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Completed

NCT Number: NCT01229228

Study of Naproxen Capsules to Treat Dental Pain

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

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Premier Research Group Limited

Austin, Texas, 78705, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Naproxen Test

Drug

200-mg single dose

Naprosyn

Drug

single dose

Placebo

Drug

single dose

Primary outcomes

  1. Analysis of Total Pain Relief (TOTPAR) Over 0 to 12 Hours (TOTPAR-12) After Time 0

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Iroko Pharmaceuticals, LLC

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 27, 2010
Registry last updated
May 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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