NCT00366444

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
201

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 21, 2006

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
4.5 years until next milestone

Results Posted

Study results publicly available

April 13, 2011

Completed
Last Updated

April 13, 2011

Status Verified

April 1, 2011

Enrollment Period

2 months

First QC Date

August 17, 2006

Results QC Date

March 22, 2010

Last Update Submit

April 12, 2011

Conditions

Pain, Postoperative

Keywords

BunionectomyBunion surgeryPost-operative pain

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (10)

  • Number of Patients With Perceptible Pain Relief on Day 1

    8 hours post single dose

  • Median Time to Onset of Pain Relief in Patients With Perceptible Pain Relief on Day 1

    8 hours post single dose

  • Number of Patients With Meaningful Pain Relief on Day 1

    8 hours post single dose

  • Median Time to Onset of Pain Relief in Patients With Meaningful Pain Relief on Day 1

    8 hours post single dose

  • Total Pain Relief (TOTPAR) Scores 8 Hours Post Initial Dose of Study Drug

    8 hours post single dose

  • +5 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL
Drug: diclofenac potassium (XP21L)

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

diclofenac potassium (XP21L)DRUG

25 mg every 6 hours

Also known as: Zipsor Liquid Filled Capsule, XP21L
1
PlaceboDRUG

Placebo every 6 hours

2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age
  • Have undergone bunionectomy surgery
  • Have achieved adequate post-surgical pain

You may not qualify if:

  • Confounding medical conditions which preclude study participation
  • Participated in a study of another investigational drug or device within 30 days prior to randomization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Investigative Site

Anaheim, California, 92801, United States

Location

Investigative Site

Orange, California, 92869, United States

Location

Investigative Site

Owings Mills, Maryland, 21117, United States

Location

Investigative Site

Pasadena, Maryland, 21122, United States

Location

Investigative Site

Altoona, Pennsylvania, 15946, United States

Location

Investigative Site

Salt Lake City, Utah, 84124, United States

Location

Related Publications (2)

  • 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.

    PMID: 19922878RESULT

  • 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.

    PMID: 22587481DERIVED

Related Links

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Diclofenac

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Results Point of Contact

Title
Steve Boesing
Organization
Xanodyne Pharmaceuticals, Inc.
clinical-trials@xanodyne.com
1-877-926-6396

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 17, 2006

First Posted

August 21, 2006

Study Start

August 1, 2006

Primary Completion

October 1, 2006

Last Updated

April 13, 2011

Results First Posted

April 13, 2011

Record last verified: 2011-04

Locations

US(6)