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

This study has been completed.
Sponsor:
Information provided by:
Xanodyne Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00366444
First received: August 17, 2006
Last updated: April 12, 2011
Last verified: April 2011
  Purpose

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


Condition Intervention Phase
Pain, Postoperative
Drug: diclofenac potassium (XP21L)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Multicenter Study to Evaluate the Analgesic Efficacy of XP21L in Subjects With Pain Following Bunionectomy Surgery

Resource links provided by NLM:


Further study details as provided by Xanodyne Pharmaceuticals:

Primary Outcome Measures:
  • Average Numeric Pain Rating Score (NPRS) Over 48 Hours After Bunionectomy [ Time Frame: Over 48 hours after bunionectomy ] [ Designated as safety issue: No ]
    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:
  • Number of Patients With Perceptible Pain Relief on Day 1 [ Time Frame: 8 hours post single dose ] [ Designated as safety issue: No ]
    Times to onset of Perceptible and Meaningful Relief were determined using the double-stopwatch method.

  • Median Time to Onset of Pain Relief in Patients With Perceptible Pain Relief on Day 1 [ Time Frame: 8 hours post single dose ] [ Designated as safety issue: No ]
  • Number of Patients With Meaningful Pain Relief on Day 1 [ Time Frame: 8 hours post single dose ] [ Designated as safety issue: No ]
    Times to onset of Perceptible and Meaningful Relief were determined using the double-stopwatch method.

  • Median Time to Onset of Pain Relief in Patients With Meaningful Pain Relief on Day 1 [ Time Frame: 8 hours post single dose ] [ Designated as safety issue: No ]
  • Total Pain Relief (TOTPAR) Scores 8 Hours Post Initial Dose of Study Drug [ Time Frame: 8 hours post single dose ] [ Designated as safety issue: No ]
    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 With at Least 30% Reduction in Pain Intensity After First Dose of Study Drug [ Time Frame: 8 hours post single dose ] [ Designated as safety issue: No ]
  • Time to Onset of at Least 30% Reduction in Pain Intensity After First Dose of Study Drug [ Time Frame: 8 hours post single dose ] [ Designated as safety issue: No ]
  • Number of Patients Who Required Rescue Medication on Day 1 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Number of Patients Who Required Rescue Medication on Day 2 [ Time Frame: Day 2 ] [ Designated as safety issue: No ]
  • Number of Patients Who Required Rescue Medication on Day 3 [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
    Day 3 data reflect the use of rescue medication only up to the time of discharge


Enrollment: 201
Study Start Date: August 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: diclofenac potassium (XP21L)
25 mg every 6 hours
Other Names:
  • Zipsor Liquid Filled Capsule
  • XP21L
Placebo Comparator: 2 Drug: Placebo
Placebo every 6 hours

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00366444

Locations
United States, California
Investigative Site
Anaheim, California, United States, 92801
Investigative Site
Orange, California, United States, 92869
United States, Maryland
Investigative Site
Owings Mills, Maryland, United States, 21117
Investigative Site
Pasadena, Maryland, United States, 21122
United States, Pennsylvania
Investigative Site
Altoona, Pennsylvania, United States, 15946
United States, Utah
Investigative Site
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
Xanodyne Pharmaceuticals
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gary Shangold, MD / Chief Medical Officer, Xanodyne Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00366444     History of Changes
Other Study ID Numbers: XP21L-301
Study First Received: August 17, 2006
Results First Received: March 22, 2010
Last Updated: April 12, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Xanodyne Pharmaceuticals:
Bunionectomy
Bunion surgery
Post-operative pain

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Analgesics
Diclofenac
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014