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Towards Predicting the Analgesic Response to Ibuprofen Following Third-molar Extraction

NCT03893175 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2025-07-24

No results posted yet for this study

Summary

This research study will evaluate inter-individual variability in the analgesic response to the non-steroidal anti-inflammatory drug (NSAID) ibuprofen after third molar extraction surgery. It will also investigate demographic, clinical, genetic, and environmental factors that cause this variability.

Conditions

  • Impacted Third Molar Tooth
  • Pain, Acute

Interventions

DRUG

Ibuprofen

400 mg by mouth every 4 hours for 2 days after third molar extraction and then as needed for pain up to 7 days after third molar extraction

DRUG

Acetaminophen

500 mg by mouth every 4 hours for 2 days after third molar extraction and then as needed for pain up to 7 days after third molar extraction

DRUG

Placebo

By mouth

DRUG

Oxycodone

5 mg by mouth every 6 hours as needed for pain

Sponsors & Collaborators

Principal Investigators

  • Tilo Grosser, MD · University of Pennsylvania

  • Katherine N Theken, PharmD, PhD · University of Pennsylvania

  • Elliot V Hersh, DMD, MS, PhD · University of Pennsylvania

  • John Farrar, MD, PhD · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-05-10
Primary Completion
2022-03-02
Completion
2022-03-02
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

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 NCT03893175 on ClinicalTrials.gov