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Study of Naproxen Capsules to Treat Dental Pain

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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 Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Dental Pain
Interventions Drug: Naproxen Test
Drug: Naprosyn
Drug: Placebo
Enrollment 254
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Naproxen Test (Lower Dose) Naproxen Test (Upper Dose) Naprosyn 250 mg Naprosyn 500 mg Placebo
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified]
Period Title: Overall Study
Started 51 51 50 51 51
Completed 50 51 49 51 50
Not Completed 1 0 1 0 1
Arm/Group Title Naproxen Test (Lower Dose) Naproxen Test (Upper Dose) Naprosyn 250 mg Naprosyn 500 mg Placebo Total
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 51 51 50 51 51 254
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 51 participants 50 participants 51 participants 51 participants 254 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
51
 100.0%
51
 100.0%
50
 100.0%
51
 100.0%
51
 100.0%
254
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 51 participants 51 participants 50 participants 51 participants 51 participants 254 participants
21.1  (2.93) 21.1  (3.29) 20.7  (2.20) 20.9  (2.88) 21.1  (3.02) 21.0  (2.87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 51 participants 50 participants 51 participants 51 participants 254 participants
Female
33
  64.7%
30
  58.8%
32
  64.0%
21
  41.2%
32
  62.7%
148
  58.3%
Male
18
  35.3%
21
  41.2%
18
  36.0%
30
  58.8%
19
  37.3%
106
  41.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 51 participants 51 participants 50 participants 51 participants 51 participants 254 participants
51 51 50 51 51 254
1.Primary Outcome
Title Analysis of Total Pain Relief (TOTPAR) Over 0 to 12 Hours (TOTPAR-12) After Time 0
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Naproxen Test (Lower Dose) Naproxen Test (Upper Dose) Naprosyn 250 mg Naprosyn 500 mg Placebo
Hide Arm/Group Description:
200-mg single dose
400-mg (2 x 200-mg)
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 50 51 50 51 51
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
25.868
(21.943 to 29.792)
31.948
(28.065 to 35.831)
24.373
(20.442 to 28.304)
28.549
(24.660 to 32.439)
9.531
(5.646 to 13.416)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naproxen Test (Upper Dose), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 22.417
Confidence Interval (2-Sided) 95%
16.923 to 27.910
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.7891
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Naproxen Test (Lower Dose) Naproxen Test (Upper Dose) Naprosyn 250 mg Naprosyn 500 mg Placebo
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
Naproxen Test (Lower Dose) Naproxen Test (Upper Dose) Naprosyn 250 mg Naprosyn 500 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Naproxen Test (Lower Dose) Naproxen Test (Upper Dose) Naprosyn 250 mg Naprosyn 500 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/50 (2.00%)   0/51 (0.00%)   0/50 (0.00%)   0/51 (0.00%)   0/51 (0.00%) 
General disorders           
Adverse drug reaction  1  1/50 (2.00%)  0/51 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  0/51 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9.1 or higher
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Naproxen Test (Lower Dose) Naproxen Test (Upper Dose) Naprosyn 250 mg Naprosyn 500 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   28/51 (54.90%)   27/51 (52.94%)   25/50 (50.00%)   26/51 (50.98%)   31/51 (60.78%) 
Gastrointestinal disorders           
Nausea  1  6/51 (11.76%)  2/51 (3.92%)  8/50 (16.00%)  6/51 (11.76%)  9/51 (17.65%) 
Vomiting  1  0/51 (0.00%)  0/51 (0.00%)  1/50 (2.00%)  1/51 (1.96%)  3/51 (5.88%) 
Injury, poisoning and procedural complications           
Post procedural complication  1  0/51 (0.00%)  4/51 (7.84%)  3/50 (6.00%)  1/51 (1.96%)  3/51 (5.88%) 
Post procedural swelling  1  16/51 (31.37%)  12/51 (23.53%)  11/50 (22.00%)  15/51 (29.41%)  9/51 (17.65%) 
Nervous system disorders           
Dizziness  1  5/51 (9.80%)  3/51 (5.88%)  2/50 (4.00%)  0/51 (0.00%)  6/51 (11.76%) 
Headache  1  5/51 (9.80%)  6/51 (11.76%)  6/50 (12.00%)  5/51 (9.80%)  9/51 (17.65%) 
Respiratory, thoracic and mediastinal disorders           
Nasopharyngitis  1  0/51 (0.00%)  3/51 (5.88%)  0/50 (0.00%)  1/51 (1.96%)  2/51 (3.92%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9.1 or higher
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Steven Jensen
Organization: Iroko Pharmaceuticals, LLC
Phone: 267-546-3003
EMail: sjensen@iroko.com
Layout table for additonal information
Responsible Party: Iroko Pharmaceuticals, LLC
ClinicalTrials.gov Identifier: NCT01229228     History of Changes
Other Study ID Numbers: NAP2-08-03
First Submitted: October 25, 2010
First Posted: October 27, 2010
Results First Submitted: November 22, 2011
Results First Posted: March 29, 2012
Last Update Posted: May 22, 2012