Back to resultsStudy of Naproxen Capsules to Treat Dental Pain
Primary Purpose
Dental Pain
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Naproxen Test
Naproxen Test
Naprosyn
Naprosyn
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Dental Pain
Eligibility 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
Sites / Locations
- Premier Research Group Limited
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Naproxen Test (lower dose)
Naproxen Test (upper dose)
Naprosyn 250 mg
Naprosyn 500 mg
Placebo
Arm Description
200-mg
400-mg (2 x 200-mg)
Outcomes
Primary Outcome Measures
Analysis of Total Pain Relief (TOTPAR) Over 0 to 12 Hours (TOTPAR-12) After Time 0
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01229228
First Posted
October 25, 2010
Last Updated
May 15, 2012
Sponsor
Iroko Pharmaceuticals, LLC
1. Study Identification
Unique Protocol Identification Number
NCT01229228
Brief Title
Study of Naproxen Capsules to Treat Dental Pain
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 Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Iroko Pharmaceuticals, LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
254 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Naproxen Test (lower dose)
Arm Type
Experimental
Arm Description
200-mg
Arm Title
Naproxen Test (upper dose)
Arm Type
Experimental
Arm Description
400-mg (2 x 200-mg)
Arm Title
Naprosyn 250 mg
Arm Type
Active Comparator
Arm Title
Naprosyn 500 mg
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Naproxen Test
Intervention Description
200-mg single dose
Intervention Type
Drug
Intervention Name(s)
Naproxen Test
Intervention Description
400-mg (2 x 200-mg)
Intervention Type
Drug
Intervention Name(s)
Naprosyn
Intervention Description
single dose
Intervention Type
Drug
Intervention Name(s)
Naprosyn
Intervention Description
single dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
single dose
Primary Outcome Measure Information:
Title
Analysis of Total Pain Relief (TOTPAR) Over 0 to 12 Hours (TOTPAR-12) After Time 0
Description
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.
Time Frame
Over 0 to 12 Hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Premier Research Group Limited
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24127200
Citation
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.
Results Reference
derived
Learn more about this trial
Study of Naproxen Capsules to Treat Dental Pain
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