294 Participants Needed

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

MK
Overseen ByMamtha Kunshetty, BDS PDGP
Age: < 65
Sex: Any
Trial Phase: Phase 3
Sponsor: Reckitt Benckiser Healthcare (UK) Limited
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 7 JurisdictionsThis treatment is already approved in other countries

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?

Research shows that ibuprofen is effective in reducing pain, as seen in studies where it provided significant pain relief in patients with chronic wounds and rheumatic conditions. Additionally, ibuprofen formulations are absorbed quickly, which can lead to faster pain relief.12345

Is ibuprofen generally safe for humans?

Ibuprofen is generally considered safe for humans when used as directed, with very few reports of adverse effects. However, misuse or abuse, especially in combination with codeine, can lead to serious health issues like kidney problems and low potassium levels.678910

How does the drug ibuprofen differ from other treatments for pain relief?

Ibuprofen sodium, a new formulation of ibuprofen, is absorbed faster than standard ibuprofen tablets, providing quicker pain relief. This makes it unique compared to other pain relief options that may not offer such rapid onset of action.124611

Research Team

TB

Todd Bertoch, MD

Principal Investigator

JBR Clinical Research

Eligibility Criteria

Inclusion Criteria

Has a body weight ≥ 45 kg and a BMI ≥17 kg/m2 and ≤ 30 kg/m2.
Subject has provided written informed consent (for subjects who are below the age of legal consent, parent(s) or legally authorized representative(s) provides written informed consent and the subject provides written assent).
Subject is male or female and aged ≥16 and ≤55 years of age at screening.
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Exclusion Criteria

In the opinion of the investigator, any subject with a clinically relevant history of peptic ulceration, gastrointestinal bleeding or perforation, heart failure, renal or hepatic failure, uncontrolled hypertension, nasal polyps, or chronic rhinitis.
A positive urine drugs of abuse test at screening and during the study (with the exception of a positive drugs of abuse screen that is a consequence of permitted prescription medicines) or positive alcohol breathalyser test during the study.
If female, has a positive pregnancy test at screening (serum) or on the day of surgery prior to surgery (urine), or is lactating.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants undergo surgical removal of impacted third molars and receive a single dose of study medication

1 day
1 visit (in-person)

Immediate Post-Treatment Monitoring

Participants are monitored for pain relief and adverse events for 12 hours post-dose

12 hours
Overnight stay (in-person)

Follow-up

Participants return for a follow-up visit for physical assessment and adverse event monitoring

1 week
1 visit (in-person)

Treatment Details

Interventions

  • Ibuprofen
Participant Groups
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

Ibuprofen is already approved in United States, Canada, European Union, Japan, China, Switzerland for the following indications:

🇺🇸
Approved in United States as Advil for:
  • Pain relief
  • Fever reduction
  • Inflammation
🇨🇦
Approved in Canada as Motrin for:
  • Pain relief
  • Fever reduction
  • Inflammation
🇪🇺
Approved in European Union as Nurofen for:
  • Pain relief
  • Fever reduction
  • Inflammation
🇯🇵
Approved in Japan as Ibuprofen for:
  • Pain relief
  • Fever reduction
  • Inflammation
🇨🇳
Approved in China as Ibuprofen for:
  • Pain relief
  • Fever reduction
  • Inflammation
🇨🇭
Approved in Switzerland as Ibuprofen for:
  • Pain relief
  • Fever reduction
  • Inflammation

Find a Clinic Near You

Who Is Running the Clinical Trial?

Reckitt Benckiser Healthcare (UK) Limited

Lead Sponsor

Trials
33
Recruited
5,600+

Premier Research Group plc

Industry Sponsor

Trials
65
Recruited
74,200+

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

Findings from Research

Intravenous ibuprofen (IVIB) provides significantly higher plasma levels compared to oral ibuprofen, leading to better postoperative pain management and reduced opioid use in a review of 9 studies involving 1062 patients.
IVIB has a favorable safety profile, with fewer adverse events and improved recovery outcomes, making it a strong candidate for inclusion in multimodal pain management strategies for pre- and postoperative care.
Narrative Summary of Recently Published Literature on Intravenous Ibuprofen.Southworth, SR., Sellers, JA.[2021]
Over a 10-year period, a total of 29,656,286 units of various ibuprofen formulations were sold in Poland, with only 5 spontaneous reports of adverse effects, indicating that ibuprofen is a very safe medication with rare side effects.
The study suggests that while ibuprofen is generally safe, the current monitoring system for adverse effects in Poland is insufficient and requires enhancements to better detect potential issues.
Safety of oral ibuprofen--analysis of data from the spontaneous reporting system in Poland.Kuchari, E., Han, S., Karłowicz-Bodalska, K., et al.[2022]
The European Medicines Agency's Pharmacovigilance Risk Assessment Committee has issued a warning about the serious risks associated with the combination of codeine and ibuprofen, particularly concerning renal and gastrointestinal harms.
This warning highlights the need for careful consideration of the safety profile of this medication combination, emphasizing potential adverse effects that could impact patient health.
Safety warning: combination products containing codeine and ibuprofen.[2023]

References

Ibuprofen sodium is absorbed faster than standard Ibuprofen tablets: results of two open-label, randomized, crossover pharmacokinetic studies. [2022]
Bioequivalence study of three ibuprofen formulations after single dose administration in healthy volunteers. [2022]
Indoprofen in rheumatic patients with acute episodes: a multicentre trial. [2017]
Reducing wound pain in venous leg ulcers with Biatain Ibu: a randomized, controlled double-blind clinical investigation on the performance and safety. [2022]
Narrative Summary of Recently Published Literature on Intravenous Ibuprofen. [2021]
Safety of oral ibuprofen--analysis of data from the spontaneous reporting system in Poland. [2022]
Safety warning: combination products containing codeine and ibuprofen. [2023]
Hypokalaemia in ibuprofen and codeine phosphate abuse. [2020]
Severe hypokalaemia and weakness due to Nurofen misuse. [2020]
10.United Statespubmed.ncbi.nlm.nih.gov
Hypokalaemia and Renal Tubular Acidosis due to Abuse of Nurofen Plus. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Onset of analgesia and efficacy of ibuprofen sodium in postsurgical dental pain: a randomized, placebo-controlled study versus standard ibuprofen. [2022]