Dental Pain Clinical Trial
Official title:
A Phase 2, Randomized, Double-Blind, Single-Dose, Parallel-Group, Active- and Placebo-Controlled Study of Indomethacin Test Capsules for the Treatment of Pain After Surgical Removal of Impacted Third Molars
Verified date | March 2012 |
Source | Iroko Pharmaceuticals, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to determine whether Indomethacin Test Formulation Capsules are safe and effective for the treatment of dental pain.
Status | Completed |
Enrollment | 203 |
Est. completion date | December 2009 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 50 Years |
Eligibility |
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 for at least 8 hours after dosing of the study drug 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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Premier Research Group Limited | Austin | Texas |
Lead Sponsor | Collaborator |
---|---|
Iroko Pharmaceuticals, LLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total Patient Pain Relief Over 0 to 8 Hours. | Total patient pain relief was assessed as a time-weighted sum of the patient pain assessments at each individual time point from 0-8 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 32. |
8 hours | No |
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