Trial intelligence / Profile preview

Efficacy of Ibuprofen Prolonged-Release for Postoperative Dental Pain

NCT03785756Phase 3

Key facts

Status: Completed
Start: Apr 2019
Primary completion: Feb 2020
Countries: 1
Sponsor: Reckitt
Modality: Small Molecules

Drugs: ibuprofen
Conditions: postoperative dental pain

Overview

Phase 3, randomised, double-blind trial of ibuprofen in postoperative dental pain (3 arms), sponsored by Reckitt. Primary endpoint: Summed Pain Intensity Difference Over 0 to 12 Hours. Started Apr 2019; status: completed.

Design

3 arms

Study design: RandomizedDouble-blind

Prolonged Release Group
Ibuprofen 2x300mg PR Q12h
Immediate Release Group
Ibuprofen 2x200mg IR Q8h
Placebo Group
Placebo matching PR and IR regimens

Who it enrols

Adults aged 18-50 undergoing extraction of 2 or more third molars (at least one mandibular impacted) with moderate to severe postoperative pain.

Endpoints

Primary

Summed Pain Intensity Difference Over 0 to 12 Hours0-12 hours

Secondary

Summed Pain Intensity Difference0-8 hours
Sum of Total Pain Relief0-24 hours
Summed Pain Relief and Intensity Difference0-24 hours
Number of Subjects With Response to Study Drug0-8 hours
Numeric Rating Scale Pain Intensity Difference0-24 hours
Pain Intensity Score0-24 hours
Pain Relief0-24 hours
Peak Pain Relief0-24 hours

Results

Primary endpoints met

Beyond the preview

Go deeper on NCT03785756.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT03785756.