Phase 2
Completed N=202
Study of Diclofenac Capsules to Treat Dental Pain
Dental Pain
Source: ClinicalTrials.gov NCT00985439 ↗
Enrolled (actual)
202
Serious AEs
0.0%
Results posted
Mar 2012
Primary outcomePrimary: Total Patient Pain Relief Over 0 to 12 Hours. — 17.770; 16.893; 14.685; 5.486 units on a scale — p=<0.001
Summary
The purpose of this study is to determine whether Diclofenac Test Formulation Capsules are safe and effective for the treatment of dental pain.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Patient Pain Relief Over 0 to 12 Hours. |
17.770; 16.893; 14.685; 5.486 | <0.001 sig |
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
Data sourced from ClinicalTrials.gov (NCT00985439). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.