Phase 3
N=201
Multicenter Study to Evaluate the Analgesic Efficacy of XP21L in Subjects With Pain Following Bunionectomy Surgery
Pain, Postoperative
Bottom Line
View on ClinicalTrials.gov: NCT00366444 ↗Enrolled (actual)
201
Serious AEs
0.5%
Results posted
Apr 2011
Primary outcome: Primary: Average Numeric Pain Rating Score (NPRS) Over 48 Hours After Bunionectomy — 2.5; 5.6 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- diclofenac potassium (XP21L) (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Xanodyne Pharmaceuticals
- Primary completion
- Oct 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Numeric Pain Rating Score (NPRS) Over 48 Hours After Bunionectomy |
2.5; 5.6 | — |
| SECONDARY Number of Patients With Perceptible Pain Relief on Day 1 |
84; 69 | — |
| SECONDARY Median Time to Onset of Pain Relief in Patients With Perceptible Pain Relief on Day 1 |
26.0; 22.2 | — |
| SECONDARY Number of Patients With Meaningful Pain Relief on Day 1 |
58; 35 | — |
| SECONDARY Median Time to Onset of Pain Relief in Patients With Meaningful Pain Relief on Day 1 |
70.2 | — |
| SECONDARY Total Pain Relief (TOTPAR) Scores 8 Hours Post Initial Dose of Study Drug |
8.2; 2.6 | — |
| SECONDARY Number of Patients With at Least 30% Reduction in Pain Intensity After First Dose of Study Drug |
62; 40 | — |
| SECONDARY Time to Onset of at Least 30% Reduction in Pain Intensity After First Dose of Study Drug |
60 | — |
| SECONDARY Number of Patients Who Required Rescue Medication on Day 1 |
40; 87 | — |
| SECONDARY Number of Patients Who Required Rescue Medication on Day 2 |
22; 64 | — |
| SECONDARY Number of Patients Who Required Rescue Medication on Day 3 |
5; 29 | — |
Summary
A multicenter study to evaluate the analgesic efficacy of XP21L in subjects with pain following bunionectomy surgery.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00366444). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.