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

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

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: diclofenac potassium (XP21L); Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78705
      • Investigative Site
    • Houston, Texas, United States, 77057
      • Investigative Site
    • San Marcos, Texas, United States, 78666
      • Investigative Site
  • Utah
    • Salt Lake City, Utah, United States, 84117
      • Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: diclofenac potassium (XP21L); 25 mg capsule, every 6 hours; Other Names: Zipsor Liquid Filled Capsule; XP21L
Placebo Comparator: 2	Drug: Placebo; Oral placebo capsule, every 6 hours

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Xanodyne Pharmaceuticals

Publications and helpful links

General Publications

• Daniels SE, Riff D, Diamond E, Clark F, Boesing SE. An assessment of the efficacy and safety of diclofenac potassium liquid-filled capsules in patients with various levels of baseline pain intensity. Curr Med Res Opin. 2012 Jun;28(6):953-61. doi: 10.1185/03007995.2012.694363. Epub 2012 Jun 11.
• Daniels SE, Baum DR, Clark F, Golf MH, McDonnell ME, Boesing SE. Diclofenac potassium liquid-filled soft gelatin capsules for the treatment of postbunionectomy pain. Curr Med Res Opin. 2010 Oct;26(10):2375-84. doi: 10.1185/03007995.2010.515478.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (Actual): January 1, 2007

Study Registration Dates

• First Submitted: September 11, 2006
• First Submitted That Met QC Criteria: September 11, 2006
• First Posted (Estimate): September 13, 2006

Study Record Updates

• Last Update Posted (Estimate): September 21, 2010
• Last Update Submitted That Met QC Criteria: September 17, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: Post-operative pain; Bunionectomy; Bunion surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Diclofenac
• Other Study ID Numbers: XP21L-302