Official Title
Multicenter Study to Evaluate the Analgesic Efficacy of XP21L in Subjects With Pain Following Bunionectomy Surgery
Phase
Phase 3Lead Sponsor
Xanodyne PharmaceuticalsStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Pain, PostoperativeIntervention/Treatment
diclofenac ...Study Participants
201A multicenter study to evaluate the analgesic efficacy of XP21L in subjects with pain following bunionectomy surgery.
25 mg every 6 hours
Placebo every 6 hours
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
| Event Type | Organ System | Event Term | Zipsor (Diclofenac Potassium) Liquid Filled Capsule | Placebo |
|---|
Pain intensity scores were measured using an 11-point numerical pain rating scale (NPRS) with 0=no pain to 10=worst possible pain
Times to onset of Perceptible and Meaningful Relief were determined using the double-stopwatch method.
Times to onset of Perceptible and Meaningful Relief were determined using the double-stopwatch method.
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.
Day 3 data reflect the use of rescue medication only up to the time of discharge
