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Ibuprofen Liquid Capsules 2 x 200 mg Efficacy and PK/PD Study in Surgical Removal of Impacted Third Molars

NCT05484401 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 294

Last updated 2023-06-22

No results posted yet for this 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.

Conditions

  • Tooth, Impacted
  • Tooth Diseases
  • Stomatognathic Diseases

Interventions

DRUG

Ibuprofen 200Mg Oral Cap

2 x 200mg Liquid Capsules once in 12 hours

DRUG

Ibuprofen 200Mg Oral Tablet

2 x 200mg Tablets once in 12 hours

OTHER

Placebo Liquid Capsule

2 x Liquid Capsules once in 12 hours

OTHER

Placebo Tablets

2 x Tablets once in 12 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
16 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-09
Primary Completion
2023-06-15
Completion
2023-06-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT05484401 on ClinicalTrials.gov