Study of Naproxen Capsules to Treat Dental Pain

This study has been completed.
Information provided by (Responsible Party):
Iroko Pharmaceuticals, LLC Identifier:
First received: October 25, 2010
Last updated: May 15, 2012
Last verified: March 2012
The purpose of the study is to determine whether Naproxen Test Formulation Capsules are safe and effective for the treatment of dental pain.

Condition Intervention Phase
Dental Pain
Drug: Naproxen Test
Drug: Naprosyn
Drug: Placebo
Phase 2

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

Resource links provided by NLM:

Further study details as provided by Iroko Pharmaceuticals, LLC:

Primary Outcome Measures:
  • Analysis of Total Pain Relief (TOTPAR) Over 0 to 12 Hours (TOTPAR-12) After Time 0 [ Time Frame: Over 0 to 12 Hours ] [ Designated as safety issue: No ]

    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.

Enrollment: 254
Study Start Date: October 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Naproxen Test (lower dose)
Drug: Naproxen Test
200-mg single dose
Experimental: Naproxen Test (upper dose)
400-mg (2 x 200-mg)
Drug: Naproxen Test
400-mg (2 x 200-mg)
Active Comparator: Naprosyn 250 mg Drug: Naprosyn
single dose
Active Comparator: Naprosyn 500 mg Drug: Naprosyn
single dose
Placebo Comparator: Placebo Drug: Placebo
single dose


Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01229228

United States, Texas
Premier Research Group Limited
Austin, Texas, United States, 78705
Sponsors and Collaborators
Iroko Pharmaceuticals, LLC
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Iroko Pharmaceuticals, LLC Identifier: NCT01229228     History of Changes
Other Study ID Numbers: NAP2-08-03 
Study First Received: October 25, 2010
Results First Received: November 22, 2011
Last Updated: May 15, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Facial Pain
Signs and Symptoms
Stomatognathic Diseases
Tooth Diseases
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Gout Suppressants
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on May 02, 2016