Study of Naproxen Capsules to Treat Dental Pain

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Iroko Pharmaceuticals, LLC

ClinicalTrials.gov Identifier:

NCT01229228

First received: October 25, 2010

Last updated: May 15, 2012

Last verified: March 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	October 25, 2010
Last Updated Date	May 15, 2012
Start Date ^ICMJE	October 2010
Primary Completion Date	April 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 15, 2012)	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.
Original Primary Outcome Measures ^ICMJE (submitted: October 26, 2010)	Total Pain Relief (TOTPAR) [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT01229228 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study of Naproxen Capsules to Treat Dental Pain
Official Title ^ICMJE	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
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Dental Pain
Intervention ^ICMJE	Drug: Naproxen Test 200-mg single dose Drug: Naproxen Test 400-mg (2 x 200-mg) Drug: Naprosyn single dose Drug: Placebo single dose
Study Arm (s)	Experimental: Naproxen Test (lower dose) 200-mg Intervention: Drug: Naproxen Test Experimental: Naproxen Test (upper dose) 400-mg (2 x 200-mg) Intervention: Drug: Naproxen Test Active Comparator: Naprosyn 250 mg Intervention: Drug: Naprosyn Active Comparator: Naprosyn 500 mg Intervention: Drug: Naprosyn Placebo Comparator: Placebo Intervention: Drug: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	254
Completion Date	April 2011
Primary Completion Date	April 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 50 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01229228
Other Study ID Numbers ^ICMJE	NAP2-08-03
Has Data Monitoring Committee	No
Responsible Party	Iroko Pharmaceuticals, LLC
Study Sponsor ^ICMJE	Iroko Pharmaceuticals, LLC
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Iroko Pharmaceuticals, LLC
Verification Date	March 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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