Phase 2
N=203
Phase 2 Study of Indomethacin Capsules to Treat Dental Pain
Dental Pain
Bottom Line
View on ClinicalTrials.gov: NCT00964431 ↗Enrolled (actual)
203
Serious AEs
0.0%
Results posted
Mar 2012
Primary outcome: Primary: Total Patient Pain Relief Over 0 to 8 Hours. — 10.794; 12.564; 14.822; 3.019 units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Celecoxib 400 mg (Drug); Placebo (Drug); Indomethacin Test (lower dose) (Drug); Indomethacin Test (upper dose) (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Iroko Pharmaceuticals, LLC
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Patient Pain Relief Over 0 to 8 Hours. |
10.794; 12.564; 14.822; 3.019 | <0.001 sig |
Summary
The purpose of this study is to determine whether Indomethacin Test Formulation Capsules are safe and effective for the treatment of dental pain.
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 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
Data sourced from ClinicalTrials.gov (NCT00964431). 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.