Pain, Postoperative
Conditions
Keywords
Bunionectomy, Bunion surgery, Post-operative pain
Brief summary
A multicenter study to evaluate the analgesic efficacy of XP21L in subjects with pain following bunionectomy surgery.
Interventions
25 mg capsule, every 6 hours
DRUGPlacebo
Oral placebo capsule, every 6 hours
Sponsors
Xanodyne Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 18-65 years of age * Have undergone bunionectomy surgery * Have achieved adequate post-surgical pain
Exclusion criteria
* Confounding medical conditions which preclude study participation * Participated in a study of another investigational drug or device within 30 days prior to randomization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Numeric Pain Rating Score (NPRS) Over 48 Hours After Bunionectomy | Over 48 hours after bunionectomy | Pain intensity scores were measured using an 11-point numerical pain rating scale (NPRS) with 0=no pain to 10=worst possible pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median Time to Onset of Pain Relief in Patients With Perceptible Pain Relief on Day 1 | 8 hours post single dose | — |
| Number of Patients With Meaningful Pain Relief on Day 1 | 8 hours post single dose | Times to onset of Perceptible and Meaningful Relief were determined using the double-stopwatch method. |
| Median Time to Onset of Pain Relief in Patients With Meaningful Pain Relief on Day 1 | 8 hours post single dose | — |
| Total Pain Relief (TOTPAR) Scores 8 Hours Post Initial Dose of Study Drug | 8 hourse post single dose | Pain relief was rated using a 5-point categorial scale (0=none, 1=a little, 2=some, 3=a lot, and 4=complete) at time of dose (time=0) and over 15 time points afterwards (10, 15, 20, 30, 45, and 60 minutes and at 1.5, 2, 2.5, 3, 4, 5, 6, 7, and 8 hours after the initial dose on Day 1 or until time of re-medication). A score of 0 across all time points would be the lowest (worst) and a score of 60 (4 X 15 time points) would be the highest (best) possible score. |
| Number of Patients With Perceptible Pain Relief on Day 1 | 8 hours post single dose | Times to onset of Perceptible and Meaningful Relief were determined using the double-stopwatch method. |
| Time to Onset of at Least 30% Reduction in Pain Intensity After First Dose of Study Drug | 8 hours post single dose | — |
| Number of Patients Who Required Rescue Medication on Day 1 | Day 1 | — |
| Number of Patients Who Required Rescue Medication on Day 2 | Day 2 | — |
| Number of Patients Who Required Rescue Medication on Day 3 | Day 3 | Day 3 data reflect the use of rescue medication only up to the time of discharge. |
| Number of Patients With at Least 30% Reduction in Pain Intensity After First Dose of Study Drug | 8 hours post single dose | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Zipsor (Diclofenac Potassium) Liquid Filled Capsule 25 mg capsule, every 6 hours | 99 |
| Placebo Oral placebo capsule, every 6 hours | 101 |
| Total | 200 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Lack of Efficacy | 0 | 2 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | Zipsor (Diclofenac Potassium) Liquid Filled Capsule | Placebo | Total |
|---|---|---|---|
| Age Continuous | 41 years STANDARD_DEVIATION 13 | 40 years STANDARD_DEVIATION 12 | 40 years STANDARD_DEVIATION 12 |
| Baseline Pain Score | 7.5 units on a scale STANDARD_DEVIATION 1.6 | 7.4 units on a scale STANDARD_DEVIATION 1.4 | 7.5 units on a scale STANDARD_DEVIATION 1.5 |
| Race/Ethnicity, Customized Asian | 2 participants | 2 participants | 4 participants |
| Race/Ethnicity, Customized Black | 8 participants | 15 participants | 23 participants |
| Race/Ethnicity, Customized Caucasian | 66 participants | 57 participants | 123 participants |
| Race/Ethnicity, Customized Hispanic | 21 participants | 26 participants | 47 participants |
| Race/Ethnicity, Customized Other | 2 participants | 1 participants | 3 participants |
| Region of Enrollment United States | 99 participants | 101 participants | 200 participants |
| Sex: Female, Male Female | 86 Participants | 86 Participants | 172 Participants |
| Sex: Female, Male Male | 13 Participants | 15 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 46 / 99 | 63 / 101 |
| serious Total, serious adverse events | 0 / 99 | 1 / 101 |
Outcome results
Primary
Average Numeric Pain Rating Score (NPRS) Over 48 Hours After Bunionectomy
Pain intensity scores were measured using an 11-point numerical pain rating scale (NPRS) with 0=no pain to 10=worst possible pain
Time frame: Over 48 hours after bunionectomy
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Zipsor (Diclofenac Potassium) Liquid Filled Capsule | Average Numeric Pain Rating Score (NPRS) Over 48 Hours After Bunionectomy | 3.3 units on a scale | Standard Deviation 2.2 |
| Placebo | Average Numeric Pain Rating Score (NPRS) Over 48 Hours After Bunionectomy | 5.7 units on a scale | Standard Deviation 2.1 |
Secondary
Median Time to Onset of Pain Relief in Patients With Meaningful Pain Relief on Day 1
Time frame: 8 hours post single dose
