Study of Naproxen Capsules to Treat Dental Pain

Dental Pain Clinical Trial

Official title:

A Phase 2, Randomized, Double-Blind, Single-Dose, Parallel-Group, Active- and Placebo-Controlled Study of Naproxen [Test] Capsules for the Treatment of Pain After Surgical Removal of Impacted Third Molars

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01229228
• Other study ID #: NAP2-08-03
• Status: Completed
• Phase: Phase 2
• First received: October 25, 2010
• Last updated: May 15, 2012
• Start date: October 2010
• Est. completion date: April 2011

Study information

• Verified date: March 2012
• Source: Iroko Pharmaceuticals, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 254
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Pain
• Toothache

Intervention

Drug:
• Naproxen Test
200-mg single dose
• Naproxen Test
400-mg (2 x 200-mg)
• Naprosyn
single dose
• Naprosyn
single dose
• Placebo
single dose

Locations

Country	Name	City	State
United States	Premier Research Group Limited	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Iroko Pharmaceuticals, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis of Total Pain Relief (TOTPAR) Over 0 to 12 Hours (TOTPAR-12) After Time 0	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.	Over 0 to 12 Hours	No