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Study of Naproxen Capsules to Treat Dental Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01229228
Recruitment Status : Completed
First Posted : October 27, 2010
Results First Posted : March 29, 2012
Last Update Posted : May 22, 2012
Sponsor:
Information provided by (Responsible Party):
Iroko Pharmaceuticals, LLC

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dental Pain Drug: Naproxen Test Drug: Naprosyn Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 254 participants
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
Study Start Date : October 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Naproxen Test (lower dose)
200-mg
 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


Outcome Measures
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Primary Outcome Measures :
  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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01229228


Locations
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United States, Texas
Premier Research Group Limited
Austin, Texas, United States, 78705
Sponsors and Collaborators
Iroko Pharmaceuticals, LLC
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Iroko Pharmaceuticals, LLC
ClinicalTrials.gov Identifier: NCT01229228    
Other Study ID Numbers: NAP2-08-03
First Posted: October 27, 2010    Key Record Dates
Results First Posted: March 29, 2012
Last Update Posted: May 22, 2012
Last Verified: March 2012
Additional relevant MeSH terms:
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Toothache
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Pain
Neurologic Manifestations
Naproxen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
 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