Ibuprofen Liquid Capsules 2 x 200 mg Efficacy and PK/PD Study in Surgical Removal of Impacted Third Molars
Trial Summary
What is the purpose of this trial?
This trial tests the effectiveness of two liquid-filled ibuprofen capsules in people who have moderate to severe pain after having their wisdom teeth removed. Ibuprofen helps reduce pain and swelling by blocking substances in the body that cause these symptoms. The study aims to see how well this form of ibuprofen works compared to regular ibuprofen tablets. Soluble ibuprofen provided an earlier onset of pain relief than ibuprofen tablets.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications that could affect pain relief assessments, such as antidepressants, sedatives, or other pain relievers. You also need to avoid medications that might interact with the study drug, like aspirin, other NSAIDs, and certain heart and blood pressure medications.
What data supports the effectiveness of the drug Ibuprofen?
Is ibuprofen generally safe for humans?
How does the drug ibuprofen differ from other treatments for pain relief?
Research Team
Todd Bertoch, MD
Principal Investigator
JBR Clinical Research
Eligibility Criteria
Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo surgical removal of impacted third molars and receive a single dose of study medication
Immediate Post-Treatment Monitoring
Participants are monitored for pain relief and adverse events for 12 hours post-dose
Follow-up
Participants return for a follow-up visit for physical assessment and adverse event monitoring
Treatment Details
Interventions
- Ibuprofen
Ibuprofen is already approved in United States, Canada, European Union, Japan, China, Switzerland for the following indications:
- Pain relief
- Fever reduction
- Inflammation
- Pain relief
- Fever reduction
- Inflammation
- Pain relief
- Fever reduction
- Inflammation
- Pain relief
- Fever reduction
- Inflammation
- Pain relief
- Fever reduction
- Inflammation
- Pain relief
- Fever reduction
- Inflammation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Reckitt Benckiser Healthcare (UK) Limited
Lead Sponsor
Premier Research Group plc
Industry Sponsor
John Ratliff
Premier Research Group plc
Chief Executive Officer since 2024
MBA
Dr. Milena Kanova-Petrova
Premier Research Group plc
Chief Medical Officer since 2024
MD