Study of Naproxen Capsules to Treat Dental Pain

Phase 2

Completed

• Conditions: Dental Pain
• Interventions: Drug: Naprosyn; Drug: Placebo; Drug: Naproxen Test

• Registration Number: NCT01229228
• Lead Sponsor: Iroko Pharmaceuticals, LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-25
• Study First Submitted QC: 2010-10-26
• Study First Posted: 2010-10-27
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Results First Submitted: 2011-11-22
• Status Verified: 2012-03
• Results First Submitted QC: 2012-03-01
• Results First Posted: 2012-03-29
• Last Update Submitted: 2012-05-15
• Last Update Posted: 2012-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 254

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Naprosyn 250 mg	Naprosyn	-
Naprosyn 500 mg	Naprosyn	-
Placebo	Placebo	-
Naproxen Test (lower dose)	Naproxen Test	200-mg
Naproxen Test (upper dose)	Naproxen Test	400-mg (2 x 200-mg)

Primary Outcome Measures

Name	Time	Method
Analysis of Total Pain Relief (TOTPAR) Over 0 to 12 Hours (TOTPAR-12) After Time 0	Over 0 to 12 Hours	Total pain relief as computed as a time-weighted sum of individual patient pain relief scores at each timepoint from 0-12 hours.; Values for TOTPAR are measured from 0 to 4 on the Pain Relief Scale 0 None Min; 1 A little; 2 Some; 3 A lot; 4 Complete Max; The TOTPAR is a weighted measure of the observations; the minimum possible value is 0 and the maximum possible value is 60.

Trial Locations

Locations (1)

Premier Research Group Limited; 🇺🇸 Austin, Texas, United States