Study of Naproxen Capsules to Treat Dental Pain - Full Text View

Purpose

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:

Drug Information available for: Naproxen Naproxen sodium

U.S. FDA Resources

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) 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

Eligibility


Ages Eligible for Study:	18 Years to 50 Years (Adult)
Genders Eligible for Study:	Both
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

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 ClinicalTrials.gov identifier: NCT01229228

Locations


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 ClinicalTrials.gov Identifier (NCT Number):

Young CL, Strand V, Altman R, Daniels S. A phase 2 study of naproxen submicron particle capsules in patients with post-surgical dental pain. Adv Ther. 2013 Oct;30(10):885-96. doi: 10.1007/s12325-013-0057-9. Epub 2013 Oct 15.


Responsible Party:	Iroko Pharmaceuticals, LLC
ClinicalTrials.gov 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:


Toothache Tooth Diseases Stomatognathic Diseases Facial Pain Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms 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

ClinicalTrials.gov processed this record on September 23, 2016