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Efficacy of 300 mg Ibuprofen Prolonged-Release Tablets for the Treatment of Pain After Surgical Removal of Impacted Third Molars

NCT03785756 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2024-06-03

Study results available
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Summary

This is a single centre, randomised, double-blind, double-dummy, parallel group, multiple-dose, active and placebo-controlled efficacy study to evaluate the efficacy and safety of 2×300mg ibuprofen Prolonged Release (PR) tablets in subjects with postoperative dental pain.

Conditions

Interventions

DRUG

Ibuprofen 300 mg Oral Tablet

2 × 300 mg tablets at Hours 0 and 12

DRUG

Ibuprofen 200 mg Oral Tablet

2 × 200 mg tablets at Hours 0, 8, and 16

DRUG

Placebo of PR tablet

2 tablets up to four times in 24 hours

DRUG

Placebo of IR tablet

2 tablets up to four times in 24 hours

Sponsors & Collaborators

  • Premier Research Group plc

    collaborator UNKNOWN

  • Reckitt Benckiser Healthcare (UK) Limited

    lead INDUSTRY

Principal Investigators

  • Todd Bertoch, MD · JBR Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-29
Primary Completion
2020-02-20
Completion
2020-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03785756 on ClinicalTrials.gov