Dental Pain
Conditions
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.
Interventions
18-mg Single dose
35-mg Single dose
DRUGCelecoxib 400 mg
Capsules 2 x 200 mg Single-dose
DRUGPlacebo
Capsules 2 Single-dose
Sponsors
Iroko Pharmaceuticals, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Patient Pain Relief Over 0 to 12 Hours. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Diclofenac Test (Lower Dose) | 49 |
| Diclofenac Test (Upper Dose) | 51 |
| Celecoxib 400 mg | 51 |
| Placebo | 51 |
| Total | 202 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Diclofenac Test (Upper Dose) | Celecoxib 400 mg | Diclofenac Test (Lower Dose) | Placebo | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 51 Participants | 51 Participants | 49 Participants | 51 Participants | 202 Participants |
| Age Continuous | 22.3 years STANDARD_DEVIATION 4.58 | 22.7 years STANDARD_DEVIATION 3.3 | 22.1 years STANDARD_DEVIATION 5.1 | 22.6 years STANDARD_DEVIATION 4.22 | 22.4 years STANDARD_DEVIATION 4.32 |
| Region of Enrollment United States | 51 participants | 51 participants | 49 participants | 51 participants | 202 participants |
| Sex: Female, Male Female | 30 Participants | 34 Participants | 27 Participants | 25 Participants | 116 Participants |
| Sex: Female, Male Male | 21 Participants | 17 Participants | 22 Participants | 26 Participants | 86 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 27 / 49 | 31 / 51 | 32 / 51 | 27 / 51 |
| serious Total, serious adverse events | 0 / 49 | 0 / 51 | 0 / 51 | 0 / 51 |
Outcome results
Primary
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.
Time frame: 12 hours.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Diclofenac Test (Lower Dose) | Total Patient Pain Relief Over 0 to 12 Hours. | 17.770 units on a scale | 95% Confidence Interval 13.7607 |
| Diclofenac Test (Upper Dose) | Total Patient Pain Relief Over 0 to 12 Hours. | 16.893 units on a scale | 95% Confidence Interval 12.7634 |
| Celecoxib 400 mg | Total Patient Pain Relief Over 0 to 12 Hours. | 14.685 units on a scale | 95% Confidence Interval 15.0524 |
| Placebo | Total Patient Pain Relief Over 0 to 12 Hours. | 5.486 units on a scale | 95% Confidence Interval 11.5272 |
p-value: <0.00195% CI: [6.195, 16.619]ANCOVA