Study of Diclofenac Capsules to Treat Dental Pain
Information source: Iroko Pharmaceuticals, LLC
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dental Pain
Intervention: Diclofenac Test (lower dose) (Drug); Diclofenac Test (upper dose) (Drug); Celecoxib (Drug); Placebo (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Iroko Pharmaceuticals, LLC Overall contact:
George Van Lear, Ph.D., Phone: 267-546-3076, Email: gvanlear@iroko.com
Summary
The purpose of this study is to determine whether Diclofenac Test Formulation Capsules are
safe and effective for the treatment of dental pain.
Clinical Details
Official title: A Phase 2, Randomized, Double-Blind, Single-Dose, Parallel-Group, Active- and Placebo-Controlled Study of Diclofenac [Test] Capsules for the Treatment of Pain After Surgical Removal of Impacted Third Molars
Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Primary outcome: Total Pain Relief (TOTPAR)
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
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
Locations and Contacts
George Van Lear, Ph.D., Phone: 267-546-3076, Email: gvanlear@iroko.com
Premier Research Group Limited, Austin, Texas 78705, United States; Recruiting
Stephen E. Daniels, DO, Phone: 512-320-1600, Email: Stephen.daniels@premier-research.com
Stephen E. Daniels, DO, Principal Investigator
Additional Information
Starting date: September 2009
Ending date: November 2009
Last updated: September 25, 2009
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