Multicenter Study to Evaluate the Analgesic Efficacy of XP21L in Subjects With Pain Following Bunionectomy Surgery

Study Overview
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Brief Summary
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A multicenter study to evaluate the analgesic efficacy of XP21L in subjects with pain following bunionectomy surgery.

Official Title
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Multicenter Study to Evaluate the Analgesic Efficacy of XP21L in Subjects With Pain Following Bunionectomy Surgery

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: diclofenac potassium (XP21L)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: diclofenac potassium (XP21L)<br>* 25 mg capsule, every 6 hours<br>* Other names: XP21L;|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* Oral placebo capsule, every 6 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Over 48 hours after bunionectomy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 8 hours post single dose | 
| 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 | Times to onset of Perceptible and Meaningful Relief were determined using the double-stopwatch method. | 8 hours post single dose | 
| 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 | 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. | 8 hourse post single dose | 
| Number of Patients With at Least 30% Reduction in Pain Intensity After First Dose of Study Drug |  | 8 hours post single dose | 
| 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 data reflect the use of rescue medication only up to the time of discharge. | Day 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bunionectomy, Bunion surgery, Post-operative pain