Dental Pain
Conditions
Brief summary
The purpose of the study is to determine whether Naproxen Test Formulation Capsules are safe and effective for the treatment of dental pain.
Interventions
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
Yes
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 |
|---|---|---|
| Analysis of Total Pain Relief (TOTPAR) Over 0 to 12 Hours (TOTPAR-12) After Time 0 | Over 0 to 12 Hours | Total pain relief as computed as a time-weighted sum of individual patient pain relief scores at each timepoint 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 |
|---|---|
| Naproxen Test (Lower Dose) | 51 |
| Naproxen Test (Upper Dose) | 51 |
| Naprosyn 250 mg | 50 |
| Naprosyn 500 mg | 51 |
| Placebo | 51 |
| Total | 254 |
Baseline characteristics
| Characteristic | Naproxen Test (Upper Dose) | Naprosyn 250 mg | Naprosyn 500 mg | Naproxen Test (Lower Dose) | Placebo | Total |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 51 Participants | 50 Participants | 51 Participants | 51 Participants | 51 Participants | 254 Participants |
| Age Continuous | 21.1 years STANDARD_DEVIATION 3.29 | 20.7 years STANDARD_DEVIATION 2.2 | 20.9 years STANDARD_DEVIATION 2.88 | 21.1 years STANDARD_DEVIATION 2.93 | 21.1 years STANDARD_DEVIATION 3.02 | 21.0 years STANDARD_DEVIATION 2.87 |
| Region of Enrollment United States | 51 participants | 50 participants | 51 participants | 51 participants | 51 participants | 254 participants |
| Sex: Female, Male Female | 30 Participants | 32 Participants | 21 Participants | 33 Participants | 32 Participants | 148 Participants |
| Sex: Female, Male Male | 21 Participants | 18 Participants | 30 Participants | 18 Participants | 19 Participants | 106 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 28 / 51 | 27 / 51 | 25 / 50 | 26 / 51 | 31 / 51 |
| serious Total, serious adverse events | 1 / 50 | 0 / 51 | 0 / 50 | 0 / 51 | 0 / 51 |
Outcome results
Primary
Analysis of Total Pain Relief (TOTPAR) Over 0 to 12 Hours (TOTPAR-12) After Time 0
Total pain relief as computed as a time-weighted sum of individual patient pain relief scores at each timepoint 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: Over 0 to 12 Hours
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Naproxen Test (Lower Dose) | Analysis of Total Pain Relief (TOTPAR) Over 0 to 12 Hours (TOTPAR-12) After Time 0 | 25.868 units on a scale |
| Naproxen Test (Upper Dose) | Analysis of Total Pain Relief (TOTPAR) Over 0 to 12 Hours (TOTPAR-12) After Time 0 | 31.948 units on a scale |
| Naprosyn 250 mg | Analysis of Total Pain Relief (TOTPAR) Over 0 to 12 Hours (TOTPAR-12) After Time 0 | 24.373 units on a scale |
| Naprosyn 500 mg | Analysis of Total Pain Relief (TOTPAR) Over 0 to 12 Hours (TOTPAR-12) After Time 0 | 28.549 units on a scale |
| Placebo | Analysis of Total Pain Relief (TOTPAR) Over 0 to 12 Hours (TOTPAR-12) After Time 0 | 9.531 units on a scale |
p-value: <0.00195% CI: [16.923, 27.91]ANCOVA