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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
69,065 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are being monitored for this experiment?

"That is correct, the clinical trial indicated on clinicaltrials.gov is still looking for patients. The study was posted on 8/9/2022 and updated as recently as 8/22/2022. They are hoping to enroll 294 people at 1 location."

Answered by AI

What are the objectives of this research?

"The sponsor of this study, Reckitt Benckiser Healthcare (UK) Limited, is measuring the main objective over a 0-8 hour period. This will be done by assessing the Summed Pain Intensity Difference 0-8 hours (SPID0-8) vs placebo using the Numeric Rating Scale (NRS) for pain. Additionally, the study will also look at secondary outcomes including Time to onset of pain relief using double stopwatch method vs Placebo and Proportion of subjects using rescue medication vs Active Comparator. The former is defined as Time to onset of meaningful pain relief (measured as time to perceptible"

Answered by AI

Is Ibuprofen 200Mg Oral Cap known to cause any serious side effects?

"Ibuprofen 200Mg Oral Cap is considered safe."

Answered by AI

Are there any eligibility requirements to participate in this clinical trial?

"Eligible patients for this research should have dental diseases and be between 16 to 55 years old. In total, the study will allow up to 294 individuals to participate."

Answered by AI

Will this study include any individuals above the age of 55?

"In order to qualify for this trial, patients must be aged 16-55. If you are not in this age bracket, there are 17 other trials specifically designed for people under 18 and 19 additional trials available for those over 65."

Answered by AI

Can people with the disease still enroll in the trial?

"That is correct. The clinicaltrials.gov website currently has this trial listed as open and recruiting patients. This trial was originally posted on 8/9/2022 and updated on 8/22/2022. They are looking to enroll 294 individuals at 1 site."

Answered by AI
~110 spots leftby Apr 2025