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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00375934
• Other study ID #: XP21L-302
• Status: Completed
• Phase: Phase 3
• First received: September 11, 2006
• Last updated: September 17, 2010
• Start date: September 2006

Study information

• Verified date: May 2010
• Source: Xanodyne Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• diclofenac potassium (XP21L)
25 mg capsule, every 6 hours
• Placebo
Oral placebo capsule, every 6 hours

Locations

Country	Name	City	State
United States	Investigative Site	Austin	Texas
United States	Investigative Site	Houston	Texas
United States	Investigative Site	Salt Lake City	Utah
United States	Investigative Site	San Marcos	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Xanodyne Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Median Time to Onset of Pain Relief in Patients With Perceptible Pain Relief on Day 1		8 hours post single dose	No
Secondary	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	No
Secondary	Median Time to Onset of Pain Relief in Patients With Meaningful Pain Relief on Day 1		8 hours post single dose	No
Secondary	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	No
Secondary	Number of Patients With at Least 30% Reduction in Pain Intensity After First Dose of Study Drug		8 hours post single dose	No
Secondary	Time to Onset of at Least 30% Reduction in Pain Intensity After First Dose of Study Drug		8 hours post single dose	No
Secondary	Number of Patients Who Required Rescue Medication on Day 1		Day 1	No
Secondary	Number of Patients Who Required Rescue Medication on Day 2		Day 2	No
Secondary	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	No

External Links

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