Clinical trial NCT00366444: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain, Postoperative
Keywords: Bunionectomy
Bunion surgery
Post-operative pain
Lead sponsor: Xanodyne Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2006-08-21
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Average Numeric Pain Rating Score (NPRS) Over 48 Hours After Bunionectomy
timeFrame: Over 48 hours after bunionectomy
Secondary outcomes:
measure: Number of Patients With Perceptible Pain Relief on Day 1
timeFrame: 8 hours post single dose
measure: Median Time to Onset of Pain Relief in Patients With Perceptible Pain Relief on Day 1
timeFrame: 8 hours post single dose
measure: Number of Patients With Meaningful Pain Relief on Day 1
timeFrame: 8 hours post single dose
measure: Median Time to Onset of Pain Relief in Patients With Meaningful Pain Relief on Day 1
timeFrame: 8 hours post single dose
measure: Total Pain Relief (TOTPAR) Scores 8 Hours Post Initial Dose of Study Drug
timeFrame: 8 hours post single dose
measure: Number of Patients With at Least 30% Reduction in Pain Intensity After First Dose of Study Drug
timeFrame: 8 hours post single dose
measure: Time to Onset of at Least 30% Reduction in Pain Intensity After First Dose of Study Drug
timeFrame: 8 hours post single dose
measure: Number of Patients Who Required Rescue Medication on Day 1
timeFrame: Day 1
measure: Number of Patients Who Required Rescue Medication on Day 2
timeFrame: Day 2
measure: Number of Patients Who Required Rescue Medication on Day 3
timeFrame: Day 3
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Investigative Site
state: California
city: Orange
country: United States
facility: Investigative Site
state: California
city: Owings Mills
country: United States
facility: Investigative Site
state: Maryland
city: Pasadena
country: United States
facility: Investigative Site
state: Maryland
city: Altoona
country: United States
facility: Investigative Site
state: Pennsylvania
city: Salt Lake City
country: United States
facility: Investigative Site
state: Utah
Study officials:
References:
citation: Riff DS, Duckor S, Gottlieb I, Diamond E, Soulier S, Raymond G, Boesing SE. Diclofenac potassium liquid-filled soft gelatin capsules in the management of patients with postbunionectomy pain: a Phase III, multicenter, randomized, double-blind, placebo-controlled study conducted over 5 days. Clin Ther. 2009 Oct;31(10):2072-85. doi: 10.1016/j.clinthera.2009.09.011.
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.