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

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ClinicalTrials.gov Identifier: NCT00375934
Recruitment Status : Completed
First Posted : September 13, 2006
Results First Posted : June 22, 2010
Last Update Posted : September 21, 2010
Sponsor:
Information provided by:
Xanodyne Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: diclofenac potassium (XP21L) Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Multicenter Study to Evaluate the Analgesic Efficacy of XP21L in Subjects With Pain Following Bunionectomy Surgery
Study Start Date : September 2006
Actual Primary Completion Date : January 2007

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Average Numeric Pain Rating Score (NPRS) Over 48 Hours After Bunionectomy [ Time Frame: 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 :
  1. Number of Patients With Perceptible Pain Relief on Day 1 [ Time Frame: 8 hours post single dose ]
    Times to onset of Perceptible and Meaningful Relief were determined using the double-stopwatch method.

  2. Median Time to Onset of Pain Relief in Patients With Perceptible Pain Relief on Day 1 [ Time Frame: 8 hours post single dose ]
  3. Number of Patients With Meaningful Pain Relief on Day 1 [ Time Frame: 8 hours post single dose ]
    Times to onset of Perceptible and Meaningful Relief were determined using the double-stopwatch method.

  4. Median Time to Onset of Pain Relief in Patients With Meaningful Pain Relief on Day 1 [ Time Frame: 8 hours post single dose ]
  5. Total Pain Relief (TOTPAR) Scores 8 Hours Post Initial Dose of Study Drug [ Time Frame: 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.

  6. Number of Patients With at Least 30% Reduction in Pain Intensity After First Dose of Study Drug [ Time Frame: 8 hours post single dose ]
  7. Time to Onset of at Least 30% Reduction in Pain Intensity After First Dose of Study Drug [ Time Frame: 8 hours post single dose ]
  8. Number of Patients Who Required Rescue Medication on Day 1 [ Time Frame: Day 1 ]
  9. Number of Patients Who Required Rescue Medication on Day 2 [ Time Frame: Day 2 ]
  10. Number of Patients Who Required Rescue Medication on Day 3 [ Time Frame: Day 3 ]
    Day 3 data reflect the use of rescue medication only up to the time of discharge.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00375934


Locations
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United States, Texas
Investigative Site
Austin, Texas, United States, 78705
Investigative Site
Houston, Texas, United States, 77057
Investigative Site
San Marcos, Texas, United States, 78666
United States, Utah
Investigative Site
Salt Lake City, Utah, United States, 84117
Sponsors and Collaborators
Xanodyne Pharmaceuticals
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Gary Shangold, M.D. / Chief Medical Officer, Xanodyne Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00375934    
Other Study ID Numbers: XP21L-302
First Posted: September 13, 2006    Key Record Dates
Results First Posted: June 22, 2010
Last Update Posted: September 21, 2010
Last Verified: May 2010
Keywords provided by Xanodyne Pharmaceuticals:
Bunionectomy
Bunion surgery
Post-operative pain
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action