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

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
diclofenac potassium (XP21L)
Placebo
Sponsored by
Xanodyne Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring Bunionectomy, Bunion surgery, Post-operative pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Median Time to Onset of Pain Relief in Patients With Perceptible Pain Relief on Day 1
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.
Median Time to Onset of Pain Relief in Patients With Meaningful Pain Relief on Day 1
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.
Number of Patients With at Least 30% Reduction in Pain Intensity After First Dose of Study Drug
Time to Onset of at Least 30% Reduction in Pain Intensity After First Dose of Study Drug
Number of Patients Who Required Rescue Medication on Day 1
Number of Patients Who Required Rescue Medication on 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.

Full Information

First Posted
September 11, 2006
Last Updated
September 17, 2010
Sponsor
Xanodyne Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00375934
Brief Title
Multicenter Study to Evaluate the Analgesic Efficacy of XP21L in Subjects With Pain Following Bunionectomy Surgery
Official Title
Multicenter Study to Evaluate the Analgesic Efficacy of XP21L in Subjects With Pain Following Bunionectomy Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Xanodyne Pharmaceuticals

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Bunionectomy, Bunion surgery, Post-operative pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
diclofenac potassium (XP21L)
Other Intervention Name(s)
Zipsor Liquid Filled Capsule, XP21L
Intervention Description
25 mg capsule, every 6 hours
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral placebo capsule, every 6 hours
Primary Outcome Measure Information:
Title
Average Numeric Pain Rating Score (NPRS) Over 48 Hours After Bunionectomy
Description
Pain intensity scores were measured using an 11-point numerical pain rating scale (NPRS) with 0=no pain to 10=worst possible pain
Time Frame
Over 48 hours after bunionectomy
Secondary Outcome Measure Information:
Title
Number of Patients With Perceptible Pain Relief on Day 1
Description
Times to onset of Perceptible and Meaningful Relief were determined using the double-stopwatch method.
Time Frame
8 hours post single dose
Title
Median Time to Onset of Pain Relief in Patients With Perceptible Pain Relief on Day 1
Time Frame
8 hours post single dose
Title
Number of Patients With Meaningful Pain Relief on Day 1
Description
Times to onset of Perceptible and Meaningful Relief were determined using the double-stopwatch method.
Time Frame
8 hours post single dose
Title
Median Time to Onset of Pain Relief in Patients With Meaningful Pain Relief on Day 1
Time Frame
8 hours post single dose
Title
Total Pain Relief (TOTPAR) Scores 8 Hours Post Initial Dose of Study Drug
Description
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.
Time Frame
8 hourse post single dose
Title
Number of Patients With at Least 30% Reduction in Pain Intensity After First Dose of Study Drug
Time Frame
8 hours post single dose
Title
Time to Onset of at Least 30% Reduction in Pain Intensity After First Dose of Study Drug
Time Frame
8 hours post single dose
Title
Number of Patients Who Required Rescue Medication on Day 1
Time Frame
Day 1
Title
Number of Patients Who Required Rescue Medication on Day 2
Time Frame
Day 2
Title
Number of Patients Who Required Rescue Medication on Day 3
Description
Day 3 data reflect the use of rescue medication only up to the time of discharge.
Time Frame
Day 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Investigative Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Investigative Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77057
Country
United States
Facility Name
Investigative Site
City
San Marcos
State/Province
Texas
ZIP/Postal Code
78666
Country
United States
Facility Name
Investigative Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84117
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22587481
Citation
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.
Results Reference
derived
PubMed Identifier
20804444
Citation
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.
Results Reference
derived
Links:
URL
http://www.zipsor.com/
Description
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Multicenter Study to Evaluate the Analgesic Efficacy of XP21L in Subjects With Pain Following Bunionectomy Surgery

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