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

Phase 3

Completed

• Conditions: Pain, Postoperative
• Interventions: Drug: diclofenac potassium (XP21L); Drug: Placebo

• Registration Number: NCT00375934
• Lead Sponsor: Xanodyne Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-09-11
• Study First Submitted QC: 2006-09-11
• Study First Posted: 2006-09-13
• Primary Completion: 2007-01
• Results First Submitted: 2010-03-22
• Status Verified: 2010-05
• Results First Submitted QC: 2010-05-24
• Results First Posted: 2010-06-22
• Last Update Submitted: 2010-09-17
• Last Update Posted: 2010-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	diclofenac potassium (XP21L)	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Median Time to Onset of Pain Relief in Patients With Perceptible Pain Relief on Day 1	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
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 With at Least 30% Reduction in Pain Intensity After First Dose of Study Drug	8 hours post single dose
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.
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.
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 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.

Trial Locations

Locations (1)

Investigative Site; 🇺🇸 Salt Lake City, Utah, United States