Efficacy of XP20B Following Bunionectomy Surgery | NCT00655291

Studies
Efficacy of XP20B Following Bunionectomy Surgery

NCT00655291

Sponsor

Xanodyne Pharmaceuticals

Status

Completed

Last Update Posted

Oct 8, 2008Estimated

Enrollment

190Estimated

Phase

Phase 3

Conditions

Acute Pain

Interventions

XP20B
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2008

Primary Completion Date

Aug 2008Actual

Completion Date

Aug 2008Actual

First Submitted Date

Apr 3, 2008

First Submission Date that Met QC Criteria

Apr 3, 2008

First Posted Date

Apr 9, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 7, 2008

Last Update Posted Date

Oct 8, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine if XP20B is an effective treatment for the relief of pain following bunionectomy surgery.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

190Estimated

Label	Type	Description	Intervention Names
A	Placebo Comparator		Drug: Placebo
B	Experimental		Drug: XP20B

Name	Type	Description	Arm Group Labels	Other Names
XP20B	Drug		B
Placebo	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Average pain over a fixed dosing period		Multiple-day

Secondary Outcomes

Measure	Description	Time Frame
multiple pain assessments over a fixed dosing period		Multiple-day
Rescue medication use		Multiple-day
Safety evaluations

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

having undergone bunionectomy surgery
having achieved the requisite level of pain

Exclusion Criteria:

pregnant or lactating
history of substance abuse
clinically significant condition or lab abnormality
taken any prohibited medications
gastrointestinal bleeding or history of

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Keith Moore, PharmD	Xanodyne Pharmaceuticals

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Investigatve Site		Anaheim	California	92810	United States
Investigative Site

Condition Browse Module

MeSH Terms

ID	Term
D059787	Acute Pain
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

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Browse Branches

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