Phase 2 N=254 Randomized Triple-blind Treatment

Study of Naproxen Capsules to Treat Dental Pain

Dental Pain

Bottom Line

View on ClinicalTrials.gov: NCT01229228 ↗

Enrolled (actual)

254

Serious AEs

0.4%

Results posted

Mar 2012

Primary outcome: Primary: Analysis of Total Pain Relief (TOTPAR) Over 0 to 12 Hours (TOTPAR-12) After Time 0 — 25.868; 31.948; 24.373; 28.549 units on a scale — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Naproxen Test (Drug); Naprosyn (Drug); Placebo (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Iroko Pharmaceuticals, LLC
Primary completion: Apr 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Analysis of Total Pain Relief (TOTPAR) Over 0 to 12 Hours (TOTPAR-12) After Time 0	25.868; 31.948; 24.373; 28.549; 9.531	<0.001 sig

Summary

The purpose of the study is to determine whether Naproxen Test Formulation Capsules are safe and effective for the treatment of dental pain.

Eligibility Criteria

Inclusion Criteria

Patient is male or female between 18 and 50 years of age
For women of child-bearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control
Patient requires extraction of 2 or more third molars
Patient must be willing to stay at the study site overnight

Exclusion Criteria

Patient has hypersensitivity, allergy, or clinically significant intolerance to any medications to be used in the study, or related drugs
Patient has a current disease or history of a disease that will impact the study or the patient's well-being
Patient has used or intends to use any of the medications that are prohibited by the protocol
Patient has a history of drug or alcohol abuse or dependence, or patient has a positive urine drug screen or alcohol breathalyzer test
Patient has taken another investigational drug within 30 days prior to screening

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01229228). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.