Back to resultsStudy of Diclofenac Capsules to Treat Dental Pain
Primary Purpose
Dental Pain
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Diclofenac Test (lower dose)
Diclofenac Test (upper dose)
Celecoxib 400 mg
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for 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 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
Sites / Locations
- Premier Research Group Limited
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Placebo Comparator
Arm Label
Diclofenac Test (lower dose)
Diclofenac Test (upper dose)
Celecoxib 400 mg
Placebo
Arm Description
One 18-mg Diclofenac Test Capsule and 1 placebo capsule
One 35-mg Diclofenac Test Capsule and 1 placebo capsule
Outcomes
Primary Outcome Measures
Total Patient Pain Relief Over 0 to 12 Hours.
Total patient pain relief was assessed as a time-weighted sum of the patient pain assessments at each individual time point 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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00985439
First Posted
September 25, 2009
Last Updated
May 15, 2012
Sponsor
Iroko Pharmaceuticals, LLC
1. Study Identification
Unique Protocol Identification Number
NCT00985439
Brief Title
Study of Diclofenac Capsules to Treat Dental Pain
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 Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Iroko Pharmaceuticals, LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether Diclofenac Test Formulation Capsules are safe and effective for the treatment of dental pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
202 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diclofenac Test (lower dose)
Arm Type
Experimental
Arm Description
One 18-mg Diclofenac Test Capsule and 1 placebo capsule
Arm Title
Diclofenac Test (upper dose)
Arm Type
Experimental
Arm Description
One 35-mg Diclofenac Test Capsule and 1 placebo capsule
Arm Title
Celecoxib 400 mg
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Diclofenac Test (lower dose)
Intervention Description
18-mg Single dose
Intervention Type
Drug
Intervention Name(s)
Diclofenac Test (upper dose)
Intervention Description
35-mg Single dose
Intervention Type
Drug
Intervention Name(s)
Celecoxib 400 mg
Intervention Description
Capsules 2 x 200 mg Single-dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Capsules 2 Single-dose
Primary Outcome Measure Information:
Title
Total Patient Pain Relief Over 0 to 12 Hours.
Description
Total patient pain relief was assessed as a time-weighted sum of the patient pain assessments at each individual time point 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.
Time Frame
12 hours.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Premier Research Group Limited
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
12. IPD Sharing Statement
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Study of Diclofenac Capsules to Treat Dental Pain
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