Population: Number of participants analyzed includes only the number of participants with meaningful pain relief on Day 1 (see previous outcome measure #4).~Number of patients in the placebo group is intentionally blank as the data (eg., median and upper CI) were not calculable (see post-hoc outcome measure #12 for available placebo results).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Zipsor (Diclofenac Potassium) Liquid Filled Capsule | Median Time to Onset of Pain Relief in Patients With Meaningful Pain Relief on Day 1 | 90.6 minutes |
Secondary
Median Time to Onset of Pain Relief in Patients With Perceptible Pain Relief on Day 1
Time frame: 8 hours post single dose
Population: Number of participants analyzed includes only the number of participants with perceptible pain relief on Day 1 (see previous outcome measure #2).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Zipsor (Diclofenac Potassium) Liquid Filled Capsule | Median Time to Onset of Pain Relief in Patients With Perceptible Pain Relief on Day 1 | 42.9 minutes |
| Placebo | Median Time to Onset of Pain Relief in Patients With Perceptible Pain Relief on Day 1 | 36.0 minutes |
Secondary
Number of Patients Who Required Rescue Medication on Day 1
Time frame: Day 1
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zipsor (Diclofenac Potassium) Liquid Filled Capsule | Number of Patients Who Required Rescue Medication on Day 1 | 53 participants |
| Placebo | Number of Patients Who Required Rescue Medication on Day 1 | 93 participants |
Secondary
Number of Patients Who Required Rescue Medication on Day 2
Time frame: Day 2
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zipsor (Diclofenac Potassium) Liquid Filled Capsule | Number of Patients Who Required Rescue Medication on Day 2 | 30 participants |
| Placebo | Number of Patients Who Required Rescue Medication on Day 2 | 68 participants |
Secondary
Number of Patients Who Required Rescue Medication on Day 3
Day 3 data reflect the use of rescue medication only up to the time of discharge.
Time frame: Day 3
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zipsor (Diclofenac Potassium) Liquid Filled Capsule | Number of Patients Who Required Rescue Medication on Day 3 | 4 participants |
| Placebo | Number of Patients Who Required Rescue Medication on Day 3 | 19 participants |
Secondary
Number of Patients With at Least 30% Reduction in Pain Intensity After First Dose of Study Drug
Time frame: 8 hours post single dose
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zipsor (Diclofenac Potassium) Liquid Filled Capsule | Number of Patients With at Least 30% Reduction in Pain Intensity After First Dose of Study Drug | 51 participants |
| Placebo | Number of Patients With at Least 30% Reduction in Pain Intensity After First Dose of Study Drug | 31 participants |
Secondary
Number of Patients With Meaningful Pain Relief on Day 1
Times to onset of Perceptible and Meaningful Relief were determined using the double-stopwatch method.
Time frame: 8 hours post single dose
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zipsor (Diclofenac Potassium) Liquid Filled Capsule | Number of Patients With Meaningful Pain Relief on Day 1 | 50 participants |
| Placebo | Number of Patients With Meaningful Pain Relief on Day 1 | 30 participants |
Secondary
Number of Patients With Perceptible Pain Relief on Day 1
Times to onset of Perceptible and Meaningful Relief were determined using the double-stopwatch method.
Time frame: 8 hours post single dose
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zipsor (Diclofenac Potassium) Liquid Filled Capsule | Number of Patients With Perceptible Pain Relief on Day 1 | 72 participants |
| Placebo | Number of Patients With Perceptible Pain Relief on Day 1 | 63 participants |
Secondary
Time to Onset of at Least 30% Reduction in Pain Intensity After First Dose of Study Drug
Time frame: 8 hours post single dose
Population: Number of participants analyzed includes only the number of participants with at least 30% reduction in pain intensity after first dose of study drug (see previous outcome measure #7).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Zipsor (Diclofenac Potassium) Liquid Filled Capsule | Time to Onset of at Least 30% Reduction in Pain Intensity After First Dose of Study Drug | 110 minutes |
| Placebo | Time to Onset of at Least 30% Reduction in Pain Intensity After First Dose of Study Drug | 300 minutes |
Secondary
Total Pain Relief (TOTPAR) Scores 8 Hours Post Initial Dose of Study Drug
Pain relief was rated using a 5-point categorial scale (0=none, 1=a little, 2=some, 3=a lot, and 4=complete) at time of dose (time=0) and over 15 time points afterwards (10, 15, 20, 30, 45, and 60 minutes and at 1.5, 2, 2.5, 3, 4, 5, 6, 7, and 8 hours after the initial dose on Day 1 or until time of re-medication). A score of 0 across all time points would be the lowest (worst) and a score of 60 (4 X 15 time points) would be the highest (best) possible score.
Time frame: 8 hourse post single dose
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Zipsor (Diclofenac Potassium) Liquid Filled Capsule | Total Pain Relief (TOTPAR) Scores 8 Hours Post Initial Dose of Study Drug | 5.9 units on a scale | Standard Deviation 7.4 |
| Placebo | Total Pain Relief (TOTPAR) Scores 8 Hours Post Initial Dose of Study Drug | 1.9 units on a scale | Standard Deviation 3.6 |