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Nonsteroidal Anti-inflammatory Drug

Ibuprofen 200Mg Oral Cap for Tooth Decay

Phase 3
Waitlist Available
Led By Todd Bertoch, MD
Research Sponsored by Reckitt Benckiser Healthcare (UK) Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10-90mins
Awards & highlights

Study Summary

This trial is testing if a new form of ibuprofen is effective and safe for treating dental pain.

Eligible Conditions
  • Tooth Decay
  • Impacted Tooth
  • Oral and Maxillofacial Diseases

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10-90mins
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10-90mins for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Summed Pain Intensity Difference 0-8 hours (SPID0-8) vs placebo using the Numeric Rating Scale (NRS) for pain
Time to Meaningful pain relief vs active comparator using double stopwatch method
Secondary outcome measures
Analgesics
Occupancy Time
PK Subset: AUC0-t will be evaluate for each treatment (test and active comparator)
+39 more
Other outcome measures
Incidence of Treatment Emergent Adverse Events as assessed by patient response to questions and spontaneous reporting of TEAEs
Vital signs measurements - Blood pressure in mm/Hg
Vital signs measurements - Body Temperature in ºC
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Test ProductExperimental Treatment2 Interventions
Ibuprofen 200mg Oral Liquid Capsule, Placebo of Ibuprofen 200mg Oral Tablet
Group II: Reference ProductActive Control2 Interventions
Ibuprofen 200mg Oral Tablet, Placebo of Ibuprofen 200mg Oral Liquid Capsule
Group III: PlaceboPlacebo Group2 Interventions
Placebo of Ibuprofen 200mg Oral Liquid Capsule, Placebo of Ibuprofen 200mg Oral Tablet
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibuprofen 200Mg Oral Cap
2022
Completed Phase 3
~300

Find a Location

Who is running the clinical trial?

Premier Research Group plcIndustry Sponsor
62 Previous Clinical Trials
73,548 Total Patients Enrolled
Reckitt Benckiser Healthcare (UK) LimitedLead Sponsor
30 Previous Clinical Trials
4,515 Total Patients Enrolled
Todd Bertoch, MDPrincipal InvestigatorJBR Clinical Research
6 Previous Clinical Trials
1,319 Total Patients Enrolled
~107 spots leftby Jun 2025
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