor
- Unither Pharmaceuticals, France · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study aims to evaluate the analgesic efficacy of single dose of a new paracetamol formulation (paracetamol UNIFLASH) for buccal use in comparison to two different doses of an oral paracetamol form controlled versus placebo.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Paracetamol Uniflash 125mg | Oromucosal solution 1.25 mL for buccal use |
| DRUG | Panadol 500 MG Oral Tablet X1 | Tablet masked in capsule |
| DRUG | Panadol 500 MG Oral Tablet X2 | Tablet masked in capsule |
| DRUG | Placebo | Dummy treatment |
Timeline
- Start date
- 2021-03-24
- Primary completion
- 2022-11-08
- Completion
- 2022-11-10
- First posted
- 2020-11-23
- Last updated
- 2022-11-14
Locations
20 sites across 4 countries: France, Italy, Poland, Spain
Source: ClinicalTrials.gov record NCT04640376. Inclusion in this directory is not an endorsement.