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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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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 ]

    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   (Adult)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional relevant MeSH terms:
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on September 21, 2017