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

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 |
- 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.

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

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
United States, Texas | |
Premier Research Group Limited | |
Austin, Texas, United States, 78705 |
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 |
